510(k) K882533

LATEX EXAMINATION GLOVE by Sukas Export — Product Code FMC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 1988
Date Received
June 21, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Patient Examination Glove
Device Class
Class I
Regulation Number
880.6250
Review Panel
HO
Submission Type