Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue)
by Yty Industry (Manjung) Sdn. Bhd.
510(k) K162095
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 | NumberK162095 | Date2 Nov 2016 | 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- Withdrawn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
- Yty Industry (Manjung) Sdn Bhd
- Device Class
- Class I
- Regulation
- 21 CFR Part 880.6250
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent