RICHFUL POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)

Vinyl Patient Examination Glove

SHIJIAZHUANG RICHFUL PLASTIC CO., LTD.

The following data is part of a premarket notification filed by Shijiazhuang Richful Plastic Co., Ltd. with the FDA for Richful Powder-free Vinyl Patient Examination Gloves, Clear (non-colored).

Pre-market Notification Details

Device IDK141305
510k NumberK141305
Device Name:RICHFUL POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
ClassificationVinyl Patient Examination Glove
Applicant SHIJIAZHUANG RICHFUL PLASTIC CO., LTD. ROOM 1606 BLDG 1 JIANXIANG YUAN NO. 209 BEI SI HUAN ZHONG ROAD, HAIDIAN DIS Beijing,  CN 100083
ContactChu Xiaoan
CorrespondentChu Xiaoan
SHIJIAZHUANG RICHFUL PLASTIC CO., LTD. ROOM 1606 BLDG 1 JIANXIANG YUAN NO. 209 BEI SI HUAN ZHONG ROAD, HAIDIAN DIS Beijing,  CN 100083
Product CodeLYZ  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-05-19
Decision Date2014-08-27
Summary:summary

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