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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgeon'S Gloves
510(k) Number K012104
Device Name SNOW LOTUS POWDER-FREE LATEX SURGEON'S GLOVES
Applicant
Beijing Reagent Latex Products Co., Ltd.
# 30 S. Sanlitun Rd.,
Dongdaqiao
Chaowai, Beijing, P.R.,  CN 100020
Applicant Contact WANG YANNAN
Correspondent
Beijing Reagent Latex Products Co., Ltd.
# 30 S. Sanlitun Rd.,
Dongdaqiao
Chaowai, Beijing, P.R.,  CN 100020
Correspondent Contact WANG YANNAN
Regulation Number878.4460
Classification Product Code
KGO  
Date Received07/05/2001
Decision Date 08/21/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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