KLSE (MYR): HARTA (5168)
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Killsthebear
323 posts
Posted by Killsthebear > 2020-10-06 00:01 | Report Abuse
Device Classification Name Surgeon's Gloves
510(K) Number K201748
Device Name Latex Powder Free Surgical Glove With Protein Labelling Claim Of 50 Microgram Or Less Per Gram Of Glove And Tested For Use With Chemotherapy Drugs
Applicant
Hartalega SDN BHD
Dataran SD PJU 9
Bandar Sri Damansara, MY 52200
Applicant Contact Kuan Kam Hon
Correspondent
THIRD PARTY REVIEW GROUP, LLC
25 Independence Blvd
Warren, NJ 07059
Correspondent Contact Dave Yungvirt
Regulation Number 878.4460
Classification Product Code
KGO
Subsequent Product Code
LZC
Date Received 06/26/2020
Decision Date 10/02/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed By Third Party Yes
Combination Product No