Cleared Abbreviated

K240930 - Non-sterile

Also marketed or referenced as:
Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with 55 Chemotherapy Drugs and Fentanyl- Blue

K240930 is an FDA 510(k) clearance for Non-sterile, manufactured by Sri Trang Gloves (Thailand) Public Company Limited. The device is a Class 1 General Hospital device with product code LZA cleared through the Abbreviated 510(k) pathway after a 89-day FDA review.

K240930 · Sri Trang Gloves (Thailand) Public Company Limited · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2024
Decision
89d
Days
Class 1
Risk

K240930 is an FDA 510(k) clearance for the Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with 55 Che.... 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 July 2, 2024 after a review of 89 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 Sri Trang Gloves (Thailand) Public Company Limited devices

FDA 510(k) Submission Details - K240930

510(k) Number K240930 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2024
Decision Date July 02, 2024
Days to Decision 89 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
40d faster than avg
Panel avg: 129d · This submission: 89d
Pathway characteristics
Standards-based clearance path.

LZA Device Classification - Class 1, General Controls

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 Peers - LZA Polymer Patient Examination Glove

All 682
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K240930.
Cardinal Health Nitrile Exam Gloves
K241780 · Cardinal Health200, LLC · Aug 2024
Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential
K241528 · Comfort Rubber Gloves Industries Sdn. Bhd. · Aug 2024
Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS,S,M,L,XL,XXL)
K241970 · Kanglongda Vietnam Protection Technology Company Limited · Aug 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
Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl (White, Black, and Violet Blue)
K232614 · Sri Trang Gloves (Thailand) Public Company Limited · May 2024