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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 K891640
Device Name PATIENT EXAMINATION GLOVES (LATEX)(POWDERED)
Applicant
Perusahaan Getah Asas Sdn. Bhd.
Lot 1641, Jalan Raja Lumu, Kaw
Perindustrian, Pkns Pandamaran
42000 Port Kelang, S.D.E.,  MY
Applicant Contact CHOON KWANG
Correspondent
Perusahaan Getah Asas Sdn. Bhd.
Lot 1641, Jalan Raja Lumu, Kaw
Perindustrian, Pkns Pandamaran
42000 Port Kelang, S.D.E.,  MY
Correspondent Contact CHOON KWANG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/17/1989
Decision Date 05/22/1989
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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