K250944
- 510(k) number
- K250944
- Device name
- Nitrile Powder Free Examination Glove, Blue Tested for Use with 60 Chemotherapy Drugs, Gastric Acid, Xylazine and Fentanyl
- Applicant
- Gmp Medicare Sdn. Bhd. MY
- Product code
- LZA — Polymer Patient Examination Glove
- Decision date
- 2025-04-23
- Date received
- 2025-03-28
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General Hospital
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K250944
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.