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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Patient Examination Glove
510(k) Number K905109
Device Name PATIENT EXAMINATION GLOVE/HYPOALLERGENIC
Applicant
Tactyl Technologies, Inc.
2595 Commerce Way
Vista,  CA  92083
Applicant Contact BUDDENHAGEN
Correspondent
Tactyl Technologies, Inc.
2595 Commerce Way
Vista,  CA  92083
Correspondent Contact BUDDENHAGEN
Regulation Number880.6250
Classification Product Code
FMC  
Date Received11/13/1990
Decision Date 11/21/1990
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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