FMC · Class I · 21 CFR 880.6250

FDA Product Code FMC: Patient Examination Glove

Leading manufacturers include Pollak (Intl.), Ltd., Safeskin Corp. and Jamar Health Products.

34
Total
34
Cleared
77d
Avg days
1977
Since

FDA 510(k) Cleared Patient Examination Glove Devices (Product Code FMC)

34 devices
1–24 of 34
Cleared Nov 26, 2004
LAGLOVE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE - BLUE COLOR)
K042618
La Glove (M) Sdn. Bhd.
General Hospital · 60d
Cleared Jan 22, 2002
POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING (<50UG/G)
K014134
Supergrade Healthcare Products Sdn. Bhd.
General Hospital · 36d
Cleared Aug 17, 1999
BLOSSOM POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM 50 MCGM OR LESS OF TOTAL WATER EXTRACTA
K992337
Mexpo Intl., Inc.
General Hospital · 35d
Cleared May 18, 1994
NITRILE RUBBER POWDER-FREE EXAMINATION GLOVE
K932404
Safeskin Corp.
General Hospital · 370d
Cleared May 18, 1994
NITRILE RUBBER EXAMINATION GLOVES (POWERED)
K932405
Safeskin Corp.
General Hospital · 370d
Cleared Jun 17, 1993
SURGICAL INSTRUMENT KIT, DISPOSABLE
K923175
Ulti-Med Intl., Inc.
General Hospital · 370d
Cleared Jul 23, 1992
COMPASEP
K920649
Wilde-USA, Inc.
General Hospital · 162d
Cleared Jan 22, 1992
GLASION VARNISH
K915376
Sci-Pharm Scientific Pharmaceutical, Inc.
General Hospital · 54d
Cleared Jan 30, 1991
LATEX GLOVE APPLICATION AND REMOVAL SYSTEM
K905127
Success Builders Intl., Inc.
General Hospital · 77d
Cleared Nov 21, 1990
PATIENT EXAMINATION GLOVE/HYPOALLERGENIC
K905109
Tactyl Technologies, Inc.
General Hospital · 8d
Cleared Sep 05, 1990
COMFIT, PATIENT EXAMINATION GLOVES
K903746
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 23d
Cleared Aug 29, 1990
PVC PATIENT EXAMINATION GLOVE
K902278
Fujian Province Jiu Zhou Group
General Hospital · 99d
Cleared Jan 31, 1989
ROCKET SEX CRIME KIT
K883805
A & A Medical, Inc.
General Hospital · 146d
Cleared Jan 18, 1989
NON-STERILE VINYL GLOVES
K885346
Daw Shin Industrial Co., Ltd.
General Hospital · 21d
Cleared Jul 21, 1988
LATEX EXAMINATION GLOVE
K882533
Sukas Export
General Hospital · 30d
Cleared Jul 14, 1988
LATEX EXAM GLOVES, NON-STERILE
K882583
B Und J Instruments
General Hospital · 22d
Cleared May 30, 1984
TPN/CVP DRESSING CHANGE KIT
K840620
Marwood Medical, Inc.
General Hospital · 106d
Cleared Jan 26, 1984
P.T.I. DRESSING CHANGE TRAYS
K833758
Packaging Technologies, Inc.
General Hospital · 92d
Cleared Aug 11, 1983
CMS 2000 SERIES TPN KITS
K831964
Currie Medical Specialties, Inc.
General Hospital · 55d
Cleared Jul 12, 1983
ORTHOPEDIC SURGICAL GLOVE
K831564
Ansell, Inc.
General Hospital · 57d
Cleared May 21, 1982
STERILE PATIENT EXAM. GLOVES
K821043
Phoenix Glove Co.
General Hospital · 37d
Cleared Apr 26, 1982
FINGER COTS
K821028
Abco Dealers, Inc.
General Hospital · 13d
Cleared Nov 12, 1980
SUTURE WOUND TRAY MILFORD WHITTINSVILLE
K802386
American Medical Disposable, Inc.
General Hospital · 41d
Cleared Oct 10, 1980
AMPCO SKIN SCRUB TRAY
K802375
Associated Medical Products Co.
General Hospital · 10d

About Product Code FMC - Regulatory Context