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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.

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
LYZ
Device class
1
Regulation
880.6250
Medical specialty
General Hospital

Makers by country

CountryMakers
China56
United States11
Vietnam5
Germany2
Indonesia1
Canada1
India1
Hong Kong1

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesComplaint file establishment, Specification developer11July 17, 2021000api.fda.gov
Arista Latindo Industrial, Ltd. P.T.Jakarta Barat, IndonesiaManufacturer9July 15, 2004000api.fda.gov
Ever Light Plastic Products Co., Ltd.Shijiazhuang Hebei, ChinaContract manufacturer, Manufacturer8December 18, 2014000api.fda.gov
Xuzhou Full Sun Medical Products Ltd.Pizhou Jiangsu, ChinaManufacturer7July 14, 2011000api.fda.gov
Grand Work Plastic Products Co., Ltd.ZANHUANG Hebei, ChinaContract manufacturer, Manufacturer6December 5, 2014000api.fda.gov
Jiangsu Cureguard Glove Co., Ltd.Ulanqab City Inner Mongolia, ChinaComplaint file establishment, Exporter to the US, Manufacturer6August 8, 2021000api.fda.gov
K2 Health ProductsBrooklyn, NY, United StatesSpecification developer6June 17, 2013000api.fda.gov
Anhui Huaihai Medical Gloves Co., LtdHuaibei Anhui, ChinaManufacturer4February 5, 2016000api.fda.gov
Ansell Healthcare Products LLCReno, NV, United StatesManufacturer, Specification developer4January 31, 2014000api.fda.gov
Hebei Handform Medical Products Co.,ltd.Xingtai Hebei, ChinaManufacturer4August 24, 2010000api.fda.gov
Mexpo International, Inc.Union City, CA, United StatesManufacturer4March 2, 2012000api.fda.gov
Anhui Hongyuan Medical Products Co., Ltd.Huaibei Anhui, ChinaContract manufacturer, Manufacturer3January 7, 2014000api.fda.gov
Hebei Hongtai Plastic Products Co.,ltd.Xingtai Hebei, ChinaManufacturer3February 23, 2017000api.fda.gov
Novapro Co. Ltd.Zibo Shandong, ChinaExporter to the US, Manufacturer, Specification developer3August 24, 2011000api.fda.gov
Pinnacle Co., LtdLinzi, Zibo Shandong, ChinaManufacturer3February 21, 2008000api.fda.gov
Shandong Blue Sail Innovation Co LtdWEIFANG Shandong, ChinaManufacturer3August 10, 2011000api.fda.gov
Shandong Zhanpeng Medical Products Company LimitedQingzhou Shandong, ChinaManufacturer3February 5, 2016000api.fda.gov
Shandong Zhiyuan Medical Product Co LtdQingzhou Shandong, ChinaManufacturer3February 5, 2016000api.fda.gov
Shenyi Shandong Plastic Products Co LtdLinzi Shandong, ChinaContract manufacturer, Manufacturer3March 25, 2015000api.fda.gov
Shijiazhuang Wally Plastic Co.,ltdShijiazhuang Hebei, ChinaManufacturer3January 30, 2014000api.fda.gov
Yinghua Medical Products Co., Ltd.huaibei Anhui, ChinaManufacturer3June 27, 2017000api.fda.gov
Zibo Sinocare Plastic Products Co., Ltd.ZIBO Shandong, ChinaManufacturer3July 15, 2005000api.fda.gov
Zibo Intco Medical Products Company LimitedZibo Shandong, ChinaExporter to the US, Manufacturer3May 1, 2014000api.fda.gov
AMD Medicom Inc.Pointe-Claire, Montreal Quebec, CanadaComplaint file establishment, Exporter to the US, Foreign private label distributor, Specification developer2October 3, 2018000api.fda.gov
