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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K210145
Device Name Nitrile Glove Powder Free Blue
Applicant
Changzhou Universal Medical Equipment Co., Ltd.
No 6 Xinxi Rd.
Xinbei District,  CN 213000
Applicant Contact Xiaohai Wan
Correspondent
R. Dubois Consulting, LLC
1399 Robnick Ct.
Campbell,  CA  95008
Correspondent Contact Roxanne Dubois
Regulation Number880.6250
Classification Product Code
LZA  
Date Received01/21/2021
Decision Date 04/21/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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