Nitrile Patient Examination gloves, Powderfree, Blue color
FDA 510(k) clearance K143477 · decided 2016-04-14
Clearance details
- K-number
- K143477
- Device name
- Nitrile Patient Examination gloves, Powderfree, Blue color
- Applicant
- Primus Gloves Pvt Limited
- Decision
- Substantially Equivalent
- Date received
- 2014-12-05
- Decision date
- 2016-04-14
- Days to decision
- 496 days
- Clearance type
- Traditional
- Product code
- LZA
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Cochin, IN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.