BLACK NITRILE POWDER-FREE EXAMINATION GLOVES
FDA 510(k) clearance K121529 · decided 2012-07-12
Clearance details
- K-number
- K121529
- Device name
- BLACK NITRILE POWDER-FREE EXAMINATION GLOVES
- Applicant
- Northstar Healthcare Holdings
- Decision
- Substantially Equivalent
- Date received
- 2012-05-24
- Decision date
- 2012-07-12
- Days to decision
- 49 days
- Clearance type
- Traditional
- Product code
- LZA
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Hamilton, Bermuda, IE
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.