DERMAGRIP POWDER FREE BLUE POLYMER COATED LATEX EXAMINATION GLOVE, NON-STERILE CONTAINS 50 MICROGRAM OR LESS OF TOTAL WA

Latex Patient Examination Glove

WRP SPECIALTY PRODUCTS SDN. BHD.

The following data is part of a premarket notification filed by Wrp Specialty Products Sdn. Bhd. with the FDA for Dermagrip Powder Free Blue Polymer Coated Latex Examination Glove, Non-sterile Contains 50 Microgram Or Less Of Total Wa.

Pre-market Notification Details

Device IDK003132
510k NumberK003132
Device Name:DERMAGRIP POWDER FREE BLUE POLYMER COATED LATEX EXAMINATION GLOVE, NON-STERILE CONTAINS 50 MICROGRAM OR LESS OF TOTAL WA
ClassificationLatex Patient Examination Glove
Applicant WRP SPECIALTY PRODUCTS SDN. BHD. LOT11, JL.2,KAWASAN PERUSAHAAN BANDAR BARU SLAK TINGGI Selangor Daurl Ehsan, Sepang,  MY 43900
ContactMohd Haizan Hussein
CorrespondentMohd Haizan Hussein
WRP SPECIALTY PRODUCTS SDN. BHD. LOT11, JL.2,KAWASAN PERUSAHAAN BANDAR BARU SLAK TINGGI Selangor Daurl Ehsan, Sepang,  MY 43900
Product CodeLYY  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-10-06
Decision Date2000-11-17

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