POWDER FREE VINYL EXAMINATION GLOVE— 510(k) K052985

Name: FDA 510(k) clearance K052985
Creator: U.S. Food and Drug Administration
Published: 2006-01-19

Substantially Equivalent

Tg Medical (China) Incorporation

FDA 510(k) clearance K052985 for POWDER FREE VINYL EXAMINATION GLOVE, Substantially Equivalent on 2006-01-19. Applicant: Tg Medical (China) Incorporation. Device class: 1.

Clearance details

Applicant: Tg Medical (China) Incorporation
Product code: Code LYZ
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 2005-10-24
Decision date: 2006-01-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zhangjiagang, Jiangsu Province, 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 Tg Medical (China) Incorporation

view all

K052984 — POWDERED VINYL EXAMINATION GLOVE2006-01-11

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