Powder-Free Vinyl Patient Examination Gloves, Yellow Color

Vinyl Patient Examination Glove

Anhui Intco Medical Products Co. Ltd

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

Pre-market Notification Details

Device IDK191092
510k NumberK191092
Device Name:Powder-Free Vinyl Patient Examination Gloves, Yellow Color
ClassificationVinyl Patient Examination Glove
Applicant Anhui Intco Medical Products Co. Ltd No. 1 Haitang Road, Suixi District Economic Development Area Huaibei City, Anhui Huaibei,  CN 235100
ContactJacken Cai
CorrespondentDerek Tian
Intco Medical Industries, Inc. 805 Barrington Ave Ontario,  CA  91764
Product CodeLYZ  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-04-24
Decision Date2019-07-22
Summary:summary

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