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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 K894192
Device Name PATIENT EXAMINATION GLOVES
Applicant
Royal Pacific Intl. Trade, Inc.
C/O Graham & James-Attorneys
2000 M St., NW, Suite 700
Washington,  DC  20036
Applicant Contact DANIEL J MANELLI
Correspondent
Royal Pacific Intl. Trade, Inc.
C/O Graham & James-Attorneys
2000 M St., NW, Suite 700
Washington,  DC  20036
Correspondent Contact DANIEL J MANELLI
Regulation Number880.6250
Classification Product Code
LYY  
Date Received06/12/1989
Decision Date 08/01/1989
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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