Cleared Traditional

Nitrile Patient Examination Gloves Tested For Use With Chemotherapy Drugs

K221747 · Fitone Latex Products Co., Ltd. Guangdong · General Hospital
Dec 2022
Decision
168d
Days
Class 1
Risk

About This 510(k) Submission

K221747 is an FDA 510(k) clearance for the Nitrile Patient Examination Gloves Tested For Use With Chemotherapy Drugs, a Polymer Patient Examination Glove (Class I — General Controls, product code LZA), submitted by Fitone Latex Products Co., Ltd. Guangdong (Zhanjiang, CN). The FDA issued a Cleared decision on December 1, 2022, 168 days after receiving the submission on June 16, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number K221747 FDA.gov
FDA Decision Cleared SESE
Date Received June 16, 2022
Decision Date December 01, 2022
Days to Decision 168 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code LZA — Polymer Patient Examination Glove
Device Class Class I — 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.

Similar Devices — LZA Polymer Patient Examination Glove

All 1167
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; Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Blue), 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; Powder Free Nitrile Patient Examination Glove, Black 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