Cleared Traditional

Nitrile Examination Gloves (K222813) - FDA 510(k) Clearance

Class I General Hospital device.

K222813 · Ecoglove Medical Manufacturing Company Limited · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2023
Decision
178d
Days
Class 1
Risk

K222813 is an FDA 510(k) clearance for the Nitrile Examination Gloves. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Ecoglove Medical Manufacturing Company Limited (Lai Uyen Town, Bau Bang District, VN). The FDA issued a Cleared decision on March 16, 2023 after a review of 178 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Ecoglove Medical Manufacturing Company Limited devices

Submission Details

510(k) Number K222813 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2022
Decision Date March 16, 2023
Days to Decision 178 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
49d slower than avg
Panel avg: 129d · This submission: 178d
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

Liberty Management Group Limited
Manoj Zacharias

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 K222813.
Non-sterile, Powder Free, ambidextrous, textured, beaded cuff, single use, Doffy® Nitrile Examination Glove, Tested for use with Chemotherapy Drugs
K220644 · Yty Industry (Manjung) Sdn Bhd · Mar 2023
Nitrile Powder Free Black Patient Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs
K230002 · Mah Sing Healthcare Sdn. Bhd. · Mar 2023
Disposable Medical Nitrile Examination Gloves
K223895 · Hebei Titans Hongsen Medical Technology Co., Ltd. · Mar 2023
Tegamen Nitrile Examination Gloves
K223102 · M/S Tegamen Safety Products Private Limited · Mar 2023
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate.
K223375 · Kossan International Sdn Bhd3 · Mar 2023
Rhino Non-sterile Powder-Free Nitrile Exam Glove – Periwinkle Color Tested for Use with Chemotherapy Drugs and Fentanyl
K223859 · Rhino Health, Inc. · Feb 2023