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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 K211538
Device Name Protect X Level 3 Isolation Gown
Applicant
Azac Group
17870 Castleton St.
Suite 121
City Of Industry,  CA  91748
Applicant Contact Yen Ping Shan
Correspondent
Qpm Consulting, LLC
3817 Seville Rd.
Denton,  TX  76205
Correspondent Contact Robert Seiple
Regulation Number878.4040
Classification Product Code
FYC  
Date Received05/18/2021
Decision Date 11/17/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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