Cleared Abbreviated

K211063 - HALYARD Flexaprene Green Powder-Free Ex...

K211063 is the FDA 510(k) clearance for HALYARD Flexaprene Green Powder-Free Ex... by O&M Halyard, Inc.. It is a Class 1 General Hospital device (product code LZA) cleared through the Abbreviated 510(k) pathway after a 224-day FDA review.

K211063 · O&M Halyard, Inc. · General Hospital
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Nov 2021
Decision
224d
Days
Class 1
Risk

K211063 is an FDA 510(k) clearance for the HALYARD Flexaprene Green Powder-Free Exam Glove. 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 November 19, 2021 after a review of 224 days - an extended review cycle.

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 K211063 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 2021
Decision Date November 19, 2021
Days to Decision 224 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d slower than avg
Panel avg: 129d · This submission: 224d
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 612
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K211063.
Powder free nitrile examination glove- blue, non-sterile
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K212661 · Inner Mongolia Cureguard Medical Technology Co., Ltd. · Nov 2021
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K212600 · Suqian Linglian Medical Technology Co., Ltd. · Nov 2021
Disposable Medical Nitrile Examination Gloves (non-sterile)
K212029 · Taizhou Kangjian Medical Equipments Co., Ltd. · Nov 2021