Product Code: FMC
FDA class 1
21 CFR 880.6250
Patient Examination Glove
General Hospital
The Patient Examination Glove is a disposable glove worn by healthcare providers during patient examinations and procedures to prevent cross-contamination between the provider and patient. It is classified as FDA Class 1 (lowest risk) and is subject only to general controls. The product code is FMC, regulated under 21 CFR 880.6250 in the General Hospital specialty. This device is eligible for third-party review.
510(k)s
34
FEI Numbers
11
Registration Numbers
11
Unique Applicants
30
Years Active
28
Basic Information
- Product Code
- FMC
- Device Class
- FDA class 1
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✓
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
Loading...
Related 510(k) Clearances
This FDA classification is associated with 34 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K042618 | LAGLOVE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE - BLUE COLOR) | Nov 26, 2004 | Substantially Equivalent | LAGLOVE (M) SDN. BHD. |
| K014134 | POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING (<50UG/G) | Jan 22, 2002 | Substantially Equivalent | SUPERGRADE HEALTHCARE PRODUCTS SDN. BHD. |
| K992337 | BLOSSOM POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM 50 MCGM OR LESS OF TOTAL WATER EXTRACTA | Aug 17, 1999 | Substantially Equivalent | MEXPO INTL., INC. |
| K932405 | NITRILE RUBBER EXAMINATION GLOVES (POWERED) | May 18, 1994 | Substantially Equivalent | SAFESKIN CORP. |
| K932404 | NITRILE RUBBER POWDER-FREE EXAMINATION GLOVE | May 18, 1994 | Substantially Equivalent | SAFESKIN CORP. |
| K923175 | SURGICAL INSTRUMENT KIT, DISPOSABLE | Jun 17, 1993 | Substantially Equivalent | ULTI-MED INTL., INC. |
| K920649 | COMPASEP | Jul 23, 1992 | Substantially Equivalent | WILDE-USA, INC. |
| K915376 | GLASION VARNISH | Jan 22, 1992 | Substantially Equivalent | SCI-PHARM SCIENTIFIC PHARMACEUTICAL, INC. |
| K905127 | LATEX GLOVE APPLICATION AND REMOVAL SYSTEM | Jan 30, 1991 | Substantially Equivalent | SUCCESS BUILDERS INTL., INC. |
| K905109 | PATIENT EXAMINATION GLOVE/HYPOALLERGENIC | Nov 21, 1990 | Substantially Equivalent | TACTYL TECHNOLOGIES, INC. |
| K903746 | COMFIT, PATIENT EXAMINATION GLOVES | Sep 05, 1990 | Substantially Equivalent | WEMBLEY RUBBER PRODUCTS (M) SDN BHD |
| K902278 | PVC PATIENT EXAMINATION GLOVE | Aug 29, 1990 | Substantially Equivalent | FUJIAN PROVINCE JIU ZHOU GROUP |
| K883805 | ROCKET SEX CRIME KIT | Jan 31, 1989 | Substantially Equivalent | A & A MEDICAL, INC. |
| K885346 | NON-STERILE VINYL GLOVES | Jan 18, 1989 | Substantially Equivalent | DAW SHIN INDUSTRIAL CO., LTD. |
| K882533 | LATEX EXAMINATION GLOVE | Jul 21, 1988 | Substantially Equivalent | SUKAS EXPORT |
| K882583 | LATEX EXAM GLOVES, NON-STERILE | Jul 14, 1988 | Substantially Equivalent | B UND J INSTRUMENTS |
| K840620 | TPN/CVP DRESSING CHANGE KIT | May 30, 1984 | Substantially Equivalent | MARWOOD MEDICAL, INC. |
| K833758 | P.T.I. DRESSING CHANGE TRAYS | Jan 26, 1984 | Substantially Equivalent | PACKAGING TECHNOLOGIES, INC. |
| K831964 | CMS 2000 SERIES TPN KITS | Aug 11, 1983 | Substantially Equivalent | CURRIE MEDICAL SPECIALTIES, INC. |
| K831564 | ORTHOPEDIC SURGICAL GLOVE | Jul 12, 1983 | Substantially Equivalent | ANSELL, INC. |
| K821043 | STERILE PATIENT EXAM. GLOVES | May 21, 1982 | Substantially Equivalent | PHOENIX GLOVE CO. |
| K821028 | FINGER COTS | Apr 26, 1982 | Substantially Equivalent | ABCO DEALERS, INC. |
| K802386 | SUTURE WOUND TRAY MILFORD WHITTINSVILLE | Nov 12, 1980 | Substantially Equivalent | AMERICAN MEDICAL DISPOSABLE, INC. |
| K802375 | AMPCO SKIN SCRUB TRAY | Oct 10, 1980 | Substantially Equivalent | ASSOCIATED MEDICAL PRODUCTS CO. |
| K801998 | STERILE EXAMINATION GLOVE #5121-5126 | Sep 09, 1980 | Substantially Equivalent | POLLAK (INTL.), LTD. |
| K801997 | EMBOSSED DISP. POLY. GLOVES #5101-03 | Sep 09, 1980 | Substantially Equivalent | POLLAK (INTL.), LTD. |
| K791738 | CUSTOM DRESSING CHANGE TRAYS | Oct 02, 1979 | Substantially Equivalent | STERILE DESIGN, INC. |
| K791805 | CONPHAR EXAM. GLOVES, POLYETHYLENE | Oct 01, 1979 | Substantially Equivalent | CONPHAR, INC. |
| K781820 | GLOVES, VINYL EXAMINATION | Dec 07, 1978 | Substantially Equivalent | PHOENIX GLOVE CO. |
| K781278 | GLOVES, PROCEDURE | Aug 31, 1978 | Substantially Equivalent | ARBROOK MFG. CORP. |
| K772336 | GLOVE & LATEX FINGER COTS | Jan 26, 1978 | Substantially Equivalent | JAMAR HEALTH PRODUCTS |
| K771757 | EXAM GLOVES | Oct 13, 1977 | Substantially Equivalent | JAMAR HEALTH PRODUCTS |
| K771673 | CATHETEO CARE TRAY #0242 | Sep 30, 1977 | Substantially Equivalent | CONCORD LABORATORIES, INC. |
| K770479 | LACERATION KIT | Apr 29, 1977 | Substantially Equivalent | AMERICAN HOSPITAL SUPPLY CORP. |
FEI Numbers
This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.