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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 K892300
Device Name PATIENT EXAMINATION GLOVES (LATEX)
Applicant
Ryoden Intl., Ltd.
14/F, Leighton Centre
77 Leighton Rd., Causeway Bay
Hong Kong,  HK
Applicant Contact KAM SHING
Correspondent
Ryoden Intl., Ltd.
14/F, Leighton Centre
77 Leighton Rd., Causeway Bay
Hong Kong,  HK
Correspondent Contact KAM SHING
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/06/1989
Decision Date 01/24/1990
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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