Panels › General Hospital › Product code FMC · Class 1
Patient Examination Glove
Regulation 880.6250
0510(k)s in 12 months (34 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in FMC
| Company | 510(k)s | Recalls |
|---|---|---|
| Jamar Health Products | 2 | 0 |
| Phoenix Glove Co. | 2 | 0 |
| Pollak (Intl.), Ltd. | 2 | 0 |
| Safeskin Corp. | 2 | 0 |
| A & A Medical, Inc. | 1 | 0 |
| Abco Dealers, Inc. | 1 | 0 |
| American Hospital Supply Corp. | 1 | 0 |
| American Medical Disposable, Inc. | 1 | 0 |
| Ansell, Inc. | 1 | 0 |
| Arbrook Mfg. Corp. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 26, 2004 | K042618 | LAGLOVE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE - BLUE COLOR) La Glove (M) Sdn. Bhd., MY | FMC |
| Jan 22, 2002 | K014134 | POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING (<50UG/G) Supergrade Healthcare Products Sdn. Bhd. | FMC |
| Aug 17, 1999 | K992337 | BLOSSOM POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM 50 MCGM OR LESS OF TOTAL WATER EXTRACTA Mexpo Intl., Inc. | FMC |
| May 18, 1994 | K932405 | NITRILE RUBBER EXAMINATION GLOVES (POWERED) Safeskin Corp. | FMC |
| May 18, 1994 | K932404 | NITRILE RUBBER POWDER-FREE EXAMINATION GLOVE Safeskin Corp. | FMC |
| Jun 17, 1993 | K923175 | SURGICAL INSTRUMENT KIT, DISPOSABLE Ulti-Med Intl., Inc. | FMC |
| Jul 23, 1992 | K920649 | COMPASEP Wilde-USA, Inc. | FMC |
| Jan 22, 1992 | K915376 | GLASION VARNISH Sci-Pharm Scientific Pharmaceutical, Inc. | FMC |
| Jan 30, 1991 | K905127 | LATEX GLOVE APPLICATION AND REMOVAL SYSTEM Success Builders Intl., Inc. | FMC |
| Nov 21, 1990 | K905109 | PATIENT EXAMINATION GLOVE/HYPOALLERGENIC Tactyl Technologies, Inc. | FMC |
| Sep 5, 1990 | K903746 | COMFIT, PATIENT EXAMINATION GLOVES Wembley Rubber Products (M) Sdn Bhd, MY | FMC |
| Aug 29, 1990 | K902278 | PVC PATIENT EXAMINATION GLOVE Fujian Province Jiu Zhou Group | FMC |
| Jan 31, 1989 | K883805 | ROCKET SEX CRIME KIT A & A Medical, Inc. | FMC |
| Jan 18, 1989 | K885346 | NON-STERILE VINYL GLOVES Daw Shin Industrial Co., Ltd., TW | FMC |
| Jul 21, 1988 | K882533 | LATEX EXAMINATION GLOVE Sukas Export, MY | FMC |
| Jul 14, 1988 | K882583 | LATEX EXAM GLOVES, NON-STERILE B Und J Instruments | FMC |
| May 30, 1984 | K840620 | TPN/CVP DRESSING CHANGE KIT Marwood Medical, Inc. | FMC |
| Jan 26, 1984 | K833758 | P.T.I. DRESSING CHANGE TRAYS Packaging Technologies, Inc. | FMC |
| Aug 11, 1983 | K831964 | CMS 2000 SERIES TPN KITS Currie Medical Specialties, Inc. | FMC |
| Jul 12, 1983 | K831564 | ORTHOPEDIC SURGICAL GLOVE Ansell, Inc. | FMC |
| May 21, 1982 | K821043 | STERILE PATIENT EXAM. GLOVES Phoenix Glove Co. | FMC |
| Apr 26, 1982 | K821028 | FINGER COTS Abco Dealers, Inc. | FMC |
| Nov 12, 1980 | K802386 | SUTURE WOUND TRAY MILFORD WHITTINSVILLE American Medical Disposable, Inc. | FMC |
| Oct 10, 1980 | K802375 | AMPCO SKIN SCRUB TRAY Associated Medical Products Co. | FMC |
| Sep 9, 1980 | K801998 | STERILE EXAMINATION GLOVE #5121-5126 Pollak (Intl.), Ltd. | FMC |
| Sep 9, 1980 | K801997 | EMBOSSED DISP. POLY. GLOVES #5101-03 Pollak (Intl.), Ltd. | FMC |
| Oct 2, 1979 | K791738 | CUSTOM DRESSING CHANGE TRAYS Sterile Design, Inc. | FMC |
| Oct 1, 1979 | K791805 | CONPHAR EXAM. GLOVES, POLYETHYLENE Conphar, Inc. | FMC |
| Dec 7, 1978 | K781820 | GLOVES, VINYL EXAMINATION Phoenix Glove Co. | FMC |
| Aug 31, 1978 | K781278 | GLOVES, PROCEDURE Arbrook Mfg. Corp. | FMC |
| Jan 26, 1978 | K772336 | GLOVE & LATEX FINGER COTS Jamar Health Products | FMC |
| Oct 13, 1977 | K771757 | EXAM GLOVES Jamar Health Products | FMC |
| Sep 30, 1977 | K771673 | CATHETEO CARE TRAY #0242 Concord Laboratories, Inc. | FMC |
| Apr 29, 1977 | K770479 | LACERATION KIT American Hospital Supply Corp. | FMC |
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