Medical Glove, Specialty
General Hospital · 21 CFR 880.6250
A disposable medical glove (examination or surgeons) is a device that may or may not bear a trace amount of residual powder and is intended to be worn on the hand or finger(s) for medical purposes to prevent contamination. In addition, these gloves may have specialty claims such as chemotherapy, etc.
Recent MDR events
78 adverse event reports on file
- HALYARD SKYBREEZE POWDER-FREE NITRILE EXAM GLOVES MMay 11, 2026InjuryO&m Halyard, Inc.3014421917-2026-00010
- HALYARD SKYBREEZE POWDER-FREE NITRILE EXAM GLOVES MMay 11, 2026InjuryO&m Halyard, Inc.3014421917-2026-00011
- STERLINE NITRILE-XTRAFeb 17, 2026MalfunctionO&m Halyard, Inc.MW5183844
- STERLINE NITRILE-XTRAFeb 17, 2026MalfunctionO&m Halyard, Inc.MW5183845
- STERLINE NITRILE-XTRAFeb 17, 2026MalfunctionO&m Halyard, Inc.MW5183846
- STERLINE NITRILE-XTRAFeb 17, 2026MalfunctionO&m Halyard, Inc.MW5183847
- STERLINE NITRILE-XTRAFeb 17, 2026MalfunctionO&m Halyard, Inc.MW5183848
- STERLINE NITRILE-XTRAFeb 17, 2026MalfunctionO&m Halyard, Inc.MW5183849
- HALYARD STERLING SGFeb 12, 2026MalfunctionO & M Halyard, Inc.24321283
- HALYARDJan 15, 2026MalfunctionO&m Halyard, Inc.24079013
Event type breakdown
Recalls
8 recall events for this product code
- O&M HALYARD INCOpen, ClassifiedMay 22, 2026
Halyard Purezero Ultraviolet Nitrile Exam Gloves
Nitrile Exam Glove failed to meet specifications chemical permeation performance.
Z-2230-2026 · View FDA record ↗ - SVS LLCOpen, ClassifiedJul 9, 2024
Non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between a patient and an
Firm received complaints regarding skin irritation when using the gloves, disintegration of the gloves when used with certain cleaning solutions, and mislabeled products (e.g., outer box indicating one size, but inner box indicating another size).
Z-2320-2024 · View FDA record ↗ - Ansell Healthcare Products LLCTerminatedAug 31, 2011
MICRO-TOUCH(R), S (indicating size small), NITRILE, Powder Free, Medical Examination Gloves, REF 6034301, 200 Pieces, Manufactured for: Ansell Healthcare - Ma
Gloves were inadvertently released for distribution prior to completion of testing required by the U.S. Food and Drug Administration.
Z-3114-2011 · View FDA record ↗ - Ansell Healthcare Products LLCTerminatedAug 31, 2011
MICRO-TOUCH(R), M (indicating size medium), NITRILE, Powder Free, Medical Examination Gloves, REF 6034302, 200 Pieces, Manufactured for: Ansell Healthcare - M
Gloves were inadvertently released for distribution prior to completion of testing required by the U.S. Food and Drug Administration.
Z-3115-2011 · View FDA record ↗ - Ansell Healthcare Products LLCTerminatedAug 31, 2011
MICRO-TOUCH(R), L (indicating size large), NITRILE, Powder Free, Medical Examination Gloves, REF 6034303, 200 Pieces, Manufactured for: Ansell Healthcare - Ma
Gloves were inadvertently released for distribution prior to completion of testing required by the U.S. Food and Drug Administration.
Z-3116-2011 · View FDA record ↗ - Ansell Healthcare Products LLCTerminatedAug 31, 2011
MICRO-TOUCH(R), XL (indicating size extra large), NITRILE, Powder Free, Medical Examination Gloves, REF 6034304, 200 Pieces, Manufactured for: Ansell Healthcar
Gloves were inadvertently released for distribution prior to completion of testing required by the U.S. Food and Drug Administration.
Z-3117-2011 · View FDA record ↗ - Integra Pain ManagementTerminatedSep 20, 2008
Radiation Reduction Gloves, sterile, Latex-free, Catalog No. SSR1-7.0, SSR1-7.5, SSR1-8.0, Integra Pain Management, 3395 West 1820 South, Salt Lake City, Utah 8
Radiation reduction gloves were labeled as "Latex-free", but contain natural rubber latex.
Z-2335-2008 · View FDA record ↗ - O&M HALYARD INCOpen, ClassifiedUnknown
HALYARD STERLING ZERO NITRILE POWDER-FREE EXAM GLOVES, Sizes XS, S, M, L, and XL
All lots of the glove may discolor and lose elasticity upon aging, resulting in the inability of the user to don the gloves without tearing.
Z-0317-2022 · View FDA record ↗
Registered firms
1,086 firms currently registered for this product code
Hartalega Sdn Bhd
Bestari Jaya Selangor, MY
Prestige Ameritech
North Richland Hills, TX, US
Pt. Medisafe Technologies
Kab. Deli Serdang Sumatera Utara, ID
Tekmedic (m) Sdn Bhd
MELAKA, MY
Kossan International Sdn Bhd
Shah Alam Selangor, MY
Hartalega Ngc Sdn Bhd
Sepang Selangor, MY
Central Medicare Sdn Bhd
Teluk Intan Perak, MY
Eco Medi Glove Sdn Bhd
Taiping Perak, MY
Xingyu Medical Tech Co.,ltd
Weifang City Shandong, CN
Stgt Anv
Sadao Songkhla, TH
Ksg Medicare Sdn Bhd
Tangkak Johor, MY
Medisca Inc.
Plattsburgh, NY, US
Comfort Rubber Gloves Industries Sdn Bhd
TAIPING Perak, MY
Sterigenics Us Llc
Fort Worth, TX, US
Synergy Sterilisation Rawang (m) Sdn. Bhd.
Rawang Selangor, MY
Yty Acheh
Sitiawan Perak, MY
Eco Medi Glove Sdn Bhd
Taiping Perak, MY
Mainline Medical Dental Supply
North York Ontario, CA
O&m Halyard, Inc.
Alpharetta, GA, US
New Era Medicare Sdn Bhd
Teluk Intan Perak, MY
Vanda Glove
Pahtong, Hat Yai Songkhla, TH
North Coast Medical, Inc.
Morgan Hill, CA, US
510(k) clearances
79 clearances for this product code
- CardinalhealthJan 14, 2026
K252313 · Cardinal Health Nitrile Examination Gloves Extended Cuff
- Lingshi Hongruida Health Protection Technology Co., Ltd.Feb 24, 2025
K243959 · Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Select Other Drugs
- Jr Engineering & Medical Technologies (M) Sdn. Bhd.Aug 30, 2022
K221157 · JR Medic
- Better Care Plastic Technology Co., Ltd.Aug 27, 2022
K222449 · Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue)
- Hl Rubber Industries Sdn BhdMay 26, 2022
K220545 · Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy Drugs
- Hainan Asther Medical Equipment Co., Ltd.May 14, 2022
K220491 · Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy Drugs
- Niujian Technology Co., Ltd.Mar 31, 2022
K220353 · Disposal Medical Nitrile Examination Gloves-Tested for Use with Chemotherapy Drugs
- Changzhou Universal Medical Equipment Co., Ltd.Mar 10, 2022
K213910 · Disposable Medical Nitrile Examination Gloves- Tested for Use with Chemotherapy Drugs