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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 K892014
Device Name PATIENT EXAMINATION GLOVE (LATEX)
Applicant
Dipform Rubber Sdn. Bhd.
Lot 4, Jalan Halba 16/16
Shah Alam,
Selangor Darul Ehsan,  MY 40000
Applicant Contact LOH HEAN-LEONG
Correspondent
Dipform Rubber Sdn. Bhd.
Lot 4, Jalan Halba 16/16
Shah Alam,
Selangor Darul Ehsan,  MY 40000
Correspondent Contact LOH HEAN-LEONG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/30/1989
Decision Date 07/14/1989
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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