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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 K891182
Device Name PATIENT EXAMINATION GLOVES
Applicant
Raystar Engineering & Construction Sdn Bhd
# 4, Jalan 19/1, 46300
Petaling Jaya, Selangor
Darul Ehsan West Malaysia,  MY
Applicant Contact CHENG SAN
Correspondent
Raystar Engineering & Construction Sdn Bhd
# 4, Jalan 19/1, 46300
Petaling Jaya, Selangor
Darul Ehsan West Malaysia,  MY
Correspondent Contact CHENG SAN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/06/1989
Decision Date 11/07/1989
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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