NITRILE PATIENT EXAMINATION GLOVES, POWDERED, NON-STERILE

Polymer Patient Examination Glove

RIVERSTONE RESOURCES SDN. BHD.

The following data is part of a premarket notification filed by Riverstone Resources Sdn. Bhd. with the FDA for Nitrile Patient Examination Gloves, Powdered, Non-sterile.

Pre-market Notification Details

Device IDK992558
510k NumberK992558
Device Name:NITRILE PATIENT EXAMINATION GLOVES, POWDERED, NON-STERILE
ClassificationPolymer Patient Examination Glove
Applicant RIVERSTONE RESOURCES SDN. BHD. LOT 21909, NO.5, LORONG HELAN HINDIK KEPONG BARU INDUST. EST Kepong Baru, Kuala Lumpur,  MY 52100
ContactC.m. Chong
CorrespondentC.m. Chong
RIVERSTONE RESOURCES SDN. BHD. LOT 21909, NO.5, LORONG HELAN HINDIK KEPONG BARU INDUST. EST Kepong Baru, Kuala Lumpur,  MY 52100
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-07-30
Decision Date1999-09-27

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