Synthetic Vinyl Examination Gloves— 510(k) K211045

Name: FDA 510(k) clearance K211045
Creator: U.S. Food and Drug Administration
Published: 2021-06-23

Substantially Equivalent

Jiangsu Huayuan Medical Technology Co., Ltd.

FDA 510(k) clearance K211045 for Synthetic Vinyl Examination Gloves, Substantially Equivalent on 2021-06-23. Applicant: Jiangsu Huayuan Medical Technology Co., Ltd.. Device class: 1.

Clearance details

Applicant: Jiangsu Huayuan Medical Technology Co., Ltd.
Product code: Code LYZ
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 2021-04-08
Decision date: 2021-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dongtai, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code LYZ

view all

K260860 — Powder Free Synthetic Vinyl Exam Gloves (Blue, Black)2026-04-07
K252467 — Disposable Vinyl Examination Gloves2025-10-27
K252505 — Powder-Free Vinyl Exam Gloves, clear2025-08-28
K241252 — Disposable Vinyl Examination Gloves2024-05-20
K230046 — Vinyl examination gloves2023-03-25

More clearances from Jiangsu Huayuan Medical Technology Co., Ltd.

view all

K213044 — Nitrile Examination Gloves2022-01-21

Data sourced from openFDA. This site is unofficial and independent of the FDA.