Cleared Abbreviated

K182308 - Non-Sterile, Powder-Free Nitrile Examination Glove Pink Tested for use with Chemotherapy Drugs (FDA 510(k) Clearance)

Class I General Hospital device.

K182308 · Sri Trang Gloves (Thailand) Co., Ltd. · General Hospital
May 2019
Decision
279d
Days
Class 1
Risk

K182308 is an FDA 510(k) clearance for the Non-Sterile, Powder-Free Nitrile Examination Glove Pink Tested for use with Chemotherapy Drugs. This device is classified as a Polymer Patient Examination Glove (Class I - General Controls, product code LZA).

Submitted by Sri Trang Gloves (Thailand) Co., Ltd. (Hatyai, TH). The FDA issued a Cleared decision on May 30, 2019, 279 days after receiving the submission on August 24, 2018.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6250. 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..

Submission Details

510(k) Number K182308 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2018
Decision Date May 30, 2019
Days to Decision 279 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Statement
Regulatory Context
Review time vs. panel average
110d slower than avg
Panel avg: 169d · This submission: 279d
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 Peers - LZA Polymer Patient Examination Glove

All 50
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K182308.
Syntex Exam Gloves
K253160 · Basic Medical Technology, Inc. · Jan 2026
Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid
K252549 · Kossan International Sdn Bhd · Jan 2026
Powder Free Nitrile Patient Examination Glove, Blue colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
K251141 · Mercator Medical (Thailand), Ltd. · Nov 2025
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (Black)
K250861 · Hartalega NGC Sdn. Bhd. · Oct 2025
Program insite® Powder-Free, Disposable Nitrile Exam Gloves
K252075 · Program Insite, LLC · Oct 2025
Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate
K251716 · Basic Medical Technology, Inc. · Aug 2025