Data / Medical devices / Medical Glove, Specialty
Medical Glove, Specialty (LZC): 176 FDA-registered makers in 16 countries
176 establishments in 16 countries are registered with the FDA to make Medical Glove, Specialty (product code LZC, Class 1, 21 CFR 880.6250). 45 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 79 510(k) clearances under this code, the latest on January 14, 2026, and lists 5 recall events (0 Class I). FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Product code
- LZC
- Device class
- 1
- Regulation
- 880.6250
- Medical specialty
- General Hospital
Makers by country
| Country | Makers |
|---|---|
| Malaysia | 53 |
| China | 38 |
| United States | 36 |
| Thailand | 16 |
| Vietnam | 11 |
| Indonesia | 10 |
| Sri Lanka | 2 |
| Cambodia | 2 |
| Singapore | 1 |
| Canada | 1 |
| Ireland | 1 |
| Italy | 1 |
| India | 1 |
| Austria | 1 |
| Honduras | 1 |
| Taiwan | 1 |
Makers of Medical Glove, Specialty
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| O&M Halyard, Inc. | Alpharetta, GA, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 15 | October 11, 2020 | 0 | 2 | 0 | api.fda.gov |
| Ansell Healthcare Products LLC | Reno, NV, United States | Manufacturer, Specification developer | 8 | October 23, 2019 | 0 | 0 | 0 | api.fda.gov |
| Safeskin Medical & Scientific (thailand), Ltd. | SADAO Songkhla, Thailand | Manufacturer, Specification developer | 8 | October 11, 2020 | 0 | 0 | 0 | api.fda.gov |
| Kossan International Sdn Bhd | Shah Alam Selangor, Malaysia | Exporter to the US, Specification developer | 6 | November 29, 2010 | 0 | 0 | 0 | api.fda.gov |
| WRP Asia Pacific Sdn. Bhd. | SALAK TINGGI, SEPANG Selangor, Malaysia | Complaint file establishment, Contract manufacturer, Manufacturer | 5 | February 5, 2015 | 0 | 0 | 0 | api.fda.gov |
| Yty Industry (manjung) Sdn. Bhd. | SITIAWAN Perak, Malaysia | Contract manufacturer, Manufacturer | 5 | September 18, 2020 | 0 | 0 | 0 | api.fda.gov |
| Central Medicare Sdn Bhd | Teluk Intan Perak, Malaysia | Contract manufacturer, Manufacturer | 4 | July 4, 2019 | 0 | 0 | 0 | api.fda.gov |
| HARPS Investment Asia Pte. Ltd. | Singapore Central Singapore, Singapore | Exporter to the US, Manufacturer, Specification developer | 4 | March 14, 2012 | 0 | 0 | 0 | api.fda.gov |
| Cardinal Health | Hazelwood, MO, United States | Specification developer | 3 | January 14, 2026 | 0 | 0 | 0 | api.fda.gov |
| GMP Medicare Sdn Bhd(F25) | Klang Selangor, Malaysia | Contract manufacturer, Manufacturer | 3 | August 29, 2019 | 0 | 0 | 0 | api.fda.gov |
| GP Lumut | Sitiawan Perak, Malaysia | Contract manufacturer, Manufacturer | 3 | June 27, 2018 | 0 | 0 | 0 | api.fda.gov |
| Latexx Manufacturing Sdn. Bhd. | TAIPING Perak, Malaysia | Contract manufacturer, Manufacturer | 3 | March 14, 2012 | 0 | 0 | 0 | api.fda.gov |
| Perusahaan Getah Asas Sdn. Bhd. | JERAM Selangor, Malaysia | Contract manufacturer, Manufacturer | 3 | November 29, 2010 | 0 | 0 | 0 | api.fda.gov |
| Yty Acheh | Sitiawan Perak, Malaysia | Contract manufacturer, Manufacturer | 3 | June 27, 2018 | 0 | 0 | 0 | api.fda.gov |
| Comfort Rubber Gloves Industries Sdn Bhd | TAIPING Perak, Malaysia | Contract manufacturer, Exporter to the US, Manufacturer | 2 | May 15, 2018 | 0 | 0 | 0 | api.fda.gov |
| Hebei Titans Hongsen Medical Technology Co.,ltd | Xingtai Hebei, China | Manufacturer | 2 | August 10, 2018 | 0 | 0 | 0 | api.fda.gov |
| JR Engineering And Medical Technologies (M) Sdn Bhd | RASA Selangor, Malaysia | Manufacturer | 2 | August 30, 2022 | 0 | 0 | 0 | api.fda.gov |
| TG Medical Sdn Bhd | KLANG Selangor, Malaysia | Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler | 2 | August 29, 2019 | 0 | 0 | 0 | api.fda.gov |
| AMD Medicom Inc. | Pointe-Claire, Montreal Quebec, Canada | Complaint file establishment, Exporter to the US, Foreign private label distributor, Specification developer | 1 | March 19, 2019 | 0 | 0 | 0 | api.fda.gov |
| Ansell Seremban Sdn. Bhd | Seremban Negeri Sembilan, Malaysia | Manufacturer | 1 | July 24, 2017 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Marlborough, MA, United States | Specification developer | 1 | May 22, 1989 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Spencer, IN, United States | Manufacturer | 1 | May 22, 1989 | 0 | 0 | 0 | api.fda.gov |
