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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 K002087
Device Name BESTEX POWDER-FREE LATEX EXAM GLOVES WITH LABELING CLAIM. (50 MICROGRAMS OR LESS)
Applicant
Qingdao Bestex Rubber & Plastic Products Co., Ltd.
205 N. Bayview Ave.
Unit 4
Sunnyvale,  CA  94086
Applicant Contact ZECHUAN SHAO
Correspondent
Qingdao Bestex Rubber & Plastic Products Co., Ltd.
205 N. Bayview Ave.
Unit 4
Sunnyvale,  CA  94086
Correspondent Contact ZECHUAN SHAO
Regulation Number880.6250
Classification Product Code
LYY  
Date Received07/10/2000
Decision Date 09/13/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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