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510(k) K180646

Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs by Halyard Health — Product Code LZC

K180646 is an FDA 510(k) premarket notification submitted by Halyard Health for the device "Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs". The FDA issued a decision of Substantially Equivalent on June 27, 2018. The device falls under product code LZC (Medical Glove, Specialty), a Class I device regulated under 21 CFR 880.6250. Halyard Health has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 2018
Date Received
March 12, 2018
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

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.

Other clearances by Halyard Health

  • K181360 — ON-Q* Pump with Bolus (March 22, 2019)
  • K173955 — Mic-Key* SF Over-the-Wire Stoma Measuring Device (January 26, 2018)
  • K162930 — Aero Chrome* Select Breathable Performance Surgical Gowns (April 21, 2017)
  • K163461 — Coolief* Cooled RF Probe (April 13, 2017)
  • K163236 — COOLIEF Cooled Radiofrequency Kit (December 16, 2016)
  • K161232 — ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Blo (September 30, 2016)
  • K160709 — HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves (September 6, 2016)
  • K153255 — Aero Chrome* Breathable Performance Surgical Gown (April 13, 2016)
  • K153708 — Halyard Black-Orange Powder-Free Nitrile Exam Glove (March 31, 2016)
  • K150113 — Fusion Black Powder-Free Nitrile Exam Glove (June 18, 2015)

Other clearances for product code LZC

  • K252313 — Cardinal Health Nitrile Examination Gloves Extended Cuff (January 14, 2026)
  • K243959 — Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use wi (February 24, 2025)
  • 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)

FDA data resources