SURGEONS GLOVE POWDER FREE— 510(k) K953358

Name: FDA 510(k) clearance K953358
Creator: U.S. Food and Drug Administration
Published: 1995-12-28

Substantially Equivalent

American Pro Latex, Inc.

FDA 510(k) clearance K953358 for SURGEONS GLOVE POWDER FREE, Substantially Equivalent on 1995-12-28. Applicant: American Pro Latex, Inc.. Device class: 1.

Clearance details

Applicant: American Pro Latex, Inc.
Product code: Code KGO
Device class: Class 1
Regulation: 21 CFR 878.4460
Advisory panel: General, Plastic Surgery
Date received: 1995-07-17
Decision date: 1995-12-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, 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.