Disposable Surgical Face Mask (FM-34EE,FM-44EE)

Mask, Surgical

Qingdao Bestex Rubber & Plastic Products Co.,Ltd.

The following data is part of a premarket notification filed by Qingdao Bestex Rubber & Plastic Products Co.,ltd. with the FDA for Disposable Surgical Face Mask (fm-34ee,fm-44ee).

Pre-market Notification Details

Device IDK220597
510k NumberK220597
Device Name:Disposable Surgical Face Mask (FM-34EE,FM-44EE)
ClassificationMask, Surgical
Applicant Qingdao Bestex Rubber & Plastic Products Co.,Ltd. No.8-5 Guangzhou Road, Pingdu Qingdao,  CN 266701
ContactLucy Wang
CorrespondentIvy Wang
Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Century Avenue Shanghai,  CN 200122
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-01
Decision Date2022-05-26

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