Powder Free Nitrile Examination Glove, Non-sterile, Tested for Use with Chemotherapy Drugs, and the Opioid Fentanyl citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid (Blue)
510(k) K220215
Active
510(k)
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK220215 | Date26 Mar 2022 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LZA
- FDA applicant
- Ksg Medicare Sdn. Bhd.
- Device Class
- Class I
- Regulation
- 21 CFR Part 880.6250
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
From the manufacturer
Manufacturer's product page: Synthetic Rubber (Nitrile)