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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 K210588
Device Name Black 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
Onetexx Sdn Bhd
189 Burkemeade Ct.
Roswell,  GA  30075
Correspondent Contact Wava Truscott
Regulation Number880.6250
Classification Product Code
LZA  
Date Received02/26/2021
Decision Date 10/31/2021
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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