PATIENT NITRILE EXAMINATION GLOVE (LIGHTLY POWDERED)

Polymer Patient Examination Glove

SRI JOHANI SDN. BHD.

The following data is part of a premarket notification filed by Sri Johani Sdn. Bhd. with the FDA for Patient Nitrile Examination Glove (lightly Powdered).

Pre-market Notification Details

Device IDK973059
510k NumberK973059
Device Name:PATIENT NITRILE EXAMINATION GLOVE (LIGHTLY POWDERED)
ClassificationPolymer Patient Examination Glove
Applicant SRI JOHANI SDN. BHD. LOT PT 7178, BALAKONG N/V, SERI KEMBANGAN Selangor,  MY 43300
ContactLim Lee Aik
CorrespondentLim Lee Aik
SRI JOHANI SDN. BHD. LOT PT 7178, BALAKONG N/V, SERI KEMBANGAN Selangor,  MY 43300
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-08-18
Decision Date1997-11-07

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