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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 -9668
Applicant Contact William B. Smith
Correspondent
PolyConversions, Inc.
3202 Apollo Dr.
Champaign,  IL  61822 -9668
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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