MOTEX POWDER-FREE SURGICAL GLOVES AND LIGHTLY POWDERED SURGICAL GLOVES

Surgeon's Gloves

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 Powder-free Surgical Gloves And Lightly Powdered Surgical Gloves.

Pre-market Notification Details

Device IDK063757
510k NumberK063757
Device Name:MOTEX POWDER-FREE SURGICAL GLOVES AND LIGHTLY POWDERED SURGICAL GLOVES
ClassificationSurgeon's Gloves
Applicant SHANGHAI MOTEX HEALTHCARE CO., LTD. NO. 58, FU CHIUN STREET Hsin Chu City,  TW 30067
ContactKe-min Jen
CorrespondentKe-min Jen
SHANGHAI MOTEX HEALTHCARE CO., LTD. NO. 58, FU CHIUN STREET Hsin Chu City,  TW 30067
Product CodeKGO  
CFR Regulation Number878.4460 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-12-19
Decision Date2007-07-27
Summary:summary

NIH GUDID Devices

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