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510(k) K141021

POWDER-FREE NITRILE EXAMINATION GLOVES, ORANGE, COLOR by Hl Rubber Industries Sdn Bhd — Product Code LZA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 2014
Date Received
April 21, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

A nitrile (or polymer) patient examination glove is a disposable device made of nitrile rubber or synthetic polymers 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 Hl Rubber Industries Sdn Bhd

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  • K130038 — POWDER-FREE NITRILE EXAMINATION GLOVES, BLUE (February 21, 2013)
  • K100369 — POWDER-FREE NITRILE GLOVES, BLACK (May 20, 2010)
  • K063522 — POWDER NITRILE EXAMINATION GLOVE (WHITE AND BLUE COLOR) (February 8, 2007)
  • K063524 — POWDER FREE NITRILE EXAMINATION GLOVES (WHITE AND BLUE COLOR) (January 23, 2007)

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