Cleared Traditional

Powder Free Nitrile Examination Glove, Tested for Use with Chemoterapy Drugs (Blue) (K210944) - FDA 510(k) Clearance

Class I General Hospital device.

K210944 · Harbour Health, LLC · General Hospital
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Apr 2021
Decision
30d
Days
Class 1
Risk

K210944 is an FDA 510(k) clearance for the Powder Free Nitrile Examination Glove, Tested for Use with Chemoterapy Drugs .... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Harbour Health, LLC (Newport Beach, US). The FDA issued a Cleared decision on April 29, 2021 after a review of 30 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6250 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Harbour Health, LLC devices

Submission Details

510(k) Number K210944 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2021
Decision Date April 29, 2021
Days to Decision 30 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 129d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

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 Consultant

Third Party Review Group, LLC
Dave Yungvirt

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LZA Polymer Patient Examination Glove

All 489
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K210944.
Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors)
K203036 · Central Medicare Sdn Bhd · May 2021
Blue Nitrile Powder Free Patient Examination Glove, Non Sterile
K210366 · Onetexx Sdn Bhd · May 2021
Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue)
K210755 · Meditech Gloves Sdn Bhd · May 2021
Disposable Nitrile Examination Gloves
K203436 · Shandong Zhushi Pharmaceutical Group Co., Ltd. · Apr 2021
Powder Free Blue Nitrile Examination Glove
K203512 · Vip Glove Sdn Bhd · Apr 2021
Nitrile Glove Powder Free Blue
K210145 · Changzhou Universal Medical Equipment Co., Ltd. · Apr 2021

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.