| Brightway Holdings Sdn. Bhd. | KLANG, Selangor, Malaysia | Manufacturer | 1 | March 31, 2017 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Coventry, RI, United States | Manufacturer | 1 | May 22, 1989 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Limited | GALWAY Galway(County), Ireland | Manufacturer | 1 | May 22, 1989 | 0 | 0 | 0 | api.fda.gov |
| Eco Medi Glove Sdn Bhd | Taiping Perak, Malaysia | Contract manufacturer, Manufacturer | 1 | November 13, 2003 | 0 | 0 | 0 | api.fda.gov |
| Emerson & Co. S.R.L. | GENOA Genova, Italy | Manufacturer | 1 | December 23, 1998 | 0 | 0 | 0 | api.fda.gov |
| Encompass Industries Sdn. Bhd. | KEMAMAN Terengganu, Malaysia | Contract manufacturer, Manufacturer | 1 | October 23, 2019 | 0 | 0 | 0 | api.fda.gov |
| Ever Global (vietnam) Enterprise Corporation | Dong Nai Province, Vietnam | Manufacturer | 1 | June 4, 2020 | 0 | 0 | 0 | api.fda.gov |
| Ever Global (vietnam) Enterprise Corporation | An Phuoc Village Dong Nai, Vietnam | Contract manufacturer, Manufacturer | 1 | June 4, 2020 | 0 | 0 | 0 | api.fda.gov |
| GX Corporation Sdn Bhd (Specialty Plant) | Klang Selangor, Malaysia | Contract manufacturer, Manufacturer | 1 | November 2, 2009 | 0 | 0 | 0 | api.fda.gov |
| Hartalega NGC Sdn. Bhd. (lot 39496) | Sepang Selangor, Malaysia | Manufacturer | 1 | June 25, 2012 | 0 | 0 | 0 | api.fda.gov |
| Hartalega Sdn Bhd | Bestari Jaya Selangor, Malaysia | Specification developer | 1 | June 25, 2012 | 0 | 0 | 0 | api.fda.gov |
| HL Rubber Industries Sdn Bhd | KUALA PILAH Negeri Sembilan, Malaysia | Contract manufacturer, Manufacturer | 1 | May 26, 2022 | 0 | 0 | 0 | api.fda.gov |
| Haywood Vocational Opportunities Inc. | Waynesville, NC, United States | Contract manufacturer, Repackager or relabeler | 1 | November 29, 2010 | 0 | 0 | 0 | api.fda.gov |
| I Quality Rubber Industries Sdn. Bhd. | Matang Perak, Malaysia | Specification developer | 1 | May 15, 2018 | 0 | 0 | 0 | api.fda.gov |
| Kossan Latex Industries (M) Sdn Bhd | KLANG Selangor, Malaysia | Contract manufacturer, Manufacturer | 1 | February 27, 2007 | 0 | 0 | 0 | api.fda.gov |
| Maxter Glove Manufacturing Sdn Bhd | KLANG Selangor, Malaysia | Manufacturer | 1 | May 2, 2018 | 0 | 0 | 0 | api.fda.gov |
| Maxter Healthcare Inc | Rosharon, TX, United States | Manufacturer | 1 | May 2, 2016 | 0 | 0 | 0 | api.fda.gov |
| Mexpo International, Inc. | Union City, CA, United States | Contract manufacturer, Manufacturer | 1 | March 5, 2018 | 0 | 0 | 0 | api.fda.gov |
| Mundy Medical Marketing, Inc. | Calabasas, CA, United States | Manufacturer, Specification developer | 1 | February 13, 1990 | 0 | 0 | 0 | api.fda.gov |
| PT. Medisafe Technologies | Kab. Deli Serdang Sumatera Utara, Indonesia | Contract manufacturer, Manufacturer | 1 | March 19, 2019 | 0 | 0 | 0 | api.fda.gov |
| SGMP Co., Ltd. | Hatyai Songkhla, Thailand | Contract manufacturer, Manufacturer | 1 | November 19, 2010 | 0 | 0 | 0 | api.fda.gov |
| SW Technologies Inc. | Union City, CA, United States | Manufacturer, Remanufacturer, Repackager or relabeler, Reprocessor, Specification developer | 1 | November 21, 2012 | 0 | 0 | 0 | api.fda.gov |
| Usa Scientific, Inc. | Ocala, FL, United States | Repackager or relabeler, Specification developer | 1 | November 29, 2010 | 0 | 0 | 0 | api.fda.gov |
| 3a Glove Sdn. Bhd. | Senai Johor, Malaysia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| 4 Cascade Partners, LLC | Renton, WA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| AIMAX HEALTHCARE SDN. BHD. (Formerly known as Hong Seng Gloves Sdn. Bhd.) | SUNGAI PETANI Kedah, Malaysia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alcatron Gloves Factory | Weifang Shandong, China | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| American Armor Gloves | West Columbia, SC, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| American Nitrile Operations LLC | Grove City, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anhui Intco Medical Products Co., Ltd. | Huaibei Anhui, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anrel Distribution LLC | Jackson, NJ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ansell (thailand) Ltd. | THAILAND Krung Thep Maha Nakhon, Thailand | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ansell Lanka (pvt.), Ltd. | BIYAGAMA Gampaha, Sri Lanka | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ansell