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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K891861
Device Name PATIENT EXAM GLOVES (MFG. TIANJIN & JINGJIN)
Applicant
China Xinxing Corp. , Ltd.
Shou Song Hotel Wan Shou Rd.
Beijing,  CN
Applicant Contact JINGXIA LI
Correspondent
China Xinxing Corp. , Ltd.
Shou Song Hotel Wan Shou Rd.
Beijing,  CN
Correspondent Contact JINGXIA LI
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/27/1989
Decision Date 07/28/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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