FMC — Patient Examination Glove Class I
FDA product code FMC covers "Patient Examination Glove", a Class I medical device regulated under 21 CFR 880.6250. Submissions are reviewed by the General Hospital panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FMC
- Device Class
- Class I
- Regulation Number
- 880.6250
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K042618 | la glove (m) sdn. bhd | LAGLOVE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE - BL | November 26, 2004 |
| K014134 | supergrade healthcare products sdn. bhd | POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING (<50UG/G) | January 22, 2002 |
| K992337 | mexpo intl | BLOSSOM POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM | August 17, 1999 |
| K932404 | safeskin | NITRILE RUBBER POWDER-FREE EXAMINATION GLOVE | May 18, 1994 |
| K932405 | safeskin | NITRILE RUBBER EXAMINATION GLOVES (POWERED) | May 18, 1994 |
| K923175 | ulti-med intl | SURGICAL INSTRUMENT KIT, DISPOSABLE | June 17, 1993 |
| K920649 | wilde-usa | COMPASEP | July 23, 1992 |
| K915376 | sci-pharm scientific pharmaceutical | GLASION VARNISH | January 22, 1992 |
| K905127 | success builders intl | LATEX GLOVE APPLICATION AND REMOVAL SYSTEM | January 30, 1991 |
| K905109 | tactyl technologies | PATIENT EXAMINATION GLOVE/HYPOALLERGENIC | November 21, 1990 |
| K903746 | wembley rubber products (m) | COMFIT, PATIENT EXAMINATION GLOVES | September 5, 1990 |
| K902278 | fujian province jiu zhou group | PVC PATIENT EXAMINATION GLOVE | August 29, 1990 |
| K883805 | a and a medical | ROCKET SEX CRIME KIT | January 31, 1989 |
| K885346 | daw shin industrial co | NON-STERILE VINYL GLOVES | January 18, 1989 |
| K882533 | sukas export | LATEX EXAMINATION GLOVE | July 21, 1988 |
| K882583 | b und j instruments | LATEX EXAM GLOVES, NON-STERILE | July 14, 1988 |
| K840620 | marwood medical | TPN/CVP DRESSING CHANGE KIT | May 30, 1984 |
| K833758 | packaging technologies | P.T.I. DRESSING CHANGE TRAYS | January 26, 1984 |
| K831964 | currie medical specialties | CMS 2000 SERIES TPN KITS | August 11, 1983 |
| K831564 | ansell | ORTHOPEDIC SURGICAL GLOVE | July 12, 1983 |