Data / Medical devices / Fentanyl And Other Opioid Protection Glove
Fentanyl And Other Opioid Protection Glove (QDO): 113 FDA-registered makers in 10 countries
113 establishments in 10 countries are registered with the FDA to make Fentanyl And Other Opioid Protection Glove (product code QDO, Class 1, 21 CFR 880.6250). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- QDO
- Device class
- 1
- Regulation
- 880.6250
- Medical specialty
- General Hospital
Makers by country
| Country | Makers |
|---|---|
| Malaysia | 40 |
| China | 21 |
| United States | 16 |
| Thailand | 12 |
| Vietnam | 10 |
| Indonesia | 9 |
| Cambodia | 2 |
| Canada | 1 |
| Singapore | 1 |
| Sri Lanka | 1 |
Makers of Fentanyl And Other Opioid Protection Glove
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 |
|---|---|---|---|---|---|---|---|---|
| 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 | |
| AMD Medicom Inc. | Pointe-Claire, Montreal Quebec, Canada | Complaint file establishment, Exporter to the US, Foreign private label distributor, 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 | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anhui Intco Medical Products Co., Ltd. | Huaibei Anhui, China | 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 Healthcare Products LLC | Reno, NV, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ansell Seremban Sdn. Bhd | Seremban Negeri Sembilan, Malaysia | 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 | |
| Careglove Global Sdn Bhd | Seremban Negeri Sembilan, Malaysia | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Central Medicare Sdn Bhd | Teluk Intan Perak, Malaysia | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Comfort Rubber Gloves Industries Sdn Bhd | TAIPING Perak, Malaysia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cardinal Health | Hazelwood, MO, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| D&M Procurement | Houston, TX, United States | Specification developer | 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, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Encompass Industries Sdn. Bhd. | KEMAMAN Terengganu, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ever Global (vietnam) Enterprise Corporation | Dong Nai Province, Vietnam | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ever Global (vietnam) Enterprise Corporation | Long Khanh City Dong Nai, Vietnam | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ever Global (vietnam) Enterprise Corporation | An Phuoc Village 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 | |
| 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 | |
| GMP Medicare Sdn Bhd(F25) | Klang Selangor, Malaysia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GP Lumut | Sitiawan Perak, Malaysia | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Grand Work Plastic Products Co., Ltd. | ZANHUANG Hebei, China | 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 | |
| GX Corporation Sdn Bhd (Specialty Plant) | Klang Selangor, Malaysia | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| HARPS Investment Asia Pte. Ltd. | Singapore Central Singapore, Singapore | Exporter to the US, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hartalega NGC Sdn Bhd | Sepang Selangor, Malaysia | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hartalega NGC Sdn. Bhd. (lot 39496) | Sepang Selangor, Malaysia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hartalega Sdn Bhd | Bestari Jaya Selangor, Malaysia | Specification developer | 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 | |
| JR Engineering And Medical Technologies (M) Sdn Bhd | RASA Selangor, Malaysia | 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 | |
| Kossan International Sdn Bhd | Shah Alam Selangor, Malaysia | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kossan Latex Industries (M) Sdn Bhd | KLANG Selangor, Malaysia | Contract 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 | |
| Latexx Manufacturing Sdn. Bhd. | TAIPING Perak, Malaysia | Contract manufacturer, 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 | |
| Maxter Healthcare Inc | Rosharon, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | 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 | |
| North Coast Medical, Inc. | Morgan Hill, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| O&M Halyard, Inc. | Alpharetta, GA, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 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 | |
| Perusahaan Getah Asas Sdn. Bhd. | JERAM Selangor, 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 | |
| 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. Medisafe Technologies | Kab. Deli Serdang Sumatera Utara, Indonesia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PT. Sintong Unigolden Glove | KISARAN Sumatera Utara, Indonesia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pt.shamrock Manufacturing Corp. | MEDAN Sumatera Utara, Indonesia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Riverstone Resources Sdn Bhd | TAIPING Perak, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Riverstone Resources Sdn. Bhd. | BUKIT BERUNTUNG, Selangor, Malaysia | Contract 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 | |
| Safeskin Medical & Scientific (thailand), Ltd. | SADAO Songkhla, Thailand | 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 Xingyu Gloves Co., Ltd | Gaomi Shandong, 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 | |
| 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 | |
| SW Technologies Inc. | Union City, CA, United States | Manufacturer, Remanufacturer, Repackager or relabeler, Reprocessor, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| TG Medical Sdn Bhd | KLANG Selangor, Malaysia | Exporter to the US, 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 | |
| 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 | |
| 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 | 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 | |
| WRP Asia Pacific Sdn. Bhd. | SALAK TINGGI, SEPANG Selangor, Malaysia | Manufacturer | 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 | |
| Yty Acheh | Sitiawan Perak, Malaysia | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yty Industry (manjung) Sdn. Bhd. | SITIAWAN Perak, Malaysia | 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 | |
| Zibo Chengxun Automatic Device 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 |
Updated November 2, 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.