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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K892782
Device Name PATIENT EXAMINATION GLOVES (LATEX)
Applicant
Chung Yang Rubber Works (M) Sdn. Bhd.
2010, Kawasan Miel, Prai Indu.
Estate, 13600 Prai, Penang
West Malaysia,  MY
Applicant Contact WING HING
Correspondent
Chung Yang Rubber Works (M) Sdn. Bhd.
2010, Kawasan Miel, Prai Indu.
Estate, 13600 Prai, Penang
West Malaysia,  MY
Correspondent Contact WING HING
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/11/1989
Decision Date 08/01/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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