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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 K212408
Device Name Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs Use and Simulated Gastric Acid)
Applicant
Pt. Maja Agung Latexindo
Jl. Utama # 98, Pujimulyo
Sunggal, Deli Serdang,  ID 20352
Applicant Contact Sivaprakash S
Correspondent
Shamrock Marketing Co., Inc.
5445 Daniels St.
Chino,  CA  91710
Correspondent Contact Jeni Chuason
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Code
LZC  
Date Received08/03/2021
Decision Date 05/18/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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