Anhui Intco Medical Products Co., Ltd.Huaibei Anhui, ChinaContract manufacturer, Manufacturer2July 22, 2019000api.fda.gov
Ever Global (vietnam) Enterprise CorporationAn Phuoc Village Dong Nai, VietnamContract manufacturer, Manufacturer2February 6, 2023000api.fda.gov
Hans Hepp GMBH & Co. KGHAMBURG Lower Saxony, GermanyManufacturer, Repackager or relabeler2May 16, 2017000api.fda.gov
Inmed Gloves FactoryWEIFANG Shandong, ChinaExporter to the US, Manufacturer, Specification developer2September 21, 2011000api.fda.gov
Inpro Technology Device FactoryWEIFANG Shandong, ChinaManufacturer2June 23, 2016000api.fda.gov
Primus Gloves Private Ltd.Kakkanad, Cochin, Kerala, IndiaSpecification developer2October 23, 2017000api.fda.gov
Shandong Huayue Glove Co., Ltd.Zibo Shandong, ChinaManufacturer2May 18, 2009000api.fda.gov
Shanxi Hongjin Plastic Technology Co., LtdLinfen Shanxi, ChinaContract manufacturer, Manufacturer2November 7, 2018000api.fda.gov
True Glove FactoryWeifang Shandong, ChinaManufacturer2July 6, 2011000api.fda.gov
Zibo Chengxun Automatic Device Co., LtdZibo Shandong, ChinaExporter to the US, Specification developer2February 15, 2008000api.fda.gov
Zibo Ling Yun Medical Products Co., Ltd.Zibo Shandong, ChinaManufacturer2July 9, 2015000api.fda.gov
Zibo Shengkun Chemical Industry Co LtdZibo Shandong, ChinaContract manufacturer, Exporter to the US, Manufacturer, Specification developer2September 21, 2011000api.fda.gov
Zibo Blue Sail Innovation Co., LtdZibo Shandong, ChinaManufacturer2November 13, 2003000api.fda.gov
Alcatron Gloves FactoryWeifang Shandong, ChinaManufacturer1October 27, 2011000api.fda.gov
Anhui Kindguard Medical Supplies Technology Co.,ltdSuzhou City Anhui, ChinaContract manufacturer, Manufacturer1December 15, 2017000api.fda.gov
Bay MedicalBrisbane, CA, United StatesSpecification developer1February 8, 2007000api.fda.gov
Curon Scientific Co LtdWEIFANG Shandong, ChinaManufacturer1November 8, 2010000api.fda.gov
Dongguan City Ruimi Gift Products Co LtdDongguan Guangdong, ChinaExporter to the US, Manufacturer1May 14, 2010000api.fda.gov
Ever Global (vietnam) Enterprise CorporationDong Nai Province, VietnamContract manufacturer, Manufacturer1October 19, 2022000api.fda.gov
Ever Global (vietnam) Enterprise CorporationLong Khanh City Dong Nai, VietnamManufacturer1December 29, 2017000api.fda.gov
Franz Kalff GMBHEuskirchen North Rhine-Westphalia, GermanyExporter to the US, Specification developer1October 8, 2010000api.fda.gov
Hebei Astro Medical Supply Co.,ltdJinzhou city Hebei, ChinaManufacturer1January 5, 2022000api.fda.gov
Hebei Grandeast Plastic Products Co LtdXingtai Hebei, ChinaManufacturer1January 15, 2015000api.fda.gov
Hebei Titans Hongsen Medical Technology Co.,ltdXingtai Hebei, ChinaManufacturer1September 21, 2018000api.fda.gov
Hebei Changsheng Plastic Products Co.,Ltd.xingtai Hebei, ChinaManufacturer1April 27, 2012000api.fda.gov
Intco Medical International (hong Kong) Co., LimitedHong Kong, Hong KongManufacturer1May 14, 2010000api.fda.gov
Jiangsu Huayuan Medical Technology Co., Ltd.Dongtai Jiangsu, ChinaContract manufacturer, Manufacturer1October 4, 2010000api.fda.gov
