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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 K012709
Device Name POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE VERA AND PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (GREEN)
Applicant
Qingdao Bestex Rubber & Plastic Products Co., Ltd.
2576 Lafayette St.
Santa Clara,  CA  95050
Applicant Contact ZECHUAN SHAO
Correspondent
Qingdao Bestex Rubber & Plastic Products Co., Ltd.
2576 Lafayette St.
Santa Clara,  CA  95050
Correspondent Contact ZECHUAN SHAO
Regulation Number880.6250
Classification Product Code
LYY  
Date Received08/14/2001
Decision Date 10/01/2001
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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