VINYL EXAMINATION GLOVES, POWDERED

Vinyl Patient Examination Glove

TANGSHAN TRANSOCEAN PLASTIC PRODUCTS CO.,LTD.

The following data is part of a premarket notification filed by Tangshan Transocean Plastic Products Co.,ltd. with the FDA for Vinyl Examination Gloves, Powdered.

Pre-market Notification Details

Device IDK033308
510k NumberK033308
Device Name:VINYL EXAMINATION GLOVES, POWDERED
ClassificationVinyl Patient Examination Glove
Applicant TANGSHAN TRANSOCEAN PLASTIC PRODUCTS CO.,LTD. NO. 188 BENHU ROAD LUANNAN COUNTY Tangshan City; Hebei,  CN 063500
ContactIris Yang
CorrespondentIris Yang
TANGSHAN TRANSOCEAN PLASTIC PRODUCTS CO.,LTD. NO. 188 BENHU ROAD LUANNAN COUNTY Tangshan City; Hebei,  CN 063500
Product CodeLYZ  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-10-14
Decision Date2003-12-22

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