Product code FMC
- Device name
- Patient Examination Glove
- Medical specialty
- General Hospital
- Device class
- 1
- Regulation number
- 880.6250
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K042618 | LAGLOVE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE - BLUE COLOR) | La Glove (M) Sdn. Bhd. | 2004-11-26 |
| K014134 | POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING ( | Supergrade Healthcare Products Sdn. Bhd. | 2002-01-22 |
| 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 |
| K932405 | NITRILE RUBBER EXAMINATION GLOVES (POWERED) | Safeskin Corp. | 1994-05-18 |
| K932404 | NITRILE RUBBER POWDER-FREE EXAMINATION GLOVE | Safeskin Corp. | 1994-05-18 |
| K923175 | SURGICAL INSTRUMENT KIT, DISPOSABLE | Ulti-Med Intl., Inc. | 1993-06-17 |
| K920649 | COMPASEP | Wilde-USA, Inc. | 1992-07-23 |
| K915376 | GLASION VARNISH | Sci-Pharm Scientific Pharmaceutical, Inc. | 1992-01-22 |
| K905127 | LATEX GLOVE APPLICATION AND REMOVAL SYSTEM | Success Builders Intl., Inc. | 1991-01-30 |
| K905109 | PATIENT EXAMINATION GLOVE/HYPOALLERGENIC | Tactyl Technologies, Inc. | 1990-11-21 |
| K903746 | COMFIT, PATIENT EXAMINATION GLOVES | Wembley Rubber Products (M) Sdn Bhd | 1990-09-05 |
| K902278 | PVC PATIENT EXAMINATION GLOVE | Fujian Province Jiu Zhou Group | 1990-08-29 |
| K883805 | ROCKET SEX CRIME KIT | A & A Medical, Inc. | 1989-01-31 |
| K885346 | NON-STERILE VINYL GLOVES | Daw Shin Industrial Co., Ltd. | 1989-01-18 |
| K882533 | LATEX EXAMINATION GLOVE | Sukas Export | 1988-07-21 |
| K882583 | LATEX EXAM GLOVES, NON-STERILE | B Und J Instruments | 1988-07-14 |
| K840620 | TPN/CVP DRESSING CHANGE KIT | Marwood Medical, Inc. | 1984-05-30 |
| K833758 | P.T.I. DRESSING CHANGE TRAYS | Packaging Technologies, Inc. | 1984-01-26 |
| K831964 | CMS 2000 SERIES TPN KITS | Currie Medical Specialties, Inc. | 1983-08-11 |
| K831564 | ORTHOPEDIC SURGICAL GLOVE | Ansell, Inc. | 1983-07-12 |
| K821043 | STERILE PATIENT EXAM. GLOVES | Phoenix Glove Co. | 1982-05-21 |
| K821028 | FINGER COTS | Abco Dealers, Inc. | 1982-04-26 |
| K802386 | SUTURE WOUND TRAY MILFORD WHITTINSVILLE | American Medical Disposable, Inc. | 1980-11-12 |
| K802375 | AMPCO SKIN SCRUB TRAY | Associated Medical Products Co. | 1980-10-10 |
| K801998 | STERILE EXAMINATION GLOVE #5121-5126 | Pollak (Intl.), Ltd. | 1980-09-09 |
| K801997 | EMBOSSED DISP. POLY. GLOVES #5101-03 | Pollak (Intl.), Ltd. | 1980-09-09 |
| K791738 | CUSTOM DRESSING CHANGE TRAYS | Sterile Design, Inc. | 1979-10-02 |
| K791805 | CONPHAR EXAM. GLOVES, POLYETHYLENE | Conphar, Inc. | 1979-10-01 |
| K781820 | GLOVES, VINYL EXAMINATION | Phoenix Glove Co. | 1978-12-07 |
| K781278 | GLOVES, PROCEDURE | Arbrook Mfg. Corp. | 1978-08-31 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 06973576425444 | ruyue | Shandong Ruyue Medical Technology Co.,Ltd | 2024-06-07 |
| 06973576425338 | ruyue | Shandong Ruyue Medical Technology Co.,Ltd | 2024-06-07 |
| 06973576425215 | ruyue | Shandong Ruyue Medical Technology Co.,Ltd | 2024-06-07 |
| 06973576425437 | ruyue | Shandong Ruyue Medical Technology Co.,Ltd | 2024-06-07 |
| 06973576425321 | ruyue | Shandong Ruyue Medical Technology Co.,Ltd | 2024-06-07 |
| 00850056091206 | CORRECT TOUCH | Ct International | 2024-01-15 |
| 00850056091176 | CORRECT TOUCH | Ct International | 2024-01-15 |
| 00850056091183 | CORRECT TOUCH | Ct International | 2024-01-15 |
| 00850056091190 | CORRECT TOUCH | Ct International | 2024-01-15 |
| 00850057303131 | CORRECT TOUCH | Ct International | 2024-01-15 |
| 00850056091213 | CORRECT TOUCH | Ct International | 2024-01-15 |
| 00850056091220 | CORRECT TOUCH | Ct International | 2024-01-15 |
| 00850057303087 | CORRECT TOUCH | Ct International | 2024-01-15 |
| 00850057303094 | CORRECT TOUCH | Ct International | 2024-01-15 |
| 00850057303100 | CORRECT TOUCH | Ct International | 2024-01-15 |
| 00850057303117 | CORRECT TOUCH | Ct International | 2024-01-15 |
| 00850057303124 | CORRECT TOUCH | Ct International | 2024-01-15 |
| 00850056091169 | CORRECT TOUCH | Ct International | 2024-01-15 |
| 00850056091152 | CORRECT TOUCH | Ct International | 2024-01-15 |
| 00860008768247 | Cool Blue™ Nitrile Gloves | Stellar Scientific, LLC | 2022-08-02 |
| 00860008768230 | Cool Blue™ Nitrile Gloves | Stellar Scientific, LLC | 2022-08-02 |
| 00860008768209 | Cool Blue™ Nitrile Gloves | Stellar Scientific, LLC | 2022-08-02 |
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| 00851772007229 | Emergency Medical Products | EMERGENCY MEDICAL PRODUCTS, INC. | 2016-09-24 |
| 00851772007212 | Emergency Medical Products | EMERGENCY MEDICAL PRODUCTS, INC. | 2016-09-24 |
| 00851772007151 | Emergency Medical Products | EMERGENCY MEDICAL PRODUCTS, INC. | 2016-09-24 |
| 00851772007120 | Emergency Medical Products | EMERGENCY MEDICAL PRODUCTS, INC. | 2016-09-24 |