POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES

Vinyl Patient Examination Glove

SHIJIAZHUANG WALLY PLASTICS CO., LTD

The following data is part of a premarket notification filed by Shijiazhuang Wally Plastics Co., Ltd with the FDA for Powder Free Synthetic Vinyl Examination Gloves.

Pre-market Notification Details

Device IDK022600
510k NumberK022600
Device Name:POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES
ClassificationVinyl Patient Examination Glove
Applicant SHIJIAZHUANG WALLY PLASTICS CO., LTD 1202 S. RTE 31 Mc Henry,  IL  60050
ContactAntonio L Giaccio
CorrespondentAntonio L Giaccio
SHIJIAZHUANG WALLY PLASTICS CO., LTD 1202 S. RTE 31 Mc Henry,  IL  60050
Product CodeLYZ  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-08-05
Decision Date2002-09-16

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B754700201 K022600 000
B754700151 K022600 000
B754700101 K022600 000
B754700051 K022600 000

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