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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K992686
Device Name DISPOSABLE POWDER FREE NITRILE EXAM GLOVE, BLUE COLOR
Applicant
Sheen More Ent. Co., Ltd.
#16, Tou Kung Six Rd.
Tou-Liu Expanded Indust. Park
Tou-Liu, Yun-Lin,  TW
Applicant Contact KEN HUANG
Correspondent
Sheen More Ent. Co., Ltd.
#16, Tou Kung Six Rd.
Tou-Liu Expanded Indust. Park
Tou-Liu, Yun-Lin,  TW
Correspondent Contact KEN HUANG
Regulation Number880.6250
Classification Product Code
LZA  
Date Received08/10/1999
Decision Date 09/24/1999
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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