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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K893592
Device Name LATEX EXAMINATION GLOVES
Applicant
Excel Glove Co., Ltd.
874 Hampswood Way
San Jose,  CA  95120
Applicant Contact SAK ONKVISIT
Correspondent
Excel Glove Co., Ltd.
874 Hampswood Way
San Jose,  CA  95120
Correspondent Contact SAK ONKVISIT
Regulation Number880.6250
Classification Product Code
LYY  
Date Received05/09/1989
Decision Date 08/10/1989
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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