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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vinyl Patient Examination Glove
510(k) Number K892766
Device Name PATIENT EXAMINATION GLOVES (VINYL)
Applicant
Gigantic International Corp.
11727 E. Washington Blvd.
Whittier,  CA  90606
Applicant Contact JULIE LEE
Correspondent
Gigantic International Corp.
11727 E. Washington Blvd.
Whittier,  CA  90606
Correspondent Contact JULIE LEE
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received04/11/1989
Decision Date 07/14/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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