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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 K892685
Device Name PATIENT EXAMINATION GLOVES DUBBLE BUTTERFLY
Applicant
China National Chemical Construction Corp.-Qingdao
# 49 Shao Guan Rd.
Quingdao China,  CN
Applicant Contact SUN JIE
Correspondent
China National Chemical Construction Corp.-Qingdao
# 49 Shao Guan Rd.
Quingdao China,  CN
Correspondent Contact SUN JIE
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/11/1989
Decision Date 08/10/1989
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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