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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 K980511
Device Name NITRILE EXAMINATION GLOVES - POWDER FREE
Applicant
Influx Pacific Sdn. Bhd.
Lot 61, Jalan Usaha 9,
Air Keroh Industrial Estate
Malacca, West Malaysia,  MY 75450
Applicant Contact GAN SOONG TEE
Correspondent
Influx Pacific Sdn. Bhd.
Lot 61, Jalan Usaha 9,
Air Keroh Industrial Estate
Malacca, West Malaysia,  MY 75450
Correspondent Contact GAN SOONG TEE
Regulation Number880.6250
Classification Product Code
LZA  
Date Received02/10/1998
Decision Date 03/13/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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