DISPOSABLE SHOE COVER— 510(k) K913628

Substantially Equivalent

Gem Nonwovews, Inc.

FDA 510(k) clearance K913628 for DISPOSABLE SHOE COVER, Substantially Equivalent on 1991-10-04. Applicant: Gem Nonwovews, Inc.. Device class: 1.

Clearance details

Applicant: Gem Nonwovews, Inc.
Product code: Code FXP
Device class: Class 1
Regulation: 21 CFR 878.4040
Advisory panel: General, Plastic Surgery
Date received: 1991-08-15
Decision date: 1991-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Huntsville, AL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FXP

K971076 — PRIMED SHOE COVERS, PRIMED HEAD COVERS1998-01-13
K971191 — FAR-EAST SHOE COVERS1997-07-10
K970815 — CONVERTORS IMPERVIOUS SHOE COVERS1997-03-27
K961342 — SHOE COVER, NON-STERILE1996-12-30
K955835 — FLUID BARRIER BOOT KNEE & ANKLE-HIGH1996-11-19

More clearances from Gem Nonwovews, Inc.

K913700 — DISPOSABLE BOUFFANT CAP1991-10-04

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