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510(k) K992337

Device
BLOSSOM POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM 50 MCGM OR LESS OF TOTAL WATER EXTRACTA
Applicant
MEXPO INTL., INC.
510(k) number
K992337
Product code
FMC  
Decision
Substantially Equivalent (SESE)
Decision date
1999-08-17
Date received
1999-07-13
Regulation
880.6250
Classification name
Patient Examination Glove
Medical specialty
General Hospital
Review panel
General Hospital
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
TIM THAI
Address
2671 Mccone Ave. Hayward, CA US 94545 94545

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
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
K882583LATEX EXAM GLOVES, NON-STERILEB Und J Instruments1988-07-14

Legacy Summary#

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FDA Review#

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