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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 K052729
Device Name POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED)
Applicant
Shijiazhuang Brilliant Ocean Plastic Co., Ltd.
Rm.1606 Bldg. 1 Jiangxiang Yuan
Bei Si Huan Zhong Rd.
Beijing,  CN 100083
Applicant Contact CHU XIAOAN
Correspondent
Shijiazhuang Brilliant Ocean Plastic Co., Ltd.
Rm.1606 Bldg. 1 Jiangxiang Yuan
Bei Si Huan Zhong Rd.
Beijing,  CN 100083
Correspondent Contact CHU XIAOAN
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received09/29/2005
Decision Date 01/19/2006
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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