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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 K902282
Device Name ULTRA.SPEC NON-STERILE LATEX EXAMINATION GLOVE
Applicant
Ncl Corp.
2830 Gilchrist Rd.
Akron,  OH  44305
Applicant Contact BUSTER, SR.
Correspondent
Ncl Corp.
2830 Gilchrist Rd.
Akron,  OH  44305
Correspondent Contact BUSTER, SR.
Regulation Number880.6250
Classification Product Code
LYY  
Date Received05/22/1990
Decision Date 06/07/1990
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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