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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 K981133
Device Name POWDERED NITRILE EXAMINATION GLOVES
Applicant
Servicom Services Sdn Bhd
Bangunan Angkasa Raya
Suite Gh, 17th Floor
Janan Ampang, Kuala Lumpur,  MY 50450
Applicant Contact N.S. KUMAR
Correspondent
Servicom Services Sdn Bhd
Bangunan Angkasa Raya
Suite Gh, 17th Floor
Janan Ampang, Kuala Lumpur,  MY 50450
Correspondent Contact N.S. KUMAR
Regulation Number880.6250
Classification Product Code
LZA  
Date Received03/20/1998
Decision Date 06/05/1998
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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