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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 K891812
Device Name PATIENT EXAM GLOVES (MFG. GETAH GAYAL)
Applicant
Mulpha Intl. Trading Corp. Bhd.
17 Jalan Semangat
46200 Petaling Jaya
Selangor, Malaysia,  MY
Applicant Contact ROSDI B MOHD.
Correspondent
Mulpha Intl. Trading Corp. Bhd.
17 Jalan Semangat
46200 Petaling Jaya
Selangor, Malaysia,  MY
Correspondent Contact ROSDI B MOHD.
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/23/1989
Decision Date 08/18/1989
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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