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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 K946291
Device Name ELASTYREN(R) PATIENT EXAMINATION GLOVES
Applicant
Eci Medical Technologies, Inc.
44 E. Beaver Creek Rd.
Bldg. 5
Richmondhill, Ontario,  CA L4B 1G8
Applicant Contact DONALD HOLSTEN
Correspondent
Eci Medical Technologies, Inc.
44 E. Beaver Creek Rd.
Bldg. 5
Richmondhill, Ontario,  CA L4B 1G8
Correspondent Contact DONALD HOLSTEN
Regulation Number880.6250
Classification Product Code
LZA  
Date Received12/27/1994
Decision Date 02/14/1995
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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