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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 K892968
Device Name TUFFTEX PATIENT EXAM GLOVES
Applicant
Thai Latex, Inc.
222 Kingfisher Way
Royal Palm Beach,  FL  33411
Applicant Contact DAVID SALISBURY
Correspondent
Thai Latex, Inc.
222 Kingfisher Way
Royal Palm Beach,  FL  33411
Correspondent Contact DAVID SALISBURY
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/12/1989
Decision Date 09/18/1989
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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