Nitrile examination gloves— 510(k) K211927

Clearance details

Applicant

Fitone Latex Products Co., Ltd. Guangdong

Product code

Code LZA

Device class

Class 1

Regulation

21 CFR 880.6250

Advisory panel

General Hospital

Date received

2021-06-22

Decision date

2021-10-12

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Zhanjiang, CN

• K261793 — Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color)2026-09-09
• K262542 — Biodegradable Nitrile Powder Free Examination Glove, Green +1 more2026-09-09
• K260312 — Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim +1 more2026-09-08
• K260794 — NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT AND UREA, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, FENTANYL CITRATE, XYLAZINE HCl, AND GASTRIC ACID. OCEAN COLOR2026-08-18
• K262014 — PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam Gloves2026-07-21

• K231446 — Single-Use Latex Sterile Surgical Gloves (SG100)2023-09-22
• K221747 — Nitrile Patient Examination Gloves Tested For Use With Chemotherapy Drugs2022-12-01
• K222693 — Single-use medical latex examination gloves (LG100)2022-09-24

Other

1

Total

1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →