Cleared Abbreviated

Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl (White, Black, and Violet Blue) (K232614) - FDA 510(k) Clearance

Class I General Hospital device.

K232614 · Sri Trang Gloves (Thailand) Public Company Limited · General Hospital
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Optimized for regulatory review, auditing and printing
May 2024
Decision
259d
Days
Class 1
Risk

K232614 is an FDA 510(k) clearance for the Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemot.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Sri Trang Gloves (Thailand) Public Company Limited (Hatyai, TH). The FDA issued a Cleared decision on May 13, 2024 after a review of 259 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 Sri Trang Gloves (Thailand) Public Company Limited devices

Submission Details

510(k) Number K232614 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2023
Decision Date May 13, 2024
Days to Decision 259 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
130d slower than avg
Panel avg: 129d · This submission: 259d
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

Sri Trang USA, Inc.
M. Jordan Smith

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 K232614.
Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with 55 Chemotherapy Drugs and Fentanyl- Violet Blue
K240930 · Sri Trang Gloves (Thailand) Public Company Limited · Jul 2024
Disposable Medical Nitrile Examination Gloves (Non sterile) (QN-N001, QN-N002, QN-N003, QN-N004, QN-N005)
K240824 · Ningxia Qiaoen Medical Technology Co., Ltd. · Jun 2024
Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl
K240629 · Xingyu Medical Tech Co., Ltd. · May 2024
Black Pearl Nitrile Examination Glove
K232319 · Ug Global Resources Sdn. Bhd. · Apr 2024
Powder Free Nitrile Examination Glove 3.5, Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
K240021 · Yue Kang Anhui Medical Products Co., Ltd. · Apr 2024
Powder Free Green Nitrile Examination Gloves (XS/S/M/L/XL)
K240361 · Hebei Titans Hongsen Medical Technology Co., Ltd. · Apr 2024