Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim +1 more— 510(k) K260312
Substantially EquivalentGmp Medicare Sdn. Bhd.
FDA 510(k) clearance K260312 for Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim +1 more, Substantially Equivalent on 2026-09-08. Applicant: Gmp Medicare Sdn. Bhd.. Device class: 1.
Summary
Gmp Medicare's clearance covers two powder-free nitrile examination gloves under LZA, polymer patient examination gloves. The blue glove's name says it was tested for use with 32 chemotherapy drugs and carries a fentanyl permeation resistance claim. The violet blue glove's name lists 32 chemotherapy drugs, xylazine, fentanyl, and gastric acid.
Class I, 21 CFR 880.6250. General Hospital is both the classification panel and the review panel. It was a Special 510(k).
Gmp Medicare filed from Klang, Malaysia. The decision came 221 calendar days after receipt (January 30 to September 8, 2026).
Clearance details
- Device name as filed
- 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
- Applicant
- Gmp Medicare Sdn. Bhd.
- Product code
- Product code LZA
- Device class
- Class 1
- Regulation
- 21 CFR 880.6250
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Klang, MY
Recent devices under product code LZA
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- 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 +2 more
- K261793 — Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color)
- K262542 — Biodegradable Nitrile Powder Free Examination Glove, Green +1 more
- K261749 — Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
More clearances from Gmp Medicare Sdn. Bhd.
view all- K250944 — Nitrile Powder Free Examination Glove, Blue Tested for Use with 60 Chemotherapy Drugs, Gastric Acid, Xylazine and Fentanyl
- K202003 — Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim
- K163017 — Nitrile Blue Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs
Adverse events under product code LZA
product code LZA- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.