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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 K220427
Device Name White Nitrile Powder-Free Patient Examination Glove, Non Sterile
Applicant
One Glove Industrial Sdn Bhd
24, 1st Floor, Kompleks Kota Mulia, Jalan Long Jaafar,
Taiping,  MY 34000
Applicant Contact Marcus Low
Correspondent
Emergo Global Representative, LLC
2500 Bee Cave Rd., Bldg. 1 Suite 300
Austin,  TX  78746
Correspondent Contact Michael Van Der Woude
Regulation Number880.6250
Classification Product Code
LZA  
Date Received02/15/2022
Decision Date 05/10/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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