Vinyl Examination Gloves— 510(k) K213006

Name: FDA 510(k) clearance K213006
Creator: U.S. Food and Drug Administration
Published: 2021-12-21

Substantially Equivalent

Taian Hengchang Medical Technology Co., Ltd.

FDA 510(k) clearance K213006 for Vinyl Examination Gloves, Substantially Equivalent on 2021-12-21. Applicant: Taian Hengchang Medical Technology Co., Ltd.. Device class: 1.

Clearance details

Applicant: Taian Hengchang Medical Technology Co., Ltd.
Product code: Code LYZ
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 2021-09-20
Decision date: 2021-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taian City, 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

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