G-DERM POWDER-FREE SYNTHETIC SURGICAL GLOVE— 510(k) K121335
Substantially EquivalentHutchinson Sante S.N.C.
FDA 510(k) clearance K121335 for G-DERM POWDER-FREE SYNTHETIC SURGICAL GLOVE, Substantially Equivalent on 2012-09-13. Applicant: Hutchinson Sante S.N.C.. Device class: 1.
Clearance details
- Applicant
- Hutchinson Sante S.N.C.
- Product code
- Code KGO
- Device class
- Class 1
- Regulation
- 21 CFR 878.4460
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Liancourt, FR
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Data sourced from openFDA. This site is unofficial and independent of the FDA.