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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K972838
Device Name POWDER-FREE NITRILE, POLY-COATED EXAMINATION GLOVE, PURPLE OR WHITE (NON-COLORED)
Applicant
Absolute Synthetic Technologies Malaysia Sdn. Bhd.
Pt 4004 Kamunting Industrial
Estate
Kamunting, Taiping, Perak,  MY 34600
Applicant Contact WOLFE BIRKIE
Correspondent
Underwriters Laboratories, Inc.
333 Pfingsten Rd.
Northbrook,  IL  60062
Regulation Number880.6250
Classification Product Code
LZA  
Date Received08/01/1997
Decision Date 08/15/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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