K252549
- 510(k) number
- K252549
- Device name
- Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid; Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Blue), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid
- Applicant
- Kossan International Sdn Bhd MY
- Product code
- LZA — Polymer Patient Examination Glove
- Decision date
- 2026-01-13
- Date received
- 2025-08-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- 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: K252549
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.