Cleared Abbreviated

Blue Nitrile Examination Gloves Powder Free (K230601) - FDA 510(k) Clearance

Class I General Hospital device.

K230601 · Latrile Gloves Private Limited · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2023
Decision
86d
Days
Class 1
Risk

K230601 is an FDA 510(k) clearance for the Blue Nitrile Examination Gloves Powder Free. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Latrile Gloves Private Limited (Dindigul, IN). The FDA issued a Cleared decision on May 28, 2023 after a review of 86 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 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 Latrile Gloves Private Limited devices

Submission Details

510(k) Number K230601 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2023
Decision Date May 28, 2023
Days to Decision 86 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
43d faster than avg
Panel avg: 129d · This submission: 86d
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 Consultant

Liberty Management Group , Ltd.
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 489
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K230601.
APOLLO ADVANTAGE Nitrile Examination Gloves
K230633 · Dell Corning Corporation · Jun 2023
Disposable Nitrile Gloves (ABC-DG01)
K230542 · Huizhou Anboson Technology Co., Ltd. · May 2023
First Glove Blue Nitrile Examination Gloves Powder Free
K230958 · First Glove Sdn. Bhd. · May 2023
Green Non Sterile Powder Free Nitrile Examination Gloves
K230564 · Central Medicare Sdn Bhd · May 2023
Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour)
K223437 · Hartalega NGC Sdn. Bhd. · May 2023
Nitrile Examination Gloves Powder Free Tested For Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black)
K230121 · Careglove Global Sdn. Bhd. · May 2023