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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K901394
Device Name ELASTYREN - EXAMINATION AND DENTAL GLOVES
Applicant
Danpren Gloves A/S
15 Roholmsvej
Dk 2620 Albertslund
Denmark,  DK
Applicant Contact BENT NIELSEN
Correspondent
Danpren Gloves A/S
15 Roholmsvej
Dk 2620 Albertslund
Denmark,  DK
Correspondent Contact BENT NIELSEN
Regulation Number880.6250
Classification Product Code
LZA  
Date Received03/26/1990
Decision Date 08/10/1990
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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