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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgeon'S Gloves
510(k) Number K910895
Device Name SURGICAL GLOVES
Applicant
Influx Pacific Sdn. Bhd.
Lot 61, Jalan Usaha 9,
Air Keroh Industrial Estate
Malacca, West Malaysia,  MY 75450
Applicant Contact SOONG TEE
Correspondent
Influx Pacific Sdn. Bhd.
Lot 61, Jalan Usaha 9,
Air Keroh Industrial Estate
Malacca, West Malaysia,  MY 75450
Correspondent Contact SOONG TEE
Regulation Number878.4460
Classification Product Code
KGO  
Date Received03/04/1991
Decision Date 07/22/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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