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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 K893726
Device Name LATEX GLOVE, EXAMINATION
Applicant
Lixin Hygienical Products Factory Co., Ltd.
Geuihua Rd., N. Gonbei
Zhuhai, Guangdong Province Of
China,  CN
Applicant Contact R U.S.
Correspondent
Lixin Hygienical Products Factory Co., Ltd.
Geuihua Rd., N. Gonbei
Zhuhai, Guangdong Province Of
China,  CN
Correspondent Contact R U.S.
Regulation Number880.6250
Classification Product Code
LYY  
Date Received05/17/1989
Decision Date 09/29/1989
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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