POWDER-FREE VINYL PATIENT EXAMINATION GLOVES

Vinyl Patient Examination Glove

TANGSHAN HONGDA PLASTCI PRODUCTS CO LTD

The following data is part of a premarket notification filed by Tangshan Hongda Plastci Products Co Ltd with the FDA for Powder-free Vinyl Patient Examination Gloves.

Pre-market Notification Details

Device IDK100326
510k NumberK100326
Device Name:POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
ClassificationVinyl Patient Examination Glove
Applicant TANGSHAN HONGDA PLASTCI PRODUCTS CO LTD NO. 209 BEI SI HUAN ZHONG ROAD HAIDIAN DISTRICT Beijing,  CN 100083
ContactChu Xiaoan
CorrespondentChu Xiaoan
TANGSHAN HONGDA PLASTCI PRODUCTS CO LTD NO. 209 BEI 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 Received2010-02-04
Decision Date2010-03-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10854344002537 K100326 000
10854344002520 K100326 000
10854344002513 K100326 000
10854344002506 K100326 000
10854344002490 K100326 000
10818566012668 K100326 000
10818566012651 K100326 000
10818566012644 K100326 000
10818566012637 K100326 000

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