SAFESKIN STERILE SURGEONS GLOVES— 510(k) K880446

Name: FDA 510(k) clearance K880446
Creator: U.S. Food and Drug Administration
Published: 1988-06-01

Substantially Equivalent

Safeskin Corp.

FDA 510(k) clearance K880446 for SAFESKIN STERILE SURGEONS GLOVES, Substantially Equivalent on 1988-06-01. Applicant: Safeskin Corp.. Device class: 1.

Clearance details

Applicant: Safeskin Corp.
Product code: Code KGO
Device class: Class 1
Regulation: 21 CFR 878.4460
Advisory panel: General, Plastic Surgery
Date received: 1988-02-02
Decision date: 1988-06-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Coral Gables, FL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.