Cleared Traditional

Aloe Vera Nitrile Examination Gloves (Green) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K240080) - FDA 510(k) Clearance

Class I General Hospital device.

K240080 · Syntex Healthcare Products Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2024
Decision
82d
Days
Class 1
Risk

K240080 is an FDA 510(k) clearance for the Aloe Vera Nitrile Examination Gloves (Green) Tested for Use with Chemotherapy.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Syntex Healthcare Products Co., Ltd. (Xinji, CN). The FDA issued a Cleared decision on April 2, 2024 after a review of 82 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 Syntex Healthcare Products Co., Ltd. devices

Submission Details

510(k) Number K240080 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 2024
Decision Date April 02, 2024
Days to Decision 82 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
47d faster than avg
Panel avg: 129d · This submission: 82d
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 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 K240080.
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
Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000)
K233990 · Shandong Xingyu Gloves Co., Ltd. · Apr 2024
Disposable Powder Free Nitrile Examination Glove, Natural Blue Color, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
K234097 · Ever Growth (Vietnam) Corporation Limited · Mar 2024
Halyard STERLING* Nitrile Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid
K231938 · O&M Halyard, Inc. · Mar 2024