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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 K905585
Device Name PATIENT EXAM GLOVES(MFG: LIAONING MACHINERY)
Applicant
Pioneer Trading Co.
2435 Kimberly Rd., #220n
Bettendorf,  IA  52722
Applicant Contact RICHARD MOORE
Correspondent
Pioneer Trading Co.
2435 Kimberly Rd., #220n
Bettendorf,  IA  52722
Correspondent Contact RICHARD MOORE
Regulation Number880.6250
Classification Product Code
LYY  
Date Received12/13/1990
Decision Date 12/21/1990
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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