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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name vinyl patient examination glove
510(k) Number K241252
Device Name Disposable Vinyl Examination Gloves
Anqing Pukang Medical Technology Co., LTD.
No 7 Haian Road
Anqing,  CN 246000
Applicant Contact Min Gao
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number880.6250
Classification Product Code
Date Received05/03/2024
Decision Date 05/20/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No