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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 K892461
Device Name NON-STERILE LATEX EXAMINATION GLOVES
Applicant
Rahn Laboratories
P.O. Box 126
Bland,  VA  24315
Applicant Contact RANDAL J KIRK
Correspondent
Rahn Laboratories
P.O. Box 126
Bland,  VA  24315
Correspondent Contact RANDAL J KIRK
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/07/1989
Decision Date 07/28/1989
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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