Gammex PI Breach Detect Powder Free Surgical Glove— 510(k) K171375
Substantially EquivalentAnsell Healthcare Products, LLC
FDA 510(k) clearance K171375 for Gammex PI Breach Detect Powder Free Surgical Glove, Substantially Equivalent on 2018-02-06. Applicant: Ansell Healthcare Products, LLC.
Clearance details
- Applicant
- Ansell Healthcare Products, LLC
- Product code
- Code KGO
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Iselin, NJ, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.