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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 K891136
Device Name PATIENT EXAMINATION GLOVE (LATEX)
Applicant
Advance Rubber, Inc.
P.O. Box 24-637
Suite 5-1, Jen. Ai, Rd., Sec 3
Taipei, Taiwan R.O.C.,  TW
Applicant Contact PHILIP SHEN
Correspondent
Advance Rubber, Inc.
P.O. Box 24-637
Suite 5-1, Jen. Ai, Rd., Sec 3
Taipei, Taiwan R.O.C.,  TW
Correspondent Contact PHILIP SHEN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/03/1989
Decision Date 08/22/1989
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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