N.P. Sdn. Bhd. | Melaka, Malaysia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arrow Medsource Group Limited | Hongkong, China | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Avid Medical, Inc. A Medical Action Ind. Company 305 | Toano, VA, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ansell Sterile Solutions Pvt. Ltd | Erode Tamil Nadu, India | Contract manufacturer, Contract sterilizer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bandex Industrial Corp. | Zhuhai City Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Basic International Viet Nam Co.,ltd | QUANG TRUNG WARD Thanh Hoa, Vietnam | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bay Medical | Brisbane, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Better Care Plastic Technology Co., Ltd. | Shenze County Hebei, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| BiometerPlus USA, Inc. | Fremont, CA, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cardinal Health 222 (thailand) Limited | PLUAKDAENG Rayong, Thailand | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cardinal Health 222 (thailand) Limited | PLUAKDAENG Rayong, Thailand | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Careglove Global Sdn Bhd | Seremban Negeri Sembilan, Malaysia | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CM2 | Teluk Intan Perak, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| D&M Procurement | Houston, TX, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dipped Products (thailand) Ltd | AMPHUR KHUN NIENG Songkhla, Thailand | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dynacare Sdn Bhd | Sitiawan Perak, Malaysia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eco Medi Glove Sdn Bhd | Taiping Perak, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eco Medi Glove Sdn Bhd | Taiping Perak, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ever Global (vietnam) Enterprise Corporation | Long Khanh City Dong Nai, Vietnam | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gallant Quality Sdn. Bhd. | Taiping, Perak, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GCB Medical LLC | Duxbury, MA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Genabio Diagnostics Inc | Bedford, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GMP Medicare Sdn Bhd | Siliau Negeri Sembilan, Malaysia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Grand Work Plastic Products Co., Ltd. | ZANHUANG Hebei, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangdong Kingfa Sci.&tech.co.,ltd. | Qingyuan Guangdong, China | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangdong Vyimed Co., Ltd. | Qingyuan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hartalega NGC Sdn Bhd | Sepang Selangor, Malaysia | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| He Chuang Plastic & Rubber Co., Ltd | Zibo Shandong, China | Exporter to the US, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hudson Scientific LLC | Hudson, MI, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Harps Europe Manufacturing | Wimpassing Niederosterreich, Austria | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Honduras Kitting, S.A. | Villanueva Cortes, Honduras | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ideal Quality Sdn Bhd | Klang Selangor, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ideal Quality Sdn Bhd | KLANG Selangor, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jasmine Glove | Hat Yai Songkhla, Thailand | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Cureguard Glove Co., Ltd. | Ulanqab City Inner Mongolia, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangxi Zhonghong Pulin Medical Products Co.,ltd. | jiujiang Jiangxi, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Nanfang Medical Co., Ltd. | CHANGZHOU Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kanglongda Vietnam Protection Technology Company Limited | Phong Dien Thua Thien-Hue, Vietnam | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kl-Kepong Rubber Products Sdn. Bhd. | IPOH Perak, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Koon Seng Sdn Bhd | Tangkak Johor, Malaysia | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| KSG Medicare Sdn Bhd | Tangkak Johor, Malaysia | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Labsource, Inc | Northlake, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lalan Rubbers (pvt) Ltd. | Malwana Gampaha, Sri Lanka | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lingshi Hongruida Health Protection Technology Co., Ltd. | Jinzhong City Shanxi, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mah Sing Healthcare Sdn Bhd | Klang Selangor, Malaysia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Matang MFG. Sdn. Bhd. | MERLIMAU Melaka, Malaysia | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medical Action Industries, Inc. 306 | Arden, NC, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtecs Msez Corp., Ltd. | Krong Bavet Svay Rieng, Cambodia | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mercator Medical (thailand) Ltd. | Ratthaphum Songkhla, Thailand | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Motex Healthcare (anhui) Co., Ltd. | Guangde City, Xuancheng City Anhui, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| North Coast Medical, Inc. | Morgan Hill, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Onetexx Sdn Bhd | Kamunting Perak, Malaysia | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Opus Gloves Co.,ltd. | shanghai, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| P.T. Maja Agung Latexindo | SUNGGAL DELI SERDANG Sumatera Utara, Indonesia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pacewell Asia Sdn. Bhd. | Batu Gajah Perak, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Premier Medical Gloves Factory | Weifang Shandong, China | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Prestige Ameritech | North Richland Hills, TX, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pro-Tech Design & MFG., Inc. | Santa Fe Springs, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Professional Latex Sdn Bhd | Kamunting Perak, Malaysia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Professional Latex Sdn. Bhd. | KAMUNTING Perak, Malaysia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PT Basic International Sumatera | Simalungun Regency Sumatera Utara, Indonesia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PT Greatview Technologies | Simalungun Sumatera Utara, Indonesia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PT Healthguard Technologies | Simalungun Sumatera Utara, Indonesia | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PT K-Tech Industries | Simalungun Sumatera Utara, Indonesia | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PT Newpoint Technology | Simalungun Sumatera Utara, Indonesia | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PT Ywanjan Technology | Pelalawan Regency Riau, Indonesia | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PT. Sintong Unigolden Glove | KISARAN Sumatera Utara, Indonesia | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pt.shamrock Manufacturing Corp. | MEDAN Sumatera Utara, Indonesia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ready Set Import | Beverly Hills, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Riverstone Resources Sdn Bhd | TAIPING Perak, Malaysia | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Riverstone Resources Sdn. Bhd. | BUKIT BERUNTUNG, Selangor, Malaysia | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RMKH Glove (cambodia) Co., Ltd. | Bavet City Svay Rieng, Cambodia | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| S&S Glove Corporation | Ho Chi Minh City, Vietnam | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| S&S Glove Corporation- Branch 1 | Ho Chi Minh City Ba Ria-Vung Tau, Vietnam | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SAS Safety Corp. | Cerritos, CA, United States | Reprocessor | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shandong Blue Sail Health Technology Co., Ltd | Weifang Shandong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shandong Hengya Packaging Printing Co.,ltd | Weifang Shandong, China | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shandong Hysure Safety Tech Co., Ltd | Weifang City Shandong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shandong Intco Medical Products Co Ltd | Qingzhou Shandong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shandong Xingyu Gloves Co., Ltd | Gaomi Shandong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Motex Healthcare