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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 K890858
Device Name PATIENT EXAMINATION GLOVES
Applicant
Rejuvena Ent. Co. , Ltd.
3-3 Floor , 258 Hoping E. Rd.
Sec 3, Taipei 10679
Taiwan R.O.C.,  TW
Applicant Contact WEN LIU
Correspondent
Rejuvena Ent. Co. , Ltd.
3-3 Floor , 258 Hoping E. Rd.
Sec 3, Taipei 10679
Taiwan R.O.C.,  TW
Correspondent Contact WEN LIU
Regulation Number880.6250
Classification Product Code
LYY  
Date Received02/21/1989
Decision Date 07/14/1989
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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