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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 K952695
Device Name BOSTON MEDICAL LATEX EXAM GLOVES
Applicant
Shun Thai Rubber Gloves Industry Co., Ltd.
198 Ave. De La D'Emerald
Sparks,  NV  89434
Applicant Contact WILLIAM C LOWENKAMP
Correspondent
Shun Thai Rubber Gloves Industry Co., Ltd.
198 Ave. De La D'Emerald
Sparks,  NV  89434
Correspondent Contact WILLIAM C LOWENKAMP
Regulation Number880.6250
Classification Product Code
LYY  
Date Received06/14/1995
Decision Date 08/11/1995
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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