Isolation Gown (S, M, L, XL, XXL (Yellow, Blue))

Gown, Isolation, Surgical

Allmed Medical (Hubei) Protective Products Co., Ltd

The following data is part of a premarket notification filed by Allmed Medical (hubei) Protective Products Co., Ltd with the FDA for Isolation Gown (s, M, L, Xl, Xxl (yellow, Blue)).

Pre-market Notification Details

Device IDK221027
510k NumberK221027
Device Name:Isolation Gown (S, M, L, XL, XXL (Yellow, Blue))
ClassificationGown, Isolation, Surgical
Applicant Allmed Medical (Hubei) Protective Products Co., Ltd No.29 Dong Hu Road, Majiadian Town, Zhijiang City, Hubei, China Zhijiang,  CN 443299
ContactVince Tian
CorrespondentIvy Wang
Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Century Avenue Shanghai,  CN 200122
Product CodeFYC  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-04-06
Decision Date2022-08-12

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