POWDERED VINYL PATIENT EXAMINATION GLOVES, COLORED (WHITE, YELLOW)

Vinyl Patient Examination Glove

SHIJIAZHUANG MANFUL LIGHT INDUSTRIAL PRODUCTS CO.,

The following data is part of a premarket notification filed by Shijiazhuang Manful Light Industrial Products Co., with the FDA for Powdered Vinyl Patient Examination Gloves, Colored (white, Yellow).

Pre-market Notification Details

Device IDK051924
510k NumberK051924
Device Name:POWDERED VINYL PATIENT EXAMINATION GLOVES, COLORED (WHITE, YELLOW)
ClassificationVinyl Patient Examination Glove
Applicant SHIJIAZHUANG MANFUL LIGHT INDUSTRIAL PRODUCTS CO., RM 1606, BLDG 1 JIANXIANG YUAN NO 209 BIE SI HUAN ZHONG ROAD Haidian District, Beijing,  CN 100083
ContactChu Xiaoan
CorrespondentChu Xiaoan
SHIJIAZHUANG MANFUL LIGHT INDUSTRIAL PRODUCTS CO., RM 1606, BLDG 1 JIANXIANG YUAN NO 209 BIE SI HUAN ZHONG ROAD Haidian District, Beijing,  CN 100083
Product CodeLYZ  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-07-15
Decision Date2005-09-02
Summary:summary

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