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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 K993849
Device Name TEH LOONG VINYL, POWDER-FREE, PATIENT EXAMINATION GLOVE
Applicant
LONGBEST (XIAMEN) BALLS CO., LTD
NO. 18 CHIN LIU ST
SHIAUKANG DIST.
KAOHSIUNG,  TW
Applicant Contact STONE CHEN
Correspondent
LONGBEST (XIAMEN) BALLS CO., LTD
NO. 18 CHIN LIU ST
SHIAUKANG DIST.
KAOHSIUNG,  TW
Correspondent Contact STONE 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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