Device type
Polymer Patient Examination Glove
Product code LZA · Class I · 21 CFR 880.6250 · General Hospital
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 510(k)s
Oct 29, 2026
K253508
Powder Free Nitrite Examination Glove, Cobalt Blue. Violet Blue and White. Non-Sterile
Vietglove Corporation
- LZA
- Class I
Oct 1, 2026
K262208
Non-sterile, Powder Free Nitrile Examination Aloe Vera Green Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid;Non-sterile, Powder Free Nitrile Examination Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid – Blue;Non-sterile, Powder Free Nitrile Examination Gloves - Pink
Yty Industry (Manjung) Sdn Bhd
- LZA
- Class I
Sep 9, 2026
K262542
Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder Free Examination Glove, Violet Blue Tested for Use With 32 Chemotherapy Drugs, Fentanyl & Gastric Acid Permeation Resistance Claim
Top Glove Sdn. Bhd.
- LZA
- Class I
Sep 9, 2026
K261793
Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color)
Maxter Healthcare, Inc.
- LZA
- Class I
Sep 8, 2026
K260312
Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim; Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric Acid
Gmp Medicare Sdn. Bhd.
- LZA
- Class I
Sep 2, 2026
K261749
Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Cardinalhealth
- LZA
- Class I
Aug 18, 2026
K260794
NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT AND UREA, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, FENTANYL CITRATE, XYLAZINE HCl, AND GASTRIC ACID. OCEAN COLOR
Kossan International Sdn Bhd
- LZA
- Class I
Recent recalls
Oct 7, 2026
Z-3289-2026
Brand Name: Performance Pro Product Name: Performance Pro Model/Catalog Number: 72-RM50601,72-RM50602, 72-RM50603,72-RM50604 Product Description: Blue Nitrile…
American Nitrile Operations Llc
- LZA
- Class II
- Ongoing
Oct 7, 2026
Z-3290-2026
Brand Name: Opportunity Flex Product Name: Opportunity Flex Model/Catalog Number: 72-50900, 72-50901, 72-50902, 72-50903, 72-50904 Product Description: Blue Ni…
American Nitrile Operations Llc
- LZA
- Class II
- Ongoing
Oct 7, 2026
Z-3291-2026
Brand Name: Opportunity Pro Product Name: Opportunity Pro Model/Catalog Number: 72-50800, 72-50801,72-50802,72-50803,72-50804 Product Description: Blue Nitrile…
American Nitrile Operations Llc
- LZA
- Class II
- Ongoing