Cleared Special

Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS,S,M,L,XL,XXL) (K241970) - FDA 510(k) Clearance

Class I General Hospital device.

K241970 · Kanglongda Vietnam Protection Technology Company Limited · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2024
Decision
28d
Days
Class 1
Risk

K241970 is an FDA 510(k) clearance for the Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemothera.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Kanglongda Vietnam Protection Technology Company Limited (Thua Thien Hue, VN). The FDA issued a Cleared decision on August 2, 2024 after a review of 28 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Kanglongda Vietnam Protection Technology Company Limited devices

Submission Details

510(k) Number K241970 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2024
Decision Date August 02, 2024
Days to Decision 28 days
Submission Type Special
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
101d faster than avg
Panel avg: 129d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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

Beijing Believe-Med Technology Service Co., Ltd.
Ray Wang

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 K241970.
GenaCheck™ Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS/S/M/L/XL)
K240545 · Genabio Diagnostics, Inc. · Aug 2024
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
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