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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 K031157
Device Name POWDER-FREE NITRILE EXAMINATION GLOVE (BLUE) WITH NATURAL WATER SOLUBLE VITAMIN E AND ALOE VERA, PEPPERMINT SCENTED
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
LZA  
Date Received04/11/2003
Decision Date 08/15/2003
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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