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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 K980149
Device Name POWDERED NITRILE EXAMINATION GLOVES
Applicant
Masju Sdn. Bhd.
Plot 3, Jalan 1, Tikam Batu
Sungai Petani,  MY 08600
Applicant Contact HENG CHENG HUI
Correspondent
Tuv Product Service, Inc.
1775 Old Hwy. 8
New Brighton,  MN  55112
Correspondent Contact CAROLE STAMP
Regulation Number880.6250
Classification Product Code
LZA  
Date Received01/16/1998
Decision Date 01/29/1998
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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