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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 K040408
Device Name POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING (LESS THAN 50 UG/G PER GLOVE)
Applicant
Shun Thai Rubber Gloves Industry Public Co., Ltd.
198 Ave. De La D'Emerald
Sparks,  NV  89434
Applicant Contact JANNA P TUCKER
Correspondent
Shun Thai Rubber Gloves Industry Public Co., Ltd.
198 Ave. De La D'Emerald
Sparks,  NV  89434
Correspondent Contact JANNA P TUCKER
Regulation Number880.6250
Classification Product Code
LYY  
Date Received02/17/2004
Decision Date 03/17/2004
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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