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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 K212848
Device Name Sterile Latex Surgical Gloves Powder Free
Applicant
Pentavest Holdings Sdn Bhd
No. 9574-9578, Jalan PTB 2 , Kawasan Perindustrian Tangga,
Batu,  MY 76400
Applicant Contact Teng Boon Joo
Correspondent
Liberty Management Group Ltd.
75 Executive Dr. STE114
Aurora,  IL  60504
Correspondent Contact Manoj Zacharias
Regulation Number878.4460
Classification Product Code
KGO  
Date Received09/07/2021
Decision Date 12/27/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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