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510(k) K101596

KIMBERLY-CLARK PURPLE NITRILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) AND KIMBERLY-CLARK PURPLE NITRILE XTRA POWDER- by Kimberly-Clark — Product Code LZC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 2010
Date Received
June 8, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Medical Glove, Specialty
Device Class
Class I
Regulation Number
880.6250
Review Panel
HO
Submission Type

A disposable medical glove (examination or surgeon’s) is a device that may or may not bear a trace amount of residual powder and is intended to be worn on the hand or finger(s) for medical purposes to prevent contamination. In addition, these gloves may have specialty claims such as chemotherapy, etc.

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  • K131879 — KC 300 SURGICAL MASK (December 20, 2013)
  • K131841 — KIMBERLY-CLARK LAVENDER NITRILE POWDER-FREE EXAM GLOVE (November 7, 2013)
  • K131254 — KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE (August 20, 2013)
  • K120985 — KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING (December 19, 2012)
  • K112805 — KIMGUARD ONE-STEP STERILIZATION WRAP (June 22, 2012)
  • K113340 — KIMBERLY-CLARK CHILD'S FACEMASK (May 4, 2012)
  • K113423 — KIMBERLY CLARK PURPLE NITRILE, AND PURPLE NITRILE XTRA POWDER FREE EXAM GLOVE (March 9, 2012)
  • K112300 — KIMGUARD SMART-FOLD* STERILIZATION WRAP (January 19, 2012)

Other clearances for product code LZC

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  • K221157 — JR Medic (August 30, 2022)
  • K222449 — Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs A (August 27, 2022)
  • K220545 — Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy D (May 26, 2022)
  • K220491 — Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy (May 14, 2022)
  • K220353 — Disposal Medical Nitrile Examination Gloves-Tested for Use with Chemotherapy Dru (March 31, 2022)
  • K213910 — Disposable Medical Nitrile Examination Gloves- Tested for Use with Chemotherapy (March 10, 2022)
  • K213325 — Disposable Medical Nitrile Examination Gloves- Tested for Use With Chemotherapy (January 28, 2022)
  • K213076 — AspenMed+ (December 20, 2021)