POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTA

Latex Patient Examination Glove

AMPRI RUBBERWARE INDUSTRIES SDN BHD

The following data is part of a premarket notification filed by Ampri Rubberware Industries Sdn Bhd with the FDA for Powder-free Latex Examination Glove With Protein Labeling Claim (contains 50 Micrograms Or Less Of Total Water Extracta.

Pre-market Notification Details

Device IDK990812
510k NumberK990812
Device Name:POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTA
ClassificationLatex Patient Examination Glove
Applicant AMPRI RUBBERWARE INDUSTRIES SDN BHD LOT B5 & B6, PHASE II, KAWASAN PERINDUSTRIAN MIEL Batang Kali, Selangor,  MY 44300
ContactPack Loon Tang
CorrespondentPack Loon Tang
AMPRI RUBBERWARE INDUSTRIES SDN BHD LOT B5 & B6, PHASE II, KAWASAN PERINDUSTRIAN MIEL Batang Kali, Selangor,  MY 44300
Product CodeLYY  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-03-11
Decision Date1999-05-04

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