Polymer Patient Examination Glove
General Hospital · 21 CFR 880.6250
A nitrile (or polymer) patient examination glove is a disposable device made of nitrile rubber or synthetic polymers 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
635 adverse event reports on file
- SensiCareJul 31, 2026InjuryMedline Industries, Lp1417592-2026-08109
- MEDLINEJul 31, 2026MalfunctionMedline Industries, Lp1417592-2026-12167
- MEDLINEJul 31, 2026MalfunctionMedline Industries, Lp1417592-2026-12183
- MEDLINEJul 31, 2026MalfunctionMedline Industries, Lp1417592-2026-12217
- MEDLINEJul 29, 2026MalfunctionMedline Industried Lp1417592-2026-08030
- MEDLINEJul 29, 2026MalfunctionMedline Industried Lp1417592-2026-08028
- MEDLINEJul 29, 2026MalfunctionMedline Industried Lp1417592-2026-08031
- MEDLINEJul 29, 2026MalfunctionMedline Industried Lp1417592-2026-08025
- MEDLINEJul 29, 2026MalfunctionMedline Industries, Lp1417592-2026-11576
- MEDLINEJul 29, 2026MalfunctionMedline Industries, Lp1417592-2026-11593
Event type breakdown
Recalls
7 recall events for this product code
- Halyard HealthTerminatedDec 14, 2016
Sterling Nitrile Sterile Powder Free Exam Gloves, S, Sterile.
Defects: Product may be discolored and brittle resulting in the inability of the user to don the gloves without tearing.
Z-0758-2017 · View FDA record ↗ - Cardinal HealthTerminatedUnknown
Ambitex NMD400 Nitrile Exam Gloves size medium. General Hospital and Personal use.
Ambitex Nitrile NMD400 Exam Gloves size medium on exam hold were inadvertently placed into commerce. The product was under Exam Hold because samples pulled from a shipment manufactured by the firm failed the water leak test performed by FDA as described at 21 CFR 800.20.
Z-0133-2016 · View FDA record ↗ - Cardinal Health 200, LLCTerminatedUnknown
ChemoPlus Chemo Spill Kit
Kit label states not made with natural rubber latex,however safety goggles within the kits contain natural rubber latex in the goggle strap
Z-1283-2019 · View FDA record ↗ - Cardinal Health 200, LLCTerminatedUnknown
ChemoPlus Chemo Spill Kit
Kit label states not made with natural rubber latex,however safety goggles within the kits contain natural rubber latex in the goggle strap
Z-1284-2019 · View FDA record ↗ - Cardinal Health 200, LLCTerminatedUnknown
ChemoPlus Protective Wrap-around Goggles
Kit label states not made with natural rubber latex,however safety goggles within the kits contain natural rubber latex in the goggle strap
Z-1285-2019 · View FDA record ↗ - Cardinal Health 200, LLCTerminatedUnknown
ChemoPlus Chemo Spill Kit, Home Health Kit
Kit label states not made with natural rubber latex,however safety goggles within the kits contain natural rubber latex in the goggle strap
Z-1286-2019 · View FDA record ↗ - HUBO INTERNATIONAL INCOpen, ClassifiedUnknown
VGlove NITRILE *** Protect Your Life 100 Patient examination gloves
Package labeled as nitrile gloves, contains latex gloves.
Z-1381-2021 · View FDA record ↗
Registered firms
1,943 firms currently registered for this product code
Tg Worldwide Sdn. Bhd.
Shah Alam Selangor, MY
Hartalega Sdn Bhd
Bestari Jaya Selangor, MY
Gallant Quality Sdn. Bhd.
TAIPING, PERAK, MY
Tekmedic (m) Sdn Bhd
MELAKA, MY
Better Care Plastic Technology Co., Ltd.
Shenze County Hebei, CN
Hartalega Ngc Sdn Bhd
Sepang Selangor, MY
Central Medicare Sdn Bhd
Teluk Intan Perak, MY
Eco Medi Glove Sdn Bhd
Taiping Perak, MY
Ansell Healthcare Products Llc
Reno, NV, US
Pt. Medisafe Technologies
Kab. Deli Serdang Sumatera Utara, ID
Us Health Express Corp
La Puente, CA, US
Xingyu Medical Tech Co.,ltd
Weifang City Shandong, CN
Stgt Anv
Sadao Songkhla, TH
Kossan International Sdn Bhd
Shah Alam Selangor, MY
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
Ag Marketing & Development Group Inc Dba Agmd Group
Brampton Ontario, CA
Tg Medical Sdn Bhd
KLANG Selangor, MY
Sw Technologies Inc.
UNION CITY, CA, US
Yty Industry (manjung) Sdn. Bhd.
SITIAWAN Perak, MY
Dipped Products (thailand) Ltd
AMPHUR KHUN NIENG Songkhla, TH
510(k) clearances
1,175 clearances for this product code
- O&M Halyard, Inc.Jul 21, 2026
K262014 · PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam Gloves
- Hartalega NGC Sdn. Bhd.Jul 20, 2026
K254285 · Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Aqua Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Violet Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Dark Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Dark Violet Blue
- Sw Technologies, Inc.Jun 24, 2026
K252117 · Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid Solution
- Kanglongda Vietnam Protection Technology Company LimitedJun 18, 2026
K253824 · Powder Free Nitrile Examination Gloves Non-Sterile Black
- Hartalega NGC Sdn. Bhd.Jun 17, 2026
K260867 · Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black)
- S&S Glove CorporationJun 3, 2026
K260703 · Powder Free Blue Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl;Powder Free Black Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl
- Vista Industries,, LLCJun 3, 2026
K260806 · Nitrile Disposable Examination Gloves
- Basic Medical Technology, Inc.Jan 23, 2026
K253160 · Syntex Exam Gloves