Cleared Traditional

Nitrile Exam Gloves (Chemotherapy Drug Tested) (K223748) - FDA 510(k) Clearance

Class I General Hospital device.

K223748 · Us Medical Glove Company, LLC · General Hospital
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Jan 2023
Decision
30d
Days
Class 1
Risk

K223748 is an FDA 510(k) clearance for the Nitrile Exam Gloves (Chemotherapy Drug Tested). Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Us Medical Glove Company, LLC (Montgomery, US). The FDA issued a Cleared decision on January 13, 2023 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 Us Medical Glove Company, LLC devices

Submission Details

510(k) Number K223748 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 2022
Decision Date January 13, 2023
Days to Decision 30 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
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

Regulatory Technology Services, LLC
Prithul Bom

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 496
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K223748.
Synthetic Polymer Glove - Polyethylene (Black)
K222531 · Ur Industry Sdn Bhd · Jan 2023
Disposable Nitrile Examination Glove
K223250 · Yangzhou Saraguard Medical Supplies Co., Ltd. · Jan 2023
Non-Sterile Powder Free Nitrile Examination Gloves
K223221 · Dynacare Sdn Bhd · Jan 2023
Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl Citrate
K222181 · Iconic Medicare Sdn Bhd · Jan 2023
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
K222907 · Rmkh Glove (Cambodia) Co., Ltd. · Jan 2023
Powder Free Polyurethane Examination Gloves, Blue color, Tested for use with Chemotherapy Drugs
K222892 · Grand Work Plastic Products Co., Ltd. · Dec 2022

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.