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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 K222298
Device Name Violet Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for Use With Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl In Gastric Acid
Applicant
Onetexx Sdn Bhd
No 73-86, Jln Logam 5, Perindustrian Kmntg 3
Kmntg Raya Ind Estate
Kamunting,  MY 34600
Applicant Contact Freddy Low
Correspondent
Truscott Medsci Associates, LLC
180 Burkemeade Ct.
Roswell,  GA  30075
Correspondent Contact Wava Truscott
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Codes
LZC   OPJ   QDO  
Date Received08/01/2022
Decision Date 10/18/2022
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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