Cleared Abbreviated

Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution

K213937 · O&M Halyard, Inc. · General Hospital
Aug 2022
Decision
243d
Days
Class 1
Risk

About This 510(k) Submission

K213937 is an FDA 510(k) clearance for the Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution, a Polymer Patient Examination Glove (Class I — General Controls, product code LZA), submitted by O&M Halyard, Inc. (Alpharetta, US). The FDA issued a Cleared decision on August 16, 2022, 243 days after receiving the submission on December 16, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number K213937 FDA.gov
FDA Decision Cleared SESE
Date Received December 16, 2021
Decision Date August 16, 2022
Days to Decision 243 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code LZA — Polymer Patient Examination Glove
Device Class Class I — General Controls
CFR Regulation 21 CFR 880.6250
Definition 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.

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