Cleared Traditional

Edma Synthetic Nitrile Examination Gloves (K211540) - FDA 510(k) Clearance

Class I General Hospital device.

K211540 · Edma Group, LLC · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2021
Decision
82d
Days
Class 1
Risk

K211540 is an FDA 510(k) clearance for the Edma Synthetic Nitrile Examination Gloves. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Edma Group, LLC (Phoenix, US). The FDA issued a Cleared decision on August 9, 2021 after a review of 82 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 Edma Group, LLC devices

Submission Details

510(k) Number K211540 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 2021
Decision Date August 09, 2021
Days to Decision 82 days
Submission Type Traditional
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
47d faster than avg
Panel avg: 129d · This submission: 82d
Pathway characteristics
Predicate-based equivalence.

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

Shanghai Truthful Information Technology Co., Ltd.
Boyle Wang

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 K211540.
Powder Free Nitrile Patient Examination Gloves, Blue Color
K211860 · Anhui Powerguard Technology Co., Ltd. · Aug 2021
Non-sterile, Powder Free Nitrile Examination Aloe Vera Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, And Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs and Fentanyl Citrate
K202536 · Yty Industry (Manjung) Sdn Bhd · Aug 2021
Nitrile Patient Examination Glove
K210730 · American Performance Polymers, LLC · Aug 2021
Nitrile Patient Examination Glove
K210725 · Pingan Medical Products Co., Ltd. · Aug 2021
Disposable Medical Nitrile Examination Gloves (Non-Sterile)
K211075 · Jiangsu Cherish Medical Technology Co., Ltd. · Aug 2021
Nitrile Patient Examination Gloves
K211434 · Zhangjiagang Huayuan Protective Equipment Co., Ltd. · Aug 2021