Atlas FDA

FINGER COTS

FDA 510(k) clearance K821028 · decided 1982-04-26

Clearance details

K-number
K821028
Device name
FINGER COTS
Applicant
Abco Dealers, Inc.
Decision
Substantially Equivalent
Date received
1982-04-13
Decision date
1982-04-26
Days to decision
13 days
Clearance type
Traditional
Product code
FMC
Device class
1
Regulation number
880.6250
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
WI, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Abco Dealers

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
LAGLOVE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE - BLUE COLOR) (K042618)La Glove (M) Sdn. Bhd.2004-11-26
POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING (<50UG/G) (K014134)Supergrade Healthcare Products Sdn. Bhd.2002-01-22
BLOSSOM POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM 50 MCGM OR LESS OF TOTAL WATER EXTRACTA (K992337)Mexpo Intl., Inc.1999-08-17
NITRILE RUBBER POWDER-FREE EXAMINATION GLOVE (K932404)Safeskin Corp.1994-05-18
NITRILE RUBBER EXAMINATION GLOVES (POWERED) (K932405)Safeskin Corp.1994-05-18
SURGICAL INSTRUMENT KIT, DISPOSABLE (K923175)Ulti-Med Intl., Inc.1993-06-17
COMPASEP (K920649)Wilde-USA, Inc.1992-07-23
GLASION VARNISH (K915376)Sci-Pharm Scientific Pharmaceutical, Inc.1992-01-22
LATEX GLOVE APPLICATION AND REMOVAL SYSTEM (K905127)Success Builders Intl., Inc.1991-01-30
PATIENT EXAMINATION GLOVE/HYPOALLERGENIC (K905109)Tactyl Technologies, Inc.1990-11-21
COMFIT, PATIENT EXAMINATION GLOVES (K903746)Wembley Rubber Products (M) Sdn Bhd1990-09-05
PVC PATIENT EXAMINATION GLOVE (K902278)Fujian Province Jiu Zhou Group1990-08-29

Recalls involving this device

No recalls on record reference this clearance.