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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 K042028
Device Name VINYL EXAMINATION GLOVE, POWDER-FREE, NON-STERILE
Applicant
Zibo Borui Plastic & Rubber Products Co., Ltd.
10 Seton Ct.
Rancho Mirage,  CA  92270
Applicant Contact MARY ANN DOUCETTE
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received07/28/2004
Decision Date 08/09/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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