Data / Medical devices / Vinyl Patient Examination Glove
Vinyl Patient Examination Glove (LYZ): 78 FDA-registered makers in 8 countries
78 establishments in 8 countries are registered with the FDA to make Vinyl Patient Examination Glove (product code LYZ, Class 1, 21 CFR 880.6250). 71 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 799 510(k) clearances under this code, the latest on April 7, 2026, and lists 5 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- LYZ
- Device class
- 1
- Regulation
- 880.6250
- Medical specialty
- General Hospital
Makers by country
| Country | Makers |
|---|---|
| China | 56 |
| United States | 11 |
| Vietnam | 5 |
| Germany | 2 |
| Indonesia | 1 |
| Canada | 1 |
| India | 1 |
| Hong Kong | 1 |
Makers of Vinyl Patient Examination 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 |
|---|---|---|---|---|---|---|---|---|
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Complaint file establishment, Specification developer | 11 | July 17, 2021 | 0 | 0 | 0 | api.fda.gov |
| Arista Latindo Industrial, Ltd. P.T. | Jakarta Barat, Indonesia | Manufacturer | 9 | July 15, 2004 | 0 | 0 | 0 | api.fda.gov |
| Ever Light Plastic Products Co., Ltd. | Shijiazhuang Hebei, China | Contract manufacturer, Manufacturer | 8 | December 18, 2014 | 0 | 0 | 0 | api.fda.gov |
| Xuzhou Full Sun Medical Products Ltd. | Pizhou Jiangsu, China | Manufacturer | 7 | July 14, 2011 | 0 | 0 | 0 | api.fda.gov |
| Grand Work Plastic Products Co., Ltd. | ZANHUANG Hebei, China | Contract manufacturer, Manufacturer | 6 | December 5, 2014 | 0 | 0 | 0 | api.fda.gov |
| Jiangsu Cureguard Glove Co., Ltd. | Ulanqab City Inner Mongolia, China | Complaint file establishment, Exporter to the US, Manufacturer | 6 | August 8, 2021 | 0 | 0 | 0 | api.fda.gov |
| K2 Health Products | Brooklyn, NY, United States | Specification developer | 6 | June 17, 2013 | 0 | 0 | 0 | api.fda.gov |
| Anhui Huaihai Medical Gloves Co., Ltd | Huaibei Anhui, China | Manufacturer | 4 | February 5, 2016 | 0 | 0 | 0 | api.fda.gov |
| Ansell Healthcare Products LLC | Reno, NV, United States | Manufacturer, Specification developer | 4 | January 31, 2014 | 0 | 0 | 0 | api.fda.gov |
| Hebei Handform Medical Products Co.,ltd. | Xingtai Hebei, China | Manufacturer | 4 | August 24, 2010 | 0 | 0 | 0 | api.fda.gov |
| Mexpo International, Inc. | Union City, CA, United States | Manufacturer | 4 | March 2, 2012 | 0 | 0 | 0 | api.fda.gov |
| Anhui Hongyuan Medical Products Co., Ltd. | Huaibei Anhui, China | Contract manufacturer, Manufacturer | 3 | January 7, 2014 | 0 | 0 | 0 | api.fda.gov |
| Hebei Hongtai Plastic Products Co.,ltd. | Xingtai Hebei, China | Manufacturer | 3 | February 23, 2017 | 0 | 0 | 0 | api.fda.gov |
| Novapro Co. Ltd. | Zibo Shandong, China | Exporter to the US, Manufacturer, Specification developer | 3 | August 24, 2011 | 0 | 0 | 0 | api.fda.gov |
| Pinnacle Co., Ltd | Linzi, Zibo Shandong, China | Manufacturer | 3 | February 21, 2008 | 0 | 0 | 0 | api.fda.gov |
| Shandong Blue Sail Innovation Co Ltd | WEIFANG Shandong, China | Manufacturer | 3 | August 10, 2011 | 0 | 0 | 0 | api.fda.gov |
| Shandong Zhanpeng Medical Products Company Limited | Qingzhou Shandong, China | Manufacturer | 3 | February 5, 2016 | 0 | 0 | 0 | api.fda.gov |
| Shandong Zhiyuan Medical Product Co Ltd | Qingzhou Shandong, China | Manufacturer | 3 | February 5, 2016 | 0 | 0 | 0 | api.fda.gov |
| Shenyi Shandong Plastic Products Co Ltd | Linzi Shandong, China | Contract manufacturer, Manufacturer | 3 | March 25, 2015 | 0 | 0 | 0 | api.fda.gov |
| Shijiazhuang Wally Plastic Co.,ltd | Shijiazhuang Hebei, China | Manufacturer | 3 | January 30, 2014 | 0 | 0 | 0 | api.fda.gov |
| Yinghua Medical Products Co., Ltd. | huaibei Anhui, China | Manufacturer | 3 | June 27, 2017 | 0 | 0 | 0 | api.fda.gov |
| Zibo Sinocare Plastic Products Co., Ltd. | ZIBO Shandong, China | Manufacturer | 3 | July 15, 2005 | 0 | 0 | 0 | api.fda.gov |
