FDA Product Code
FDA Product Code FMC — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.6250
510(k) Clearances — 34 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K042618 | LAGLOVE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE - BLUE COLOR) | La Glove (M) Sdn. Bhd. | 2004-11-26 | Traditional | PDF ↗ |
| K014134 | POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING (<50UG/G) | Supergrade Healthcare Products Sdn. Bhd. | 2002-01-22 | Traditional | PDF ↗ |
| K992337 | BLOSSOM POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM 50 MCGM OR LESS OF TOTAL WATER EXTRACTA | Mexpo Intl., Inc. | 1999-08-17 | Traditional | PDF ↗ |
| K932404 | NITRILE RUBBER POWDER-FREE EXAMINATION GLOVE | Safeskin Corp. | 1994-05-18 | Traditional | PDF ↗ |
| K932405 | NITRILE RUBBER EXAMINATION GLOVES (POWERED) | Safeskin Corp. | 1994-05-18 | Traditional | PDF ↗ |
| K923175 | SURGICAL INSTRUMENT KIT, DISPOSABLE | Ulti-Med Intl., Inc. | 1993-06-17 | Traditional | PDF ↗ |
| K920649 | COMPASEP | Wilde-USA, Inc. | 1992-07-23 | Traditional | PDF ↗ |
| K915376 | GLASION VARNISH | Sci-Pharm Scientific Pharmaceutical, Inc. | 1992-01-22 | Traditional | PDF ↗ |
| K905127 | LATEX GLOVE APPLICATION AND REMOVAL SYSTEM | Success Builders Intl., Inc. | 1991-01-30 | Traditional | PDF ↗ |
| K905109 | PATIENT EXAMINATION GLOVE/HYPOALLERGENIC | Tactyl Technologies, Inc. | 1990-11-21 | Traditional | PDF ↗ |
| K903746 | COMFIT, PATIENT EXAMINATION GLOVES | Wembley Rubber Products (M) Sdn Bhd | 1990-09-05 | Traditional | PDF ↗ |
| K902278 | PVC PATIENT EXAMINATION GLOVE | Fujian Province Jiu Zhou Group | 1990-08-29 | Traditional | PDF ↗ |
| K883805 | ROCKET SEX CRIME KIT | A & A Medical, Inc. | 1989-01-31 | Traditional | PDF ↗ |
| K885346 | NON-STERILE VINYL GLOVES | Daw Shin Industrial Co., Ltd. | 1989-01-18 | Traditional | PDF ↗ |
| K882533 | LATEX EXAMINATION GLOVE | Sukas Export | 1988-07-21 | Traditional | PDF ↗ |
| K882583 | LATEX EXAM GLOVES, NON-STERILE | B Und J Instruments | 1988-07-14 | Traditional | PDF ↗ |
| K840620 | TPN/CVP DRESSING CHANGE KIT | Marwood Medical, Inc. | 1984-05-30 | Traditional | PDF ↗ |
| K833758 | P.T.I. DRESSING CHANGE TRAYS | Packaging Technologies, Inc. | 1984-01-26 | Traditional | PDF ↗ |
| K831964 | CMS 2000 SERIES TPN KITS | Currie Medical Specialties, Inc. | 1983-08-11 | Traditional | PDF ↗ |
| K831564 | ORTHOPEDIC SURGICAL GLOVE | Ansell, Inc. | 1983-07-12 | Traditional | PDF ↗ |
| K821043 | STERILE PATIENT EXAM. GLOVES | Phoenix Glove Co. | 1982-05-21 | Traditional | PDF ↗ |
| K821028 | FINGER COTS | Abco Dealers, Inc. | 1982-04-26 | Traditional | PDF ↗ |
| K802386 | SUTURE WOUND TRAY MILFORD WHITTINSVILLE | American Medical Disposable, Inc. | 1980-11-12 | Traditional | PDF ↗ |
| K802375 | AMPCO SKIN SCRUB TRAY | Associated Medical Products Co. | 1980-10-10 | Traditional | PDF ↗ |
| K801997 | EMBOSSED DISP. POLY. GLOVES #5101-03 | Pollak (Intl.), Ltd. | 1980-09-09 | Traditional | PDF ↗ |
| K801998 | STERILE EXAMINATION GLOVE #5121-5126 | Pollak (Intl.), Ltd. | 1980-09-09 | Traditional | PDF ↗ |
| K791738 | CUSTOM DRESSING CHANGE TRAYS | Sterile Design, Inc. | 1979-10-02 | Traditional | PDF ↗ |
| K791805 | CONPHAR EXAM. GLOVES, POLYETHYLENE | Conphar, Inc. | 1979-10-01 | Traditional | PDF ↗ |
| K781820 | GLOVES, VINYL EXAMINATION | Phoenix Glove Co. | 1978-12-07 | Traditional | PDF ↗ |
| K781278 | GLOVES, PROCEDURE | Arbrook Mfg. Corp. | 1978-08-31 | Traditional | PDF ↗ |
| K772336 | GLOVE & LATEX FINGER COTS | Jamar Health Products | 1978-01-26 | Traditional | PDF ↗ |
| K771757 | EXAM GLOVES | Jamar Health Products | 1977-10-13 | Traditional | PDF ↗ |
| K771673 | CATHETEO CARE TRAY #0242 | Concord Laboratories, Inc. | 1977-09-30 | Traditional | PDF ↗ |
| K770479 | LACERATION KIT | American Hospital Supply Corp. | 1977-04-29 | Traditional | PDF ↗ |
Product code FMC · Class I · General Hospital. Data: openFDA.