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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 K110972
Device Name POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR
Applicant
Ppp Medical and Safety Products Company Limited
Rm. 1606 Bldg. 1 Jian Xian
Yuan #209 Bei Si Huan Zhong
Rd. Hai Di Beijing,  CN 100083
Applicant Contact CHU XIAOAN
Correspondent
Ppp Medical and Safety Products Company Limited
Rm. 1606 Bldg. 1 Jian Xian
Yuan #209 Bei Si Huan Zhong
Rd. Hai Di Beijing,  CN 100083
Correspondent Contact CHU XIAOAN
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received04/06/2011
Decision Date 06/06/2011
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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