Vinyl Patient Examination Glove
General Hospital · 21 CFR 880.6250
A vinyl patient examination glove is a disposable device made of poly(vinyl chloride) that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
Recent MDR events
211 adverse event reports on file
- MEDLINEJul 30, 2026MalfunctionMedline Industries, Lp1417592-2026-12000
- MEDLINEJul 28, 2026MalfunctionMedline Industries, Lp1417592-2026-11391
- AccutouchJul 27, 2026MalfunctionMedline Industries, Lp1417592-2026-07890
- WALMARTJul 22, 2026MalfunctionMedline Industries, Lp1417592-2026-07541
- MEDLINEJul 20, 2026MalfunctionMedline Industries, Lp1417592-2026-06970
- MEDLINEJul 17, 2026MalfunctionMedline Industries, Lp1417592-2026-06652
- MEDLINEJul 14, 2026MalfunctionMedline Industries, Lp1417592-2026-05484
- MEDLINEJul 1, 2026MalfunctionMedline Industried Lp1417592-2026-03776
- CURADJun 23, 2026MalfunctionMedline Industried Lp1417592-2026-02921
- MEDLINEJun 22, 2026MalfunctionMedline Industried Lp1417592-2026-02913
Event type breakdown
Recalls
7 recall events for this product code
- CYPRESS MEDICAL PRODUCTSTerminatedDec 12, 2016
McKesson Powder Free Vinyl Exam Gloves Catalog numbers 14-116, 14-118, 14-120, 14-136, 14-138 and 14-140
A container of McKesson vinyl gloves that failed the FDA leak test was inadvertently distributed.
Z-0741-2017 · View FDA record ↗ - Gulf South Medical Supply IncTerminatedNov 15, 2012
Select Medical Products Vinyl Powder-Free Exam Gloves, Medium Model # 6370 and Large Model # 6371, 100 per box; 10 boxes per case.
Gulf South Medical Supply recalled their Select Medium and Large size Vinyl Exam Gloves because they were inadvertently shipped prior to U.S. Customs clearing them for sale.
Z-0295-2013 · View FDA record ↗ - Cypress Medical Products LLCTerminatedJan 11, 2012
Zee Clear Vinyl Medical Examination Gloves, Powder Free, Medium, Non-Sterile; 100 gloves per box, 10 boxes per case; Distributed by Zee Medical, Inc., Irvine, C
The gloves fail to meet the performance requirements of 21 CFR 800.20 for leakage defects.
Z-0679-2012 · View FDA record ↗ - Cypress Medical Products LLCTerminatedJan 11, 2012
Zee Clear Vinyl Medical Examination Gloves, Powder Free, Large, Non-Sterile; 100 gloves per box, 10 boxes per case; Distributed by Zee Medical, Inc., Irvine, CA
The gloves fail to meet the performance requirements of 21 CFR 800.20 for leakage defects.
Z-0680-2012 · View FDA record ↗ - Cypress Medical Products LLCTerminatedJan 11, 2012
Zee Clear Vinyl Medical Examination Gloves, Powder Free, X-Large, Non-Sterile; 100 gloves per box, 10 boxes per case; Distributed by Zee Medical, Inc., Irvine,
The gloves fail to meet the performance requirements of 21 CFR 800.20 for leakage defects.
Z-0681-2012 · View FDA record ↗ - Kimberly-Clark CorporationTerminatedMay 26, 2009
Kimberly-Clark, Synthetic Powder Free Vinyl Exam Gloves, Small, Medium and Large, 100 gloves per box, Non-Sterile, For Medical Use, Catalogue Numbers: 55031, 55
The product may contain defects/holes reducing the product's effectiveness as a barrier.
Z-1645-2009 · View FDA record ↗ - Cypress Medical Products LLCTerminatedUnknown
Powder Free Vinyl Exam Gloves, Item Nos. 14-116, 14-118
The firm is recalling one lot of McKesson Powder Free Vinyl Exam Gloves because a sample of product from that lot did not meet certain release specifications. It is possible that certain gloves from this lot may not be of medical exam quality and, therefore, may not provide an effective barrier to infectious material.
Z-2828-2018 · View FDA record ↗
Registered firms
331 firms currently registered for this product code
Blue Sail (hong Kong) Trading Limited
Harbour, HK
Ansell Canada Inc.
Cowansville Quebec, CA
Copious Intl., Inc.
HEYUAN, GUANGDONG PROVINCE, CN
Rfx+care Manufacturing Co., Ltd.
Shaoxing Zhejiang, CN
Shandong Huayue Glove Co., Ltd.
Zibo Shandong, CN
Zibo Intco Medical Products Company Limited
Zibo Shandong, CN
Copioumed International, Inc.
TAIPEI Taiwan, CN
Aso Llc
SARASOTA, FL, US
Medline Industries, Lp - Northfield
Northfield, IL, US
O&m Halyard, Inc.
Alpharetta, GA, US
Mexpo International, Inc.
Union City, CA, US
Jiangxi Zhonghong Pulin Medical Products Co.,ltd.
jiujiang Jiangxi, CN
Zhongnuo Medical Products Co.,ltd.
tangshan Hebei, CN
Pm Gloves, Inc.
CHINO, CA, US
K2 Health Products
Brooklyn, NY, US
Jiangsu Cureguard Glove Co., Ltd.
Ulanqab City Inner Mongolia, CN
Aso Americas, S. De R. L. De C. V.
JUAREZ Chihuahua, MX
Grand Work Plastic Products Co., Ltd.
ZANHUANG Hebei, CN
Anhui Hongyuan Medical Products Co., Ltd.
Huaibei Anhui, CN
Shijiazhuang Wally Plastic Co.,ltd
Shijiazhuang Hebei, CN
Anhui Intco Medical Products Co., Ltd.
Huaibei Anhui, CN
510(k) clearances
799 clearances for this product code
- Basic Medical Technology, Inc.Apr 7, 2026
K260860 · Powder Free Synthetic Vinyl Exam Gloves (Blue, Black)
- Viet Phu Trade and Import Export Co., Ltd.Oct 27, 2025
K252467 · Disposable Vinyl Examination Gloves
- Basic Medical Technology, Inc.Aug 28, 2025
K252505 · Powder-Free Vinyl Exam Gloves, clear
- Anqing Pukang Medical Technology Co., Ltd.May 20, 2024
K241252 · Disposable Vinyl Examination Gloves
- Guangdong Kingfa Sci. & Tech.Co., Ltd.Mar 25, 2023
K230046 · Vinyl examination gloves
- Ever Global (Vietnam) Enterprise CorporationFeb 6, 2023
K221980 · Disposable Powder Free Vinyl Examination Gloves, Beige/Clear
- Ever Global (Vietnam) Enterprise CorporationOct 19, 2022
K220992 · Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple
- Jiangxi Handspro Products Solutions Co., Ltd.Oct 8, 2022
K223008 · Disposable Vinyl Examination Gloves