Biodegradable Nitrile Powder Free Examination Glove, Green +1 more— 510(k) K262542
Substantially EquivalentTop Glove Sdn. Bhd.
FDA 510(k) clearance K262542 for Biodegradable Nitrile Powder Free Examination Glove, Green +1 more, Substantially Equivalent on 2026-09-09. Applicant: Top Glove Sdn. Bhd.. Device class: 1.
Summary
Top Glove Sdn. Bhd. filed two Biodegradable Nitrile Powder Free Examination Gloves under product code LZA (Polymer Patient Examination Glove): a Green version, and a Violet Blue version whose name adds "Tested for Use With 32 Chemotherapy Drugs, Fentanyl & Gastric Acid Permeation Resistance Claim". The record doesn't list the drugs.
Class I, 21 CFR 880.6250. General Hospital is both the classification panel and the review panel. It was a Special 510(k), decided Substantially Equivalent.
Top Glove filed from Klang, Malaysia. The decision came 48 calendar days after receipt (July 23 to September 9, 2026).
Clearance details
- Device name as filed
- 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
- Applicant
- Top Glove 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
view all- K253508 — Powder Free Nitrite Examination Glove, Cobalt Blue. Violet Blue and White. Non-Sterile
- 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)
- K260312 — Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim +1 more
- K261749 — Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
More clearances from Top Glove Sdn. Bhd.
view all- K192111 — Biodegradable Nitrile Examination Powder Free Glove, Green
- K193150 — Latex Examination Powder Free Glove, Aloe Vera
- K172923 — Nitrile Examination Powder Free Glove, White, Black, Orange, Nitrile Examination Powder Free Gloves Tested For Use With Chemotherapy Drugs, Blue
- K171279 — Sterile Nitrile Surgical Powder Free Gloves Tested for Use with Chemotherapy Drugs and Sterile Latex Surgical Powder Free Gloves
- K122999 — POWDER FREE NITRILE EXAMINATION GLOVES, 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.