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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 K891509
Device Name PATIENT EXAMINATION GLOVES (LATEX)
Applicant
Delaware Industries, Inc.
175 Great Neck Rd.
Great Neck,  NY  11021
Applicant Contact IDA NOVICK
Correspondent
Delaware Industries, Inc.
175 Great Neck Rd.
Great Neck,  NY  11021
Correspondent Contact IDA NOVICK
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/16/1989
Decision Date 09/11/1989
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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