FMC · Class I · 21 CFR 880.6250

FDA Product Code FMC: Patient Examination Glove

Leading manufacturers include Safeskin Corp., Pollak (Intl.), Ltd. and Associated Medical Products Co..

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 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 Sep 05, 1990
COMFIT, PATIENT EXAMINATION GLOVES
K903746
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 23d
Cleared Jan 31, 1989
ROCKET SEX CRIME KIT
K883805
A & A Medical, Inc.
General Hospital · 146d
Cleared Jul 12, 1983
ORTHOPEDIC SURGICAL GLOVE
K831564
Ansell, Inc.
General Hospital · 57d
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
Cleared Sep 09, 1980
EMBOSSED DISP. POLY. GLOVES #5101-03
K801997
Pollak (Intl.), Ltd.
General Hospital · 20d
Cleared Sep 09, 1980
STERILE EXAMINATION GLOVE #5121-5126
K801998
Pollak (Intl.), Ltd.
General Hospital · 20d
Cleared Oct 01, 1979
CONPHAR EXAM. GLOVES, POLYETHYLENE
K791805
Conphar, Inc.
General Hospital · 18d
Cleared Sep 30, 1977
CATHETEO CARE TRAY #0242
K771673
Concord Laboratories, Inc.
General Hospital · 28d
Cleared Apr 29, 1977
LACERATION KIT
K770479
American Hospital Supply Corp.
General Hospital · 49d

About Product Code FMC - Regulatory Context