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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 K912038
Device Name DASH MEDICAL GLOVES
Applicant
Safehealth Labs
C/O Regulatory/Technical Assoc
73 Franklin Tpk.
Allendale,  NJ  07401
Applicant Contact ROBERT J STAABB
Correspondent
Safehealth Labs
C/O Regulatory/Technical Assoc
73 Franklin Tpk.
Allendale,  NJ  07401
Correspondent Contact ROBERT J STAABB
Regulation Number880.6250
Classification Product Code
LYY  
Date Received05/08/1991
Decision Date 06/03/1991
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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