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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 K934721
Device Name EXTRA CARE
Applicant
Genting Sempurna Sdn. Bhd.
31200 Chemor
Perak,  MY
Applicant Contact LIEW D TONG
Correspondent
Genting Sempurna Sdn. Bhd.
31200 Chemor
Perak,  MY
Correspondent Contact LIEW D TONG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received09/30/1993
Decision Date 03/07/1994
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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