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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vinyl Patient Examination Glove
510(k) Number K993847
Device Name TEH LOONG, VINYL, POWDERED, PATIENT EXAMINATION GLOVES
Applicant
Longbest (Xiamen) Balls Co., Ltd.
# 18 Chin Liu St.
Shiaukang Dist.
Kaohsiung,  TW
Applicant Contact T.H. CHEN
Correspondent
Longbest (Xiamen) Balls Co., Ltd.
# 18 Chin Liu St.
Shiaukang Dist.
Kaohsiung,  TW
Correspondent Contact T.H. CHEN
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received11/12/1999
Decision Date 01/18/2000
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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