FDA 510(k) clearance · back to tracker

G-DERM POWDER-FREE SYNTHETIC SURGICAL GLOVE

Hutchinson Sante S.N.C. cleared K121335 on 2012-09-13, decision: substantially equivalent

K-number

K121335

Sponsor

Hutchinson Sante S.N.C.

Device

G-DERM POWDER-FREE SYNTHETIC SURGICAL GLOVE

Class

Class I

Decision

Substantially Equivalent

Decision date

2012-09-13

Product code

KGO

Advisory committee

General, Plastic Surgery

Medical specialty

General, Plastic Surgery

Regulation number

878.4460

Official FDA record

Open K121335on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.