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510(k) K801997

Device
EMBOSSED DISP. POLY. GLOVES #5101-03
Applicant
POLLAK (INTL.), LTD.
510(k) number
K801997
Product code
FMC  
Decision
Substantially Equivalent (SESE)
Decision date
1980-09-09
Date received
1980-08-20
Regulation
880.6250
Classification name
Patient Examination Glove
Medical specialty
General Hospital
Review panel
General Hospital
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FMC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K042618LAGLOVE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE - BLUE COLOR)La Glove (M) Sdn. Bhd.2004-11-26
K014134POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING (<50UG/G)Supergrade Healthcare Products Sdn. Bhd.2002-01-22
K992337BLOSSOM POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM 50 MCGM OR LESS OF TOTAL WATER EXTRACTAMexpo Intl., Inc.1999-08-17
K932405NITRILE RUBBER EXAMINATION GLOVES (POWERED)Safeskin Corp.1994-05-18
K932404NITRILE RUBBER POWDER-FREE EXAMINATION GLOVESafeskin Corp.1994-05-18
K923175SURGICAL INSTRUMENT KIT, DISPOSABLEUlti-Med Intl., Inc.1993-06-17
K920649COMPASEPWilde-USA, Inc.1992-07-23
K915376GLASION VARNISHSci-Pharm Scientific Pharmaceutical, Inc.1992-01-22
K905127LATEX GLOVE APPLICATION AND REMOVAL SYSTEMSuccess Builders Intl., Inc.1991-01-30
K905109PATIENT EXAMINATION GLOVE/HYPOALLERGENICTactyl Technologies, Inc.1990-11-21
K903746COMFIT, PATIENT EXAMINATION GLOVESWembley Rubber Products (M) Sdn Bhd1990-09-05
K902278PVC PATIENT EXAMINATION GLOVEFujian Province Jiu Zhou Group1990-08-29
K883805ROCKET SEX CRIME KITA & A Medical, Inc.1989-01-31
K885346NON-STERILE VINYL GLOVESDaw Shin Industrial Co., Ltd.1989-01-18
K882533LATEX EXAMINATION GLOVESukas Export1988-07-21

Legacy Summary#

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FDA Review#

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