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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 K891184
Device Name PATIENT EXAMINATION GLOVES (LATEX)
Applicant
Healthcare Gloves Sdn Bhd
Lot 11, Jalan Perusahaan 4
Batu Caves Selangor,  MY 68100
Applicant Contact KAM TOI
Correspondent
Healthcare Gloves Sdn Bhd
Lot 11, Jalan Perusahaan 4
Batu Caves Selangor,  MY 68100
Correspondent Contact KAM TOI
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/06/1989
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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