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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 K892948
Device Name HANDCARE PATIENT EXAMINATION GLOVES
Applicant
South Pacific Chemical Industries Sdn Bhd
Lot 247 Lorong Perusahaan 10
Prai Industrial Estate 13600
Province Wellesley, West,  MY
Applicant Contact F. C CHEAH
Correspondent
South Pacific Chemical Industries Sdn Bhd
Lot 247 Lorong Perusahaan 10
Prai Industrial Estate 13600
Province Wellesley, West,  MY
Correspondent Contact F. C CHEAH
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/12/1989
Decision Date 08/21/1989
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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