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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gown, Isolation, Surgical
510(k) Number K212504
Device Name Isolation Gown AAMI Level 3
Applicant
Kenpax International Limited
Flat 5, 5/F, Wing On Plz., 62 Mody Rd.
Tsim Sha Tsui, Kowloon
Hong Kong,  CN 999077
Applicant Contact Solomon Chen
Correspondent
Shenzhen Joyantech Consulting Co., Ltd.
1713a, 17th Floor, Block A, Zhongguan Times Sq., Nanshan
District
Shenzhen,  CN 518100
Correspondent Contact Joyce Yang
Regulation Number878.4040
Classification Product Code
FYC  
Date Received08/09/2021
Decision Date 11/07/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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