POWDER-FREE VINYL EXAMINATION GLOVES— 510(k) K081658

Name: FDA 510(k) clearance K081658
Creator: U.S. Food and Drug Administration
Published: 2008-09-30

Substantially Equivalent

Jiangsu Alfa Glove Co., Ltd.

FDA 510(k) clearance K081658 for POWDER-FREE VINYL EXAMINATION GLOVES, Substantially Equivalent on 2008-09-30. Applicant: Jiangsu Alfa Glove Co., Ltd.. Device class: 1.

Clearance details

Applicant: Jiangsu Alfa Glove Co., Ltd.
Product code: Code LYZ
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 2008-06-12
Decision date: 2008-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Haidian Dis, Beijing, 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 Alfa Glove Co., Ltd.

view all

K111459 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR2011-06-16

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