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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Patient Examination Glove
510(k) Number K882533
Device Name LATEX EXAMINATION GLOVE
Applicant
Sukas Export
2, Lorong 16/6c, Section 16
46350 Petaling Jaya
Selangor, Malaysia,  MY
Applicant Contact AHMAD ABDULLAH
Correspondent
Sukas Export
2, Lorong 16/6c, Section 16
46350 Petaling Jaya
Selangor, Malaysia,  MY
Correspondent Contact AHMAD ABDULLAH
Regulation Number880.6250
Classification Product Code
FMC  
Date Received06/21/1988
Decision Date 07/21/1988
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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