FDA.reportPublic FDA data

510(k) K014134

Device
POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING (<50UG/G)
Applicant
Supergrade Healthcare Products Sdn. Bhd.
510(k) number
K014134
Product code
FMC
Decision
Substantially Equivalent (SESE)
Decision date
2002-01-22
Date received
2001-12-17
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
Summary
Third party reviewed
N

Applicant Contact#

Contact
JANNA P TUCKER
Address
198 Ave. De La D'Emerald Sparks NV US 89434 89434

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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