Cleared Traditional

Blue Nitrile Powder Free Patient Examination Glove, Non Sterile (K210366) - FDA 510(k) Clearance

Class I General Hospital device.

K210366 · Onetexx Sdn Bhd · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2021
Decision
88d
Days
Class 1
Risk

K210366 is an FDA 510(k) clearance for the Blue Nitrile Powder Free Patient Examination Glove, Non Sterile. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Onetexx Sdn Bhd (Kamunting, MY). The FDA issued a Cleared decision on May 7, 2021 after a review of 88 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 Onetexx Sdn Bhd devices

Submission Details

510(k) Number K210366 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2021
Decision Date May 07, 2021
Days to Decision 88 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
41d faster than avg
Panel avg: 129d · This submission: 88d
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

Emergo Global Representation
Michael Van Der Woude

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 K210366.
Nitrile Patient Examination Gloves
K211028 · Huayuan Medical Technology(Shangqiu) Co., Ltd. · Jun 2021
Powder Free Nitrile Examination Glove
K210369 · Pastel Glove Sdn Bhd · May 2021
Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors)
K203036 · Central Medicare Sdn Bhd · May 2021
Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue)
K210755 · Meditech Gloves Sdn Bhd · May 2021
Powder Free Nitrile Examination Glove, Tested for Use with Chemoterapy Drugs (Blue)
K210944 · Harbour Health, LLC · Apr 2021
Disposable Nitrile Examination Gloves
K203436 · Shandong Zhushi Pharmaceutical Group Co., Ltd. · Apr 2021