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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 K924633
Device Name HYPOALLERGENIC LATEX GLOVES
Applicant
Pan-Century Rubber Products Sdn. Bhd.
C/O Boston Medical Corp.
12022 Guilford Rd.
Annapolis Junction,  MD  20701
Applicant Contact TIMOTHY F HAND
Correspondent
Pan-Century Rubber Products Sdn. Bhd.
C/O Boston Medical Corp.
12022 Guilford Rd.
Annapolis Junction,  MD  20701
Correspondent Contact TIMOTHY F HAND
Regulation Number880.6250
Classification Product Code
LYY  
Date Received09/08/1992
Decision Date 01/27/1993
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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