Co., Ltd. | Shanghai, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanxi Hongjin Plastic Technology Co., Ltd | Linfen Shanxi, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sna Safehealth Solutions Inc. | Monrovia, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sri Trang Gloves (thailand) Public Company Limited. | Hat Yai Songkhla, Thailand | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stevimed Medical Joint Stock Company | Can Giuoc Commune Tay Ninh, Vietnam | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| STGT Anv | Sadao Songkhla, Thailand | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| STGT CP | Pathio Chumphon, Thailand | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| STGT PS1 | Sadao Songkhla, Thailand | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| STGT SR3 | Kanchanadit Surat Thani, Thailand | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| STGT Surat Thani | Phlai Wat , Kanchanadit Surat Thani, Thailand | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sundex Corporation | Taipei, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SafeSource Direct Glove Plant | Broussard, LA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tekmedic (M) Sdn Bhd | Melaka, Malaysia | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Terang Nusa (malaysia) Sdn. Bhd. | Kota Bharu Kelantan, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Thanh Hoa Medical Technology Co., Ltd. | QUANG TRUNG WARD Thanh Hoa, Vietnam | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| TNG Worldwide Inc | New Hudson, MI, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Top Glove Medical (thailand) Co., Ltd. | Sadao District Songkhla, Thailand | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Top Glove Sdn. Bhd. | KLANG Selangor, Malaysia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| True Glove Factory | Weifang Shandong, China | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Us Medical Glove Company | Harvard, IL, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| US Paper Mill LLC | Chillicothe, OH, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vanda Glove | Pahtong, Hat Yai Songkhla, Thailand | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vietmedical Product Co., Ltd. | QUANG TRUNG WARD Thanh Hoa, Vietnam | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vietwell Technology Vietnam Co., Ltd. | Bim Son Thanh Hoa, Vietnam | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wear Safe (malaysia) Sdn Bhd | KLANG Selangor, Malaysia | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wear Safe (malaysia) Sdn. Bhd. | KLANG Selangor, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wear Safe (malaysia) Sdn. Bhd.-Facility Ii | Klang Selangor, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Weifang Tailai Steel Structure Engineering Co., Ltd | Weifang Shandong, China | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xingyu Medical Tech Co.,ltd | Weifang City Shandong, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xinwei (shandong) Plastic And Rubber Products Co Ltd. | Zibo Shandong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yue Kang Anhui Medical Products Co.,ltd | huaibei Anhui, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhangjiagang Dayu Rubber Products Co., Ltd. | ZHANGJIAGANG CITY Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhonghong Pulin Medical Products Co.,ltd. | Tangshan Hebei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhongnuo Medical Products Co.,ltd. | tangshan Hebei, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zibo Blue Sail Health Technology Co., Ltd | Zibo Shandong, China | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zibo Chengxun Automatic Device Co., Ltd | Zibo Shandong, China | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zibo Kaiyue Mould Technology Co., Ltd | Zibo Shandong, China | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zibo Lanhua Medical Packaging Material Co., Ltd | Zibo Shandong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zibo Sinocare Plastic Products Co., Ltd. | ZIBO Shandong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zibo Blue Sail Innovation Co., Ltd | Zibo Shandong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated January 14, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.