PATIENT LATEX POLYMER COATED POWDER-FREE GLOVES, CONTAINS 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GR

Latex Patient Examination Glove

COMFORT RUBBER GLOVES INDUSTRIES SDN BHD

The following data is part of a premarket notification filed by Comfort Rubber Gloves Industries Sdn Bhd with the FDA for Patient Latex Polymer Coated Powder-free Gloves, Contains 50 Microgram Or Less Of Total Water Extractable Protein Per Gr.

Pre-market Notification Details

Device IDK002065
510k NumberK002065
Device Name:PATIENT LATEX POLYMER COATED POWDER-FREE GLOVES, CONTAINS 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GR
ClassificationLatex Patient Examination Glove
Applicant COMFORT RUBBER GLOVES INDUSTRIES SDN BHD LOT 821, JALAN MATANG Taiping, Perak Darul Ridzuan,  MY 34750
ContactChee Y Foo
CorrespondentChee Y Foo
COMFORT RUBBER GLOVES INDUSTRIES SDN BHD LOT 821, JALAN MATANG Taiping, Perak Darul Ridzuan,  MY 34750
Product CodeLYY  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-07-07
Decision Date2000-08-22

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