Gammex PI Hybrid Surgical Gloves
FDA 510(k) clearance K151694 · decided 2016-03-09
Clearance details
- K-number
- K151694
- Device name
- Gammex PI Hybrid Surgical Gloves
- Applicant
- Ansell Healthcare Products, LLC
- Decision
- Substantially Equivalent
- Date received
- 2015-06-23
- Decision date
- 2016-03-09
- Days to decision
- 260 days
- Clearance type
- Traditional
- Product code
- KGO
- Device class
- 1
- Regulation number
- 878.4460
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Iselin, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.