| Zibo Intco Medical Products Company Limited | Zibo Shandong, China | Exporter to the US, Manufacturer | 3 | May 1, 2014 | 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 | 2 | October 3, 2018 | 0 | 0 | 0 | api.fda.gov |
| Anhui Intco Medical Products Co., Ltd. | Huaibei Anhui, China | Contract manufacturer, Manufacturer | 2 | July 22, 2019 | 0 | 0 | 0 | api.fda.gov |
| Ever Global (vietnam) Enterprise Corporation | An Phuoc Village Dong Nai, Vietnam | Contract manufacturer, Manufacturer | 2 | February 6, 2023 | 0 | 0 | 0 | api.fda.gov |
| Hans Hepp GMBH & Co. KG | HAMBURG Lower Saxony, Germany | Manufacturer, Repackager or relabeler | 2 | May 16, 2017 | 0 | 0 | 0 | api.fda.gov |
| Inmed Gloves Factory | WEIFANG Shandong, China | Exporter to the US, Manufacturer, Specification developer | 2 | September 21, 2011 | 0 | 0 | 0 | api.fda.gov |
| Inpro Technology Device Factory | WEIFANG Shandong, China | Manufacturer | 2 | June 23, 2016 | 0 | 0 | 0 | api.fda.gov |
| Primus Gloves Private Ltd. | Kakkanad, Cochin, Kerala, India | Specification developer | 2 | October 23, 2017 | 0 | 0 | 0 | api.fda.gov |
| Shandong Huayue Glove Co., Ltd. | Zibo Shandong, China | Manufacturer | 2 | May 18, 2009 | 0 | 0 | 0 | api.fda.gov |
| Shanxi Hongjin Plastic Technology Co., Ltd | Linfen Shanxi, China | Contract manufacturer, Manufacturer | 2 | November 7, 2018 | 0 | 0 | 0 | api.fda.gov |
| True Glove Factory | Weifang Shandong, China | Manufacturer | 2 | July 6, 2011 | 0 | 0 | 0 | api.fda.gov |
| Zibo Chengxun Automatic Device Co., Ltd | Zibo Shandong, China | Exporter to the US, Specification developer | 2 | February 15, 2008 | 0 | 0 | 0 | api.fda.gov |
| Zibo Ling Yun Medical Products Co., Ltd. | Zibo Shandong, China | Manufacturer | 2 | July 9, 2015 | 0 | 0 | 0 | api.fda.gov |
| Zibo Shengkun Chemical Industry Co Ltd | Zibo Shandong, China | Contract manufacturer, Exporter to the US, Manufacturer, Specification developer | 2 | September 21, 2011 | 0 | 0 | 0 | api.fda.gov |
| Zibo Blue Sail Innovation Co., Ltd | Zibo Shandong, China | Manufacturer | 2 | November 13, 2003 | 0 | 0 | 0 | api.fda.gov |
| Alcatron Gloves Factory | Weifang Shandong, China | Manufacturer | 1 | October 27, 2011 | 0 | 0 | 0 | api.fda.gov |
| Anhui Kindguard Medical Supplies Technology Co.,ltd | Suzhou City Anhui, China | Contract manufacturer, Manufacturer | 1 | December 15, 2017 | 0 | 0 | 0 | api.fda.gov |
| Bay Medical | Brisbane, CA, United States | Specification developer | 1 | February 8, 2007 | 0 | 0 | 0 | api.fda.gov |
| Curon Scientific Co Ltd | WEIFANG Shandong, China | Manufacturer | 1 | November 8, 2010 | 0 | 0 | 0 | api.fda.gov |
| Dongguan City Ruimi Gift Products Co Ltd | Dongguan Guangdong, China | Exporter to the US, Manufacturer | 1 | May 14, 2010 | 0 | 0 | 0 | api.fda.gov |
| Ever Global (vietnam) Enterprise Corporation | Dong Nai Province, Vietnam | Contract manufacturer, Manufacturer | 1 | October 19, 2022 | 0 | 0 | 0 | api.fda.gov |
| Ever Global (vietnam) Enterprise Corporation | Long Khanh City Dong Nai, Vietnam | Manufacturer | 1 | December 29, 2017 | 0 | 0 | 0 | api.fda.gov |
| Franz Kalff GMBH | Euskirchen North Rhine-Westphalia, Germany | Exporter to the US, Specification developer | 1 | October 8, 2010 | 0 | 0 | 0 | api.fda.gov |
| Hebei Astro Medical Supply Co.,ltd | Jinzhou city Hebei, China | Manufacturer | 1 | January 5, 2022 | 0 | 0 | 0 | api.fda.gov |
| Hebei Grandeast Plastic Products Co Ltd | Xingtai Hebei, China | Manufacturer | 1 | January 15, 2015 | 0 | 0 | 0 | api.fda.gov |
| Hebei Titans Hongsen Medical Technology Co.,ltd | Xingtai Hebei, China | Manufacturer | 1 | September 21, 2018 | 0 | 0 | 0 | api.fda.gov |
| Hebei Changsheng Plastic Products Co.,Ltd. | xingtai Hebei, China | Manufacturer | 1 | April 27, 2012 | 0 | 0 | 0 | api.fda.gov |
