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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 K891448
Device Name PATIENT EXAMINATION GLOVES (LATEX)
Applicant
Naturalex Rubber Products (M) Sdn Bhd
Lot 2, Solok Hishammuddin 6
Kaw 20, Selat Klang Utara
42000 Port Klang, Selang.,  MY
Applicant Contact SOON POR
Correspondent
Naturalex Rubber Products (M) Sdn Bhd
Lot 2, Solok Hishammuddin 6
Kaw 20, Selat Klang Utara
42000 Port Klang, Selang.,  MY
Correspondent Contact SOON POR
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/15/1989
Decision Date 04/26/1989
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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