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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 K222720
Device Name Blue Nitrile Powder Free Patient Examination Glove, Non Sterile
Applicant
Safeskin Retailing (Hk) Limited
26th Floor, Beautiful Group Tower, 77 Connaught Rd. Central
Hong Kong,  CN
Applicant Contact Alvin Ho
Correspondent
Dawa Medical, LLC
7320 NW 12th St. Suite 103
Miami,  FL  33126
Correspondent Contact Stephan Toupan
Regulation Number880.6250
Classification Product Code
LZA  
Date Received09/08/2022
Decision Date 12/03/2022
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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