POWDER-FREE VINYL PATIENT EXAMINATION GLOVES— 510(k) K093276

Name: FDA 510(k) clearance K093276
Creator: U.S. Food and Drug Administration
Published: 2009-11-04

Substantially Equivalent

Tangshan Kangyuan Glove Co., Ltd.

FDA 510(k) clearance K093276 for POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, Substantially Equivalent on 2009-11-04. Applicant: Tangshan Kangyuan Glove Co., Ltd.. Device class: 1.

Clearance details

Applicant: Tangshan Kangyuan Glove Co., Ltd.
Product code: Code LYZ
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 2009-10-19
Decision date: 2009-11-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beijing, CN

Download summary PDF View on FDA.gov ↗

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Recalls naming K093276

K-number listed on FDA's recall record

Z-2828-2018 — Powder Free Vinyl Exam Gloves, Item Nos. 14-116, 14-118 Product Usage: Medical exam glove for use by professional healthcare workers and/or consumers.Class II·Terminated·Cypress Medical Products LLC·20180702

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K093276.

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