Brightway Brand Nitrile Examination Gloves 12”, Powder Free, [Sterling/Grey] with Chemotherapy Claim
by Brightway Holdings Sdn. Bhd.
510(k) K162186
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 | NumberK162186 | Date31 Mar 2017 | StatusActive |
Recalls
No FDA recalls found in the data synced 25 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LZC
- Device Class
- Class I
- Regulation
- 21 CFR Part 880.6250
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent