Atlas FDA

FMC

34 FDA 510(k) clearances · Product code

38 daysmedian time to decision
162 days90th percentile
34clearances measured

FDA profile

Official device name
Patient Examination Glove
Device class
Class I (low risk)
Regulation
21 CFR 880.6250
Medical specialty
General Hospital
Flags
Third-party review eligible
Adverse events (MAUDE)
2009: 3 · 2010: 7 · 2014: 7 · 2015: 41 · 2016: 333 · 2017: 32
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

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
ROCKET SEX CRIME KIT (K883805)A & A Medical, Inc.1989-01-31
NON-STERILE VINYL GLOVES (K885346)Daw Shin Industrial Co., Ltd.1989-01-18
LATEX EXAMINATION GLOVE (K882533)Sukas Export1988-07-21
LATEX EXAM GLOVES, NON-STERILE (K882583)B Und J Instruments1988-07-14
TPN/CVP DRESSING CHANGE KIT (K840620)Marwood Medical, Inc.1984-05-30
P.T.I. DRESSING CHANGE TRAYS (K833758)Packaging Technologies, Inc.1984-01-26
CMS 2000 SERIES TPN KITS (K831964)Currie Medical Specialties, Inc.1983-08-11
ORTHOPEDIC SURGICAL GLOVE (K831564)Ansell, Inc.1983-07-12
STERILE PATIENT EXAM. GLOVES (K821043)Phoenix Glove Co.1982-05-21
FINGER COTS (K821028)Abco Dealers, Inc.1982-04-26
SUTURE WOUND TRAY MILFORD WHITTINSVILLE (K802386)American Medical Disposable, Inc.1980-11-12
AMPCO SKIN SCRUB TRAY (K802375)Associated Medical Products Co.1980-10-10
EMBOSSED DISP. POLY. GLOVES #5101-03 (K801997)Pollak (Intl.), Ltd.1980-09-09
STERILE EXAMINATION GLOVE #5121-5126 (K801998)Pollak (Intl.), Ltd.1980-09-09
CUSTOM DRESSING CHANGE TRAYS (K791738)Sterile Design, Inc.1979-10-02
CONPHAR EXAM. GLOVES, POLYETHYLENE (K791805)Conphar, Inc.1979-10-01
GLOVES, VINYL EXAMINATION (K781820)Phoenix Glove Co.1978-12-07
GLOVES, PROCEDURE (K781278)Arbrook Mfg. Corp.1978-08-31
GLOVE & LATEX FINGER COTS (K772336)Jamar Health Products1978-01-26
EXAM GLOVES (K771757)Jamar Health Products1977-10-13
CATHETEO CARE TRAY #0242 (K771673)Concord Laboratories, Inc.1977-09-30
LACERATION KIT (K770479)American Hospital Supply Corp.1977-04-29

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Every clearance here is in the API, with alerts when new ones post.