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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 K891275
Device Name PATIENT EXAMINATION GLOVES (LATEX)
Applicant
M.R. Rubber Industries Sdn. Bhd.
Lot 1, Light Industrial Area
41/4 Miles Jalan Gent Kelang
Setapak 53300 Kuala Lump,  MY
Applicant Contact KIN CHEANG
Correspondent
M.R. Rubber Industries Sdn. Bhd.
Lot 1, Light Industrial Area
41/4 Miles Jalan Gent Kelang
Setapak 53300 Kuala Lump,  MY
Correspondent Contact KIN CHEANG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/09/1989
Decision Date 07/28/1989
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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