Cleared Abbreviated

Halyard Lavender, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and and Fentanyl Citrate (K202622) - FDA 510(k) Clearance

Class I General Hospital device.

K202622 · O&M Halyard, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2021
Decision
119d
Days
Class 1
Risk

K202622 is an FDA 510(k) clearance for the Halyard Lavender, Low Dermatitis Potential, Powder-Free Exam Gloves Tested fo.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by O&M Halyard, Inc. (Alpharetta, US). The FDA issued a Cleared decision on January 7, 2021 after a review of 119 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6250 - the FDA general hospital device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all O&M Halyard, Inc. devices

Submission Details

510(k) Number K202622 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 2020
Decision Date January 07, 2021
Days to Decision 119 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 129d · This submission: 119d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code LZA Polymer Patient Examination Glove
Device Class Class 1 - 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.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LZA Polymer Patient Examination Glove

All 496
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K202622.
Nitrile Examination Gloves (Blue, Violet Blue, White)
K202402 · Jiangsu Tianshuo Medical Products Co., Ltd. · Mar 2021
Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim
K202003 · Gmp Medicare Sdn. Bhd. · Feb 2021
LYDUS Nitrile Examination Gloves, Powder Free
K203191 · Nathan Trading Co., Ltd. · Feb 2021
Palm Care Blue Nitrile Examination Gloves Powder Free
K202384 · Hi-Care Thai Gloves Co. , Ltd. · Dec 2020
Kimtech Prizm Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid, Kimtech Prizm Xtra Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid
K202416 · Kimberly Clark Corporation · Nov 2020
Medline Powder-Free Orange Nitrile Patient Examination Glove (Tested for use with Fentanyl)
K200150 · Medline Industries, Inc. · Oct 2020