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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection
510(k) Number K252940
Device Name VR® Personal Protective Level 3 Gown (VR Gowns)
Applicant
PolyConversions, Inc.
3202 Apollo Dr.
Champaign,  IL  61822
Applicant Contact William B. Smith
Correspondent
PolyConversions, Inc.
3202 Apollo Dr.
Champaign,  IL  61822
Correspondent Contact William B. Smith
Regulation Number878.4040
Classification Product Code
QPC  
Date Received09/15/2025
Decision Date 12/16/2025
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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