Disposable Vinyl Examination Glove

Vinyl Patient Examination Glove

Chifeng Huawei Medical Science&Technology Co.,Ltd.

The following data is part of a premarket notification filed by Chifeng Huawei Medical Science&technology Co.,ltd. with the FDA for Disposable Vinyl Examination Glove.

Pre-market Notification Details

Device IDK220469
510k NumberK220469
Device Name:Disposable Vinyl Examination Glove
ClassificationVinyl Patient Examination Glove
Applicant Chifeng Huawei Medical Science&Technology Co.,Ltd. No. 2-4, Second-stage Standardized Plant, Songshan (Anqing) Industrial Park Chifeng,  CN 024023
ContactLi Xiaohong
CorrespondentBoyle Wang
Shanghai Truthful Information Technology Co., Ltd. RM.1801,No.161 Lujiazui East Rd.,Pudong Shanghai,  CN 200120
Product CodeLYZ  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-02-18
Decision Date2022-06-16

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