| Intco Medical International (hong Kong) Co., Limited | Hong Kong, Hong Kong | Manufacturer | 1 | May 14, 2010 | 0 | 0 | 0 | api.fda.gov |
| Jiangsu Huayuan Medical Technology Co., Ltd. | Dongtai Jiangsu, China | Contract manufacturer, Manufacturer | 1 | October 4, 2010 | 0 | 0 | 0 | api.fda.gov |
| Jiangxi Hongda Medical Equipment Group Ltd. | Nanchang Jiangxi, China | Manufacturer | 1 | July 9, 2021 | 0 | 0 | 0 | api.fda.gov |
| Jiangxi Zhonghong Pulin Medical Products Co.,ltd. | jiujiang Jiangxi, China | Exporter to the US, Manufacturer | 1 | October 6, 2018 | 0 | 0 | 0 | api.fda.gov |
| Liao Ning Shangwei Medical Products Co., Ltd | Tieling Liaoning, China | Manufacturer | 1 | December 20, 2021 | 0 | 0 | 0 | api.fda.gov |
| Lifeline First Aid LLC | Lake Oswego, OR, United States | Repackager or relabeler, Specification developer | 1 | November 13, 2003 | 0 | 0 | 0 | api.fda.gov |
| Mayer Laboratories | Berkeley, CA, United States | Repackager or relabeler, Specification developer | 1 | May 5, 1999 | 0 | 0 | 0 | api.fda.gov |
| PM Gloves, Inc. | Chino, CA, United States | Complaint file establishment, Specification developer | 1 | March 2, 2012 | 0 | 0 | 0 | api.fda.gov |
| Premier Medical Gloves Factory | Weifang Shandong, China | Manufacturer | 1 | June 16, 2011 | 0 | 0 | 0 | api.fda.gov |
| Shandong Hengya Packaging Printing Co.,ltd | Weifang Shandong, China | Exporter to the US, Specification developer | 1 | May 10, 2011 | 0 | 0 | 0 | api.fda.gov |
| Shandong Intco Medical Products Co Ltd | Qingzhou Shandong, China | Manufacturer | 1 | January 7, 2014 | 0 | 0 | 0 | api.fda.gov |
| Shandong Shangwei Medical Products Co.,ltd | HEZE CITY Shandong, China | Manufacturer | 1 | May 14, 2021 | 0 | 0 | 0 | api.fda.gov |
| Shandong Zhushi Pharmaceutical Group Co., Ltd | Heze Shandong, China | Manufacturer | 1 | February 26, 2021 | 0 | 0 | 0 | api.fda.gov |
| Shijiazhuang Hongjun Plastic Manufacture Co., Ltd. | Shijiazhuang Hebei, China | Manufacturer | 1 | July 17, 2021 | 0 | 0 | 0 | api.fda.gov |
| Sna Safehealth Solutions Inc. | Monrovia, CA, United States | Complaint file establishment, Specification developer | 1 | February 5, 2016 | 0 | 0 | 0 | api.fda.gov |
| SW Technologies Inc. | Union City, CA, United States | Manufacturer | 1 | January 8, 2004 | 0 | 0 | 0 | api.fda.gov |
| Shandong Jieshi Intelligent Technology Co., Ltd. | Heze City Shandong, China | Manufacturer | 1 | May 14, 2021 | 0 | 0 | 0 | api.fda.gov |
| Viet Phu Trade And Import Export Co., Ltd | DONG TRIEU Quang Ninh, Vietnam | Manufacturer | 1 | October 27, 2025 | 0 | 0 | 0 | api.fda.gov |
| Weifang Tailai Steel Structure Engineering Co., Ltd | Weifang Shandong, China | Exporter to the US, Specification developer | 1 | August 24, 2011 | 0 | 0 | 0 | api.fda.gov |
| Wuhan Hongjian Co., Ltd. | Wuhan Hubei, China | Manufacturer | 1 | March 25, 2023 | 0 | 0 | 0 | api.fda.gov |
| Yue Kang Anhui Medical Products Co.,ltd | huaibei Anhui, China | Contract manufacturer, Manufacturer | 1 | November 22, 2010 | 0 | 0 | 0 | api.fda.gov |
| Zhejiang Baite Medical Appliances Co., Ltd. | Huzhou City Zhejiang, China | Manufacturer, Repackager or relabeler | 1 | August 17, 2010 | 0 | 0 | 0 | api.fda.gov |
| A-1 Creative Packaging LLC | Fort Atkinson, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Copious Intl., Inc. | Heyuan, Guangdong Province, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ever Shine Plastic Technology Co., Ltd. | Shijiazhuang City Hebei, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Noval Medical Co., Ltd. | GUANGZHOU Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Opus Gloves Co.,ltd. | shanghai, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Star Investment And Trade Joint Stock Company | Bac Ninh, Vietnam | Exporter to the US, 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 |
Updated April 7, 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.