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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Medical Glove, Specialty
510(k) Number K183149
Device Name Blue Non-Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Low Dermatitis and Fentanyl Permeation Resistance Claim
Applicant
Central Medicare Sdn Bhd
Pt 2609-2620, Bt 8, Jalan Changkat Jong
Teluk Intan,  MY 36000
Applicant Contact Muhammad Abdul Rahman
Correspondent
Central Medicare Sdn Bhd
Pt 2609-2620, Bt 8, Jalan Changkat Jong
Teluk Intan,  MY 36000
Correspondent Contact Muhammad Abdul Rahman
Regulation Number880.6250
Classification Product Code
LZC  
Subsequent Product Codes
LZA   QDO  
Date Received11/13/2018
Decision Date 07/04/2019
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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