POWDER-FREE, VINYL PATIENT EXAMINATION GLOVES

Vinyl Patient Examination Glove

ZIBO INTCO MEDICAL PRODUCTS CO., LTD.

The following data is part of a premarket notification filed by Zibo Intco Medical Products Co., Ltd. with the FDA for Powder-free, Vinyl Patient Examination Gloves.

Pre-market Notification Details

Device IDK091942
510k NumberK091942
Device Name:POWDER-FREE, VINYL PATIENT EXAMINATION GLOVES
ClassificationVinyl Patient Examination Glove
Applicant ZIBO INTCO MEDICAL PRODUCTS CO., LTD. 12390 EAST END AVE. Chino,  CA  91710
ContactJohn Zhao
CorrespondentJohn Zhao
ZIBO INTCO MEDICAL PRODUCTS CO., LTD. 12390 EAST END AVE. Chino,  CA  91710
Product CodeLYZ  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-06-30
Decision Date2009-09-21

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