510(k) clearance
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
- 510(k) number
- K260312
- Applicant
- Gmp Medicare Sdn. Bhd.
- Decision date
- Sep 8, 2026
- Date received
- Jan 30, 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
- Summary
- Third party
- N
- Location
- Klang, MY