POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW)

Vinyl Patient Examination Glove

TANGSHAN KANGYUAN GLOVE CO., LTD.

The following data is part of a premarket notification filed by Tangshan Kangyuan Glove Co., Ltd. with the FDA for Powder Free Vinyl Patient Examination Gloves, Colored (yellow).

Pre-market Notification Details

Device IDK102569
510k NumberK102569
Device Name:POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW)
ClassificationVinyl Patient Examination Glove
Applicant TANGSHAN KANGYUAN GLOVE CO., LTD. RM 1606 BLDG. 1. JIANXING YUAN NO. 209 BEI SI HUAN Beijing,  CN 100083
ContactChu Xiaoan
CorrespondentChu Xiaoan
TANGSHAN KANGYUAN GLOVE CO., LTD. RM 1606 BLDG. 1. JIANXING YUAN NO. 209 BEI SI HUAN Beijing,  CN 100083
Product CodeLYZ  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-09-07
Decision Date2010-10-21
Summary:summary

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