CASHMERE NON-STERILE POWDERED NITRILE EXAMINATION GLOVES BLUE AND GREEN

Polymer Patient Examination Glove

SEAL POLYMER INDUSTRIES BHD.

The following data is part of a premarket notification filed by Seal Polymer Industries Bhd. with the FDA for Cashmere Non-sterile Powdered Nitrile Examination Gloves Blue And Green.

Pre-market Notification Details

Device IDK993133
510k NumberK993133
Device Name:CASHMERE NON-STERILE POWDERED NITRILE EXAMINATION GLOVES BLUE AND GREEN
ClassificationPolymer Patient Examination Glove
Applicant SEAL POLYMER INDUSTRIES BHD. LT 72706 KAWASAN PERINDUSTRIAN BUKIT MERAH Lahat, Perak,  MY 31500
ContactChan Chin Hong
CorrespondentChan Chin Hong
SEAL POLYMER INDUSTRIES BHD. LT 72706 KAWASAN PERINDUSTRIAN BUKIT MERAH Lahat, Perak,  MY 31500
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-09-20
Decision Date1999-11-17
Summary:summary

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