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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 K210587
Device Name Violet Nitrile Powder Free Patient Examination Glove, Non Sterile
Applicant
Onetexx Sdn Bhd
No 73-86, Jalan Logam 5, Perindustrian Kamunting 3,
Kamunting Raya Industrial Estate
Kamunting,  MY 34600
Applicant Contact Freddy Low
Correspondent
Emergo Global Representation
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 Received02/26/2021
Decision Date 06/28/2021
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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