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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 K102838
Device Name PATIENT EXAMINATION GLOVES
Applicant
Thai Hua Holding Co., Ltd.
6324 Meetinghouse Way
Alexandria,  VA  22312
Applicant Contact KOK-KEE HON
Correspondent
Thai Hua Holding Co., Ltd.
6324 Meetinghouse Way
Alexandria,  VA  22312
Correspondent Contact KOK-KEE HON
Regulation Number880.6250
Classification Product Code
LYY  
Date Received09/29/2010
Decision Date 02/03/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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