FMC · Patient Examination Glove
General Hospital · 21 CFR 880.6250 · Class 1
Overview
| Product Code | FMC |
|---|---|
| Device Name | Patient Examination Glove |
| Regulation | 21 CFR 880.6250 |
| Device Class | Class 1 |
| Review Panel | General Hospital |
| 3rd-Party Reviewable | Yes |
Identification
A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.
Classification Rationale
Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
Recent Cleared Devices (20 of 34)
Showing 20 most recent of 34 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K042618 | LAGLOVE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE - BLUE COLOR) | La Glove (M) Sdn. Bhd. | Nov 26, 2004 | SESE |
| K014134 | POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING (<50UG/G) | Supergrade Healthcare Products Sdn. Bhd. | Jan 22, 2002 | SESE |
| K992337 | BLOSSOM POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM 50 MCGM OR LESS OF TOTAL WATER EXTRACTA | Mexpo Intl., Inc. | Aug 17, 1999 | SESE |
| K932405 | NITRILE RUBBER EXAMINATION GLOVES (POWERED) | Safeskin Corp. | May 18, 1994 | SESE |
| K932404 | NITRILE RUBBER POWDER-FREE EXAMINATION GLOVE | Safeskin Corp. | May 18, 1994 | SESE |
| K923175 | SURGICAL INSTRUMENT KIT, DISPOSABLE | Ulti-Med Intl., Inc. | Jun 17, 1993 | SESE |
| K920649 | COMPASEP | Wilde-USA, Inc. | Jul 23, 1992 | SESE |
| K915376 | GLASION VARNISH | Sci-Pharm Scientific Pharmaceutical, Inc. | Jan 22, 1992 | SESE |
| K905127 | LATEX GLOVE APPLICATION AND REMOVAL SYSTEM | Success Builders Intl., Inc. | Jan 30, 1991 | SESE |
| K905109 | PATIENT EXAMINATION GLOVE/HYPOALLERGENIC | Tactyl Technologies, Inc. | Nov 21, 1990 | SESE |
| K903746 | COMFIT, PATIENT EXAMINATION GLOVES | Wembley Rubber Products (M) Sdn Bhd | Sep 5, 1990 | SESE |
| K902278 | PVC PATIENT EXAMINATION GLOVE | Fujian Province Jiu Zhou Group | Aug 29, 1990 | SESE |
| K883805 | ROCKET SEX CRIME KIT | A & A Medical, Inc. | Jan 31, 1989 | SESE |
| K885346 | NON-STERILE VINYL GLOVES | Daw Shin Industrial Co., Ltd. | Jan 18, 1989 | SESE |
| K882533 | LATEX EXAMINATION GLOVE | Sukas Export | Jul 21, 1988 | SESE |
| K882583 | LATEX EXAM GLOVES, NON-STERILE | B Und J Instruments | Jul 14, 1988 | SESE |
| K840620 | TPN/CVP DRESSING CHANGE KIT | Marwood Medical, Inc. | May 30, 1984 | SESE |
| K833758 | P.T.I. DRESSING CHANGE TRAYS | Packaging Technologies, Inc. | Jan 26, 1984 | SESE |
| K831964 | CMS 2000 SERIES TPN KITS | Currie Medical Specialties, Inc. | Aug 11, 1983 | SESE |
| K831564 | ORTHOPEDIC SURGICAL GLOVE | Ansell, Inc. | Jul 12, 1983 | SESE |
Top Applicants
- Jamar Health Products — 2 clearances
- Phoenix Glove Co. — 2 clearances
- Pollak (Intl.), Ltd. — 2 clearances
- Safeskin Corp. — 2 clearances
- A & A Medical, Inc. — 1 clearance
