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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 K893047
Device Name JASONTEX LATEX EXAMINATION GLOVES
Applicant
Jasontex Co., Ltd.
1016 Seward Ave.
Westfield,  NJ  07090
Applicant Contact S CHANG
Correspondent
Jasontex Co., Ltd.
1016 Seward Ave.
Westfield,  NJ  07090
Correspondent Contact S CHANG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/13/1989
Decision Date 06/14/1989
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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