Vinyl Patient Examination Gloves— 510(k) K182115

Name: FDA 510(k) clearance K182115
Creator: U.S. Food and Drug Administration
Published: 2018-10-03

Substantially Equivalent

Pingan Medical Products Co., Ltd.

FDA 510(k) clearance K182115 for Vinyl Patient Examination Gloves, Substantially Equivalent on 2018-10-03. Applicant: Pingan Medical Products Co., Ltd.. Device class: 1.

Clearance details

Applicant: Pingan Medical Products Co., Ltd.
Product code: Code LYZ
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 2018-08-06
Decision date: 2018-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jiu Jiang, 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 Pingan Medical Products Co., Ltd.

view all

K222527 — Nitrile Patient Examination Glove2022-12-14
K210725 — Nitrile Patient Examination Glove2021-08-06

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