Jiangxi Hongda Medical Equipment Group Ltd.Nanchang Jiangxi, ChinaManufacturer1July 9, 2021000api.fda.gov
Jiangxi Zhonghong Pulin Medical Products Co.,ltd.jiujiang Jiangxi, ChinaExporter to the US, Manufacturer1October 6, 2018000api.fda.gov
Liao Ning Shangwei Medical Products Co., LtdTieling Liaoning, ChinaManufacturer1December 20, 2021000api.fda.gov
Lifeline First Aid LLCLake Oswego, OR, United StatesRepackager or relabeler, Specification developer1November 13, 2003000api.fda.gov
Mayer LaboratoriesBerkeley, CA, United StatesRepackager or relabeler, Specification developer1May 5, 1999000api.fda.gov
PM Gloves, Inc.Chino, CA, United StatesComplaint file establishment, Specification developer1March 2, 2012000api.fda.gov
Premier Medical Gloves FactoryWeifang Shandong, ChinaManufacturer1June 16, 2011000api.fda.gov
Shandong Hengya Packaging Printing Co.,ltdWeifang Shandong, ChinaExporter to the US, Specification developer1May 10, 2011000api.fda.gov
Shandong Intco Medical Products Co LtdQingzhou Shandong, ChinaManufacturer1January 7, 2014000api.fda.gov
Shandong Shangwei Medical Products Co.,ltdHEZE CITY Shandong, ChinaManufacturer1May 14, 2021000api.fda.gov
Shandong Zhushi Pharmaceutical Group Co., LtdHeze Shandong, ChinaManufacturer1February 26, 2021000api.fda.gov
Shijiazhuang Hongjun Plastic Manufacture Co., Ltd.Shijiazhuang Hebei, ChinaManufacturer1July 17, 2021000api.fda.gov
Sna Safehealth Solutions Inc.Monrovia, CA, United StatesComplaint file establishment, Specification developer1February 5, 2016000api.fda.gov
SW Technologies Inc.Union City, CA, United StatesManufacturer1January 8, 2004000api.fda.gov
Shandong Jieshi Intelligent Technology Co., Ltd.Heze City Shandong, ChinaManufacturer1May 14, 2021000api.fda.gov
Viet Phu Trade And Import Export Co., LtdDONG TRIEU Quang Ninh, VietnamManufacturer1October 27, 2025000api.fda.gov
Weifang Tailai Steel Structure Engineering Co., LtdWeifang Shandong, ChinaExporter to the US, Specification developer1August 24, 2011000api.fda.gov
Wuhan Hongjian Co., Ltd.Wuhan Hubei, ChinaManufacturer1March 25, 2023000api.fda.gov
Yue Kang Anhui Medical Products Co.,ltdhuaibei Anhui, ChinaContract manufacturer, Manufacturer1November 22, 2010000api.fda.gov
Zhejiang Baite Medical Appliances Co., Ltd.Huzhou City Zhejiang, ChinaManufacturer, Repackager or relabeler1August 17, 2010000api.fda.gov
A-1 Creative Packaging LLCFort Atkinson, WI, United StatesContract manufacturer0000api.fda.gov
Copious Intl., Inc.Heyuan, Guangdong Province, ChinaContract manufacturer0000api.fda.gov
Ever Shine Plastic Technology Co., Ltd.Shijiazhuang City Hebei, ChinaContract manufacturer0000api.fda.gov
Guangzhou Noval Medical Co., Ltd.GUANGZHOU Guangdong, ChinaManufacturer0000api.fda.gov
Opus Gloves Co.,ltd.shanghai, ChinaContract manufacturer0000api.fda.gov
Star Investment And Trade Joint Stock CompanyBac Ninh, VietnamExporter to the US, Manufacturer0000api.fda.gov
Zhongnuo Medical Products Co.,ltd.tangshan Hebei, ChinaContract manufacturer0000api.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.