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510(k) K891795

DISPOSABLE LATEX EXAM GLOVES by Eagle Medical, Inc. — Product Code LYY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 1989
Date Received
March 23, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

A latex patient examination glove is a disposable device made of natural rubber latex that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.

Other clearances by Eagle Medical, Inc.

  • K933661 — INSUFFLATOR TUBING KIT W/FILTER (August 25, 1993)
  • K915591 — STERILE GAUZE PADS (January 27, 1993)

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