NITRILE POWDER-FREE EXAMINATION GLOVES, PROBLUE, #7235 7 #7735

Polymer 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 Nitrile Powder-free Examination Gloves, Problue, #7235 7 #7735.

Pre-market Notification Details

Device IDK030207
510k NumberK030207
Device Name:NITRILE POWDER-FREE EXAMINATION GLOVES, PROBLUE, #7235 7 #7735
ClassificationPolymer 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 CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-01-21
Decision Date2003-05-02

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00819667020029 K030207 000
36971384150030 K030207 000
36971384150047 K030207 000
36971384150054 K030207 000
36971384150016 K030207 000
36930518036817 K030207 000
36930518036824 K030207 000
36930518036831 K030207 000
36930518036848 K030207 000
36930518036855 K030207 000
06930518018140 K030207 000
00819667020005 K030207 000
00819667020012 K030207 000
36971384150023 K030207 000

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