Cleared Abbreviated

USA Gloves Nitrile Powder Free Exam Gloves (K211624) - FDA 510(k) Clearance

Class I General Hospital device.

K211624 · Usa Gloves · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2021
Decision
205d
Days
Class 1
Risk

K211624 is an FDA 510(k) clearance for the USA Gloves Nitrile Powder Free Exam Gloves. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Usa Gloves (Sugar Land, US). The FDA issued a Cleared decision on December 18, 2021 after a review of 205 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 Usa Gloves devices

Submission Details

510(k) Number K211624 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 2021
Decision Date December 18, 2021
Days to Decision 205 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
76d slower than avg
Panel avg: 129d · This submission: 205d
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 489
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K211624.
Glovmaster Nitrile Examination Glove Powder Free
K212914 · Glovmaster Sdn. Bhd. · Dec 2021
Powder Free Nitrile Examination Gloves, Non-sterile,Tested For Use with Chemotherapy Drugs and Opioid Fentanyl Citrate (Blue)
K212613 · Koon Seng Sdn Bhd · Dec 2021
Powder Free Nitrile Examination Gloves (Blue, Black, Indigo)
K211457 · Ammex Corporation · Dec 2021
Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs)
K213048 · Huayuan Medical Technology(Shangqiu) Co., Ltd. · Dec 2021
Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs)
K213051 · Yunnan Huazhiyuan Medical Technology Co., Ltd. · Dec 2021
Hycare Med+ Nitrile Examination Gloves
K211209 · Hycare International Co., Ltd. · Dec 2021