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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 K893279
Device Name LATEX EXAMINATION GLOVES
Applicant
Safetytech Sdn. Bhd.
Lots 17496/17525, Taman Sela-
Yang Baru, 8 1/2 Milestone
Jalan Ipoh, 68100 Selang.,  MY
Applicant Contact A. K WONG
Correspondent
Safetytech Sdn. Bhd.
Lots 17496/17525, Taman Sela-
Yang Baru, 8 1/2 Milestone
Jalan Ipoh, 68100 Selang.,  MY
Correspondent Contact A. K WONG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/17/1989
Decision Date 09/11/1989
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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