MOTEX LATEX EXAMINATION GLOVES, POWDER-FREE

Latex Patient Examination Glove

SHANGHAI MOTEX HEALTHCARE CO., LTD.

The following data is part of a premarket notification filed by Shanghai Motex Healthcare Co., Ltd. with the FDA for Motex Latex Examination Gloves, Powder-free.

Pre-market Notification Details

Device IDK020837
510k NumberK020837
Device Name:MOTEX LATEX EXAMINATION GLOVES, POWDER-FREE
ClassificationLatex Patient Examination Glove
Applicant SHANGHAI MOTEX HEALTHCARE CO., LTD. NO.6318, FANG HUANG RD, HUAXIN Qingpu, Shanghai,  CN 201708
ContactTony T.k. Cheng
CorrespondentTony T.k. Cheng
SHANGHAI MOTEX HEALTHCARE CO., LTD. NO.6318, FANG HUANG RD, HUAXIN Qingpu, Shanghai,  CN 201708
Product CodeLYY  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-03-14
Decision Date2002-12-02

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00819667020050 K020837 000
10819667020040 K020837 000
00819667020036 K020837 000

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