Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

FMC — Predicate Candidate Screening

34 FDA 510(k) clearances under this product code; the 50 most recent screened below.

38 daysmedian FDA review time

162 days90th percentile

34clearances measured

K-number	Device	Applicant	Decided	Review days
K042618	LAGLOVE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOV	La Glove (M) Sdn. Bhd.	2004-11-26	60
K014134	POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING (<50UG/G	Supergrade Healthcare Products Sdn. Bhd.	2002-01-22	36
K992337	BLOSSOM POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CO	Mexpo Intl., Inc.	1999-08-17	35
K932404	NITRILE RUBBER POWDER-FREE EXAMINATION GLOVE	Safeskin Corp.	1994-05-18	370
K932405	NITRILE RUBBER EXAMINATION GLOVES (POWERED)	Safeskin Corp.	1994-05-18	370
K923175	SURGICAL INSTRUMENT KIT, DISPOSABLE	Ulti-Med Intl., Inc.	1993-06-17	370
K920649	COMPASEP	Wilde-USA, Inc.	1992-07-23	162
K915376	GLASION VARNISH	Sci-Pharm Scientific Pharmaceutical, Inc.	1992-01-22	54
K905127	LATEX GLOVE APPLICATION AND REMOVAL SYSTEM	Success Builders Intl., Inc.	1991-01-30	77
K905109	PATIENT EXAMINATION GLOVE/HYPOALLERGENIC	Tactyl Technologies, Inc.	1990-11-21	8
K903746	COMFIT, PATIENT EXAMINATION GLOVES	Wembley Rubber Products (M) Sdn Bhd	1990-09-05	23
K902278	PVC PATIENT EXAMINATION GLOVE	Fujian Province Jiu Zhou Group	1990-08-29	99
K883805	ROCKET SEX CRIME KIT	A & A Medical, Inc.	1989-01-31	146
K885346	NON-STERILE VINYL GLOVES	Daw Shin Industrial Co., Ltd.	1989-01-18	21
K882533	LATEX EXAMINATION GLOVE	Sukas Export	1988-07-21	30
K882583	LATEX EXAM GLOVES, NON-STERILE	B Und J Instruments	1988-07-14	22
K840620	TPN/CVP DRESSING CHANGE KIT	Marwood Medical, Inc.	1984-05-30	106
K833758	P.T.I. DRESSING CHANGE TRAYS	Packaging Technologies, Inc.	1984-01-26	92
K831964	CMS 2000 SERIES TPN KITS	Currie Medical Specialties, Inc.	1983-08-11	55
K831564	ORTHOPEDIC SURGICAL GLOVE	Ansell, Inc.	1983-07-12	57
K821043	STERILE PATIENT EXAM. GLOVES	Phoenix Glove Co.	1982-05-21	37
K821028	FINGER COTS	Abco Dealers, Inc.	1982-04-26	13
K802386	SUTURE WOUND TRAY MILFORD WHITTINSVILLE	American Medical Disposable, Inc.	1980-11-12	41
K802375	AMPCO SKIN SCRUB TRAY	Associated Medical Products Co.	1980-10-10	10
K801997	EMBOSSED DISP. POLY. GLOVES #5101-03	Pollak (Intl.), Ltd.	1980-09-09	20
K801998	STERILE EXAMINATION GLOVE #5121-5126	Pollak (Intl.), Ltd.	1980-09-09	20
K791738	CUSTOM DRESSING CHANGE TRAYS	Sterile Design, Inc.	1979-10-02	33
K791805	CONPHAR EXAM. GLOVES, POLYETHYLENE	Conphar, Inc.	1979-10-01	18
K781820	GLOVES, VINYL EXAMINATION	Phoenix Glove Co.	1978-12-07	41
K781278	GLOVES, PROCEDURE	Arbrook Mfg. Corp.	1978-08-31	37
K772336	GLOVE & LATEX FINGER COTS	Jamar Health Products	1978-01-26	38
K771757	EXAM GLOVES	Jamar Health Products	1977-10-13	27
K771673	CATHETEO CARE TRAY #0242	Concord Laboratories, Inc.	1977-09-30	28
K770479	LACERATION KIT	American Hospital Supply Corp.	1977-04-29	49

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda