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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 K892981
Device Name PATIENT EXAMINATION GLOVES
Applicant
Lapoma Gloves Industries Sdn. Bhd.
15-B, Jalan Dewani, 81100
Johor Bahru, Negeri Johor
Darul Takzim, Malaysia,  MY
Applicant Contact POH KIAT
Correspondent
Lapoma Gloves Industries Sdn. Bhd.
15-B, Jalan Dewani, 81100
Johor Bahru, Negeri Johor
Darul Takzim, Malaysia,  MY
Correspondent Contact POH KIAT
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/12/1989
Decision Date 08/03/1989
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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