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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 K891825
Device Name PATIENT EXAMINATION GLOVES (LATEX)
Applicant
J & T Medical Products Co., Ltd.
3318 Woodburn Village Dr.
Suite 11
Annandale,  VA  22003
Applicant Contact JOSEPH A LYKINS
Correspondent
J & T Medical Products Co., Ltd.
3318 Woodburn Village Dr.
Suite 11
Annandale,  VA  22003
Correspondent Contact JOSEPH A LYKINS
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/24/1989
Decision Date 06/06/1989
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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