PREPOWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS)

Latex Patient Examination Glove

FLEXITECH SDN. BHD.

The following data is part of a premarket notification filed by Flexitech Sdn. Bhd. with the FDA for Prepowdered Latex Examination Gloves With Protein Content Labeling Claim (100 Micrograms Or Less).

Pre-market Notification Details

Device IDK990502
510k NumberK990502
Device Name:PREPOWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS)
ClassificationLatex Patient Examination Glove
Applicant FLEXITECH SDN. BHD. LOT 5071, BATU 5 1/2, JALAN MERU Klang, Selangor,  MY 41050
ContactKenny H. N. Liew
CorrespondentKenny H. N. Liew
FLEXITECH SDN. BHD. LOT 5071, BATU 5 1/2, JALAN MERU Klang, Selangor,  MY 41050
Product CodeLYY  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-02-17
Decision Date1999-04-02

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.