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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
Applicant
Anqing Pukang Medical Technology Co., Ltd.
No 7 Haian Rd.
Anqing,  CN 246000
Applicant Contact Min Gao
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number880.6250
Classification Product Code
LYZ  
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
Predetermined Change
Control Plan Authorized		 No
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