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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 K982416
Device Name SHUN-THAI - SAFE-CONTACT, BOSTON MEDICAL LATEX EXAM GLOVE, SHUN-THAI LATEX EXMINATION GLOVE
Applicant
Shun Thai Rubber Gloves Industry Co., Ltd.
1034-1054 Lowenkamp Ln.
P.O. Box 878
Hazelhurst,  MS  39083
Applicant Contact WILLIAM C LOWENKAMP
Correspondent
Shun Thai Rubber Gloves Industry Co., Ltd.
1034-1054 Lowenkamp Ln.
P.O. Box 878
Hazelhurst,  MS  39083
Correspondent Contact WILLIAM C LOWENKAMP
Regulation Number880.6250
Classification Product Code
LYY  
Date Received07/13/1998
Decision Date 11/24/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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