POWDERED, NATURAL COLOR, LATEX SURGICAL GLOVE, STERILE MODEL: MSP1

Surgeon's Gloves

BEST PUTRA GLOVES SDN BHD

The following data is part of a premarket notification filed by Best Putra Gloves Sdn Bhd with the FDA for Powdered, Natural Color, Latex Surgical Glove, Sterile Model: Msp1.

Pre-market Notification Details

Device IDK101103
510k NumberK101103
Device Name:POWDERED, NATURAL COLOR, LATEX SURGICAL GLOVE, STERILE MODEL: MSP1
ClassificationSurgeon's Gloves
Applicant BEST PUTRA GLOVES SDN BHD MOHD TAIB, KAWASAN PERINDUSTRIAN Sg Choh Rawang, Selangor,  MY 48000
ContactEffendi Tenang
CorrespondentEffendi Tenang
BEST PUTRA GLOVES SDN BHD MOHD TAIB, KAWASAN PERINDUSTRIAN Sg Choh Rawang, Selangor,  MY 48000
Product CodeKGO  
CFR Regulation Number878.4460 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-04-20
Decision Date2010-07-16

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