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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 K220088
Device Name Powder Free Nitrile Examination Glove, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Applicant
Professional Latex Sdn Bhd
Lot 20734 & 20735, Lengkungan Perusahaan Kamunting 3/1
Kawasan Perusahaan Kamunting Raya,  MY 34600
Applicant Contact Kok Yoon Lim
Correspondent
Professional Latex Sdn Bhd
Lot 20734 & 20735, Lengkungan Perusahaan Kamunting 3/1
Kawasan Perusahaan Kamunting Raya,  MY 34600
Correspondent Contact Kok Yoon Lim
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Codes
LZC   OPJ   QDO  
Date Received01/11/2022
Decision Date 03/30/2023
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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