510(k) clearance
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
- 510(k) number
- K262542
- Applicant
- Top Glove Sdn. Bhd.
- Decision date
- Sep 9, 2026
- Date received
- Jul 23, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Product code
- LZA
- Device type
- Polymer Patient Examination Glove
- Device class
- Class I
- Regulation
- 21 CFR 880.6250
- Advisory committee
- General Hospital
- Statement or summary
- Statement
- Third party
- N
- Location
- Klang, MY