Isolation Gown AAMI Level 3

Gown, Isolation, Surgical

Kenpax International Limited

The following data is part of a premarket notification filed by Kenpax International Limited with the FDA for Isolation Gown Aami Level 3.

Pre-market Notification Details

Device IDK212504
510k NumberK212504
Device Name:Isolation Gown AAMI Level 3
ClassificationGown, Isolation, Surgical
Applicant Kenpax International Limited Flat 5, 5/F, Wing On Plaza, 62 Mody Road Tsim Sha Tsui, Kowloon Hong Kong,  CN 999077
ContactSolomon Chen
CorrespondentJoyce Yang
Shenzhen Joyantech Consulting Co., Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District Shenzhen,  CN 518100
Product CodeFYC  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-09
Decision Date2021-11-07

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