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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 K222907
Device Name Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Applicant
Rmkh Glove (Cambodia) Co., Ltd.
Manhattan Special Economic Zone, Bavet Commune
Bavet City,  KH 120407
Applicant Contact Yang Clement KC
Correspondent
Abmed Service, Inc.
1312 17th St.
Suite 692
Denver,  CO  80202
Correspondent Contact Boyle Wang
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Codes
LZC   OPJ   QDO  
Date Received09/26/2022
Decision Date 01/04/2023
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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