SCIPOTEX POWDER FREE SURGICAL GLOVES (BEADED)

Surgeon's Gloves

WEMBLEY RUBBER PRODUCTS (M) SDN BHD

The following data is part of a premarket notification filed by Wembley Rubber Products (m) Sdn Bhd with the FDA for Scipotex Powder Free Surgical Gloves (beaded).

Pre-market Notification Details

Device IDK943254
510k NumberK943254
Device Name:SCIPOTEX POWDER FREE SURGICAL GLOVES (BEADED)
ClassificationSurgeon's Gloves
Applicant WEMBLEY RUBBER PRODUCTS (M) SDN BHD KAWASAN PERUSAHAAN BANDAR BARU LOT 1, JALAN 3 Sepang Selangor,  MY 43900
ContactOng Ghee Chee
CorrespondentOng Ghee Chee
WEMBLEY RUBBER PRODUCTS (M) SDN BHD KAWASAN PERUSAHAAN BANDAR BARU LOT 1, JALAN 3 Sepang Selangor,  MY 43900
Product CodeKGO  
CFR Regulation Number878.4460 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-07-06
Decision Date1995-03-07

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