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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 K230832
Device Name Powdered Free Sterile Natural Rubber Latex Surgical Gloves
Applicant
The Egyptian Company For Medical & Electronic Industries
Industrial Zone 7. Part 7062a&B
Sadat City,  EG
Applicant Contact Alaa Elsayed
Correspondent
The Egyptian Company For Medical & Electronic Industries
Industrial Zone 7. Part 7062a&B
Sadat City,  EG
Correspondent Contact Alaa Elsayed
Regulation Number878.4460
Classification Product Code
KGO  
Date Received03/27/2023
Decision Date 08/16/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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