Cleared Traditional

Powder Free Nitrile Examination Glove, Pink Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K232461) - FDA 510(k) Clearance

Also marketed or referenced as:
Powder Free Nitrile Examination Glove, Orange Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Powder Free Nitrile Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Powder Free Nitrile Examination Glove, Black Colored, Non-Sterile, Low Dermatitis

Class I General Hospital device.

K232461 · Kossan International Sdn Bhd · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2023
Decision
91d
Days
Class 1
Risk

K232461 is an FDA 510(k) clearance for the Powder Free Nitrile Examination Glove, Pink Colored, Non-Sterile, Tested for .... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Kossan International Sdn Bhd (Klang, MY). The FDA issued a Cleared decision on November 14, 2023 after a review of 91 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Kossan International Sdn Bhd devices

Submission Details

510(k) Number K232461 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2023
Decision Date November 14, 2023
Days to Decision 91 days
Submission Type Traditional
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
38d faster than avg
Panel avg: 129d · This submission: 91d
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 K232461.
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black), Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Orange)
K232252 · Dehai (Shandong) Medical Gloves, Co., Ltd. · Nov 2023
Medical Nitrile Examination Gloves
K232576 · Jiangsu Complete Sincerity Medical New Materials Co., Ltd. · Nov 2023
DUAL COLOR NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS AND FENTANYL
K232538 · Wrp Asia Pacific Sdn. Bhd. · Nov 2023
Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
K232266 · Better Care Plastic Technology Co., Ltd. · Nov 2023
Nitrile Exam Glove, Tested For Use With Chemotherapy Drugs And Fentanyl
K231029 · Zhonghong Pulin Medical Products Co., Ltd. · Oct 2023
Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, And Select Other Drugs
K230662 · Zhonghong Pulin Medical Products Co., Ltd. · Oct 2023