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510(k) K914691

INDIVIDUAL/LARGE/BELT FIRST AID KITS by The Lighthouse For the Blind, Inc. — Product Code LYY

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
January 15, 1992
Date Received
October 18, 1991
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 The Lighthouse For the Blind, Inc.

  • K941869 — SPLINT, PNEUMATIC, ARM & SPLINT, PNEUMATIC, LEG (August 3, 1994)

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  • K222612 — Powder-Free Latex examination gloves (November 25, 2022)
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  • K222348 — JR MEDIC (October 27, 2022)
  • K221374 — Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL) (October 26, 2022)
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  • K221648 — Iconic Latex Glove (August 25, 2022)