Synthetic Nitrile Examination Gloves— 510(k) K212488

Name: FDA 510(k) clearance K212488
Creator: U.S. Food and Drug Administration
Published: 2021-11-26

Substantially Equivalent

Shandong Hongxin Chemicals Co., Ltd.

FDA 510(k) clearance K212488 for Synthetic Nitrile Examination Gloves, Substantially Equivalent on 2021-11-26. Applicant: Shandong Hongxin Chemicals Co., Ltd.. Device class: 1.

Clearance details

Applicant: Shandong Hongxin Chemicals Co., Ltd.
Product code: Code LYZ
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 2021-08-09
Decision date: 2021-11-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zibo, 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 Shandong Hongxin Chemicals Co., Ltd.

view all

K122828 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED)2012-12-10

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