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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vinyl Patient Examination Glove
510(k) Number K893017
Device Name SWED MED STERILE VINYL EXAMINATION GLOVES
Applicant
New England Glove Company
948 Whittier St.
Bronx,  NY  10474
Applicant Contact LAWRENCE STEIN
Correspondent
New England Glove Company
948 Whittier St.
Bronx,  NY  10474
Correspondent Contact LAWRENCE STEIN
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received04/12/1989
Decision Date 09/26/1989
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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