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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 K893267
Device Name PATIENT EXAMINATION GLOVES
Applicant
Hubei Provincial Medicines & Health Products Impor
196 Jingwu Rd.
Hankou, China,  CN 430022
Applicant Contact FANG YOU-HONG
Correspondent
Hubei Provincial Medicines & Health Products Impor
196 Jingwu Rd.
Hankou, China,  CN 430022
Correspondent Contact FANG YOU-HONG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/17/1989
Decision Date 08/09/1989
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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