Cleared Abbreviated

Halyard STERLING* Nitrile Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid; Halyard STERLING SG* SENSI-GUARD Powder-Free Nitrile Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid; Halyard STERLING NITRILE-XTRA * Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid

K231938 · O&M Halyard, Inc. · General Hospital

Mar 2024

Decision

266d

Days

Class 1

Risk

About This 510(k) Submission

K231938 is an FDA 510(k) clearance for the Halyard STERLING* Nitrile Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid; Halyard STERLING SG* SENSI-GUARD Powder-Free Nitrile Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid; Halyard STERLING NITRILE-XTRA * Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid, 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 March 22, 2024, 266 days after receiving the submission on June 30, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number	K231938 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 30, 2023
Decision Date	March 22, 2024
Days to Decision	266 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.