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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 K890965
Device Name PATIENT EXAMINATION GLOVES
Applicant
N.S. Uni-Gloves Sdn. Bhd.
Lot 3 & 4/4510 Senawang Ind.
Estate
Seremban N.S.,  MY 70450
Applicant Contact BENG TECK
Correspondent
N.S. Uni-Gloves Sdn. Bhd.
Lot 3 & 4/4510 Senawang Ind.
Estate
Seremban N.S.,  MY 70450
Correspondent Contact BENG TECK
Regulation Number880.6250
Classification Product Code
LYY  
Date Received02/27/1989
Decision Date 04/28/1989
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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