Disposable Isolation Gown— 510(k) K223467

Name: FDA 510(k) clearance K223467
Creator: U.S. Food and Drug Administration
Published: 2023-02-10

Substantially Equivalent

Nanning Tecbod Biological Technology Co., Ltd.

FDA 510(k) clearance K223467 for Disposable Isolation Gown, Substantially Equivalent on 2023-02-10. Applicant: Nanning Tecbod Biological Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Nanning Tecbod Biological Technology Co., Ltd.
Product code: Code FYC
Device class: Class 2
Regulation: 21 CFR 878.4040
Advisory panel: General, Plastic Surgery
Date received: 2022-11-17
Decision date: 2023-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Naning, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code FYC

view all

K232849 — Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311)2024-05-16
K230135 — Copioumed Chemotherapy Isolation Gown2023-10-04
K223304 — Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)2023-02-08
K223411 — Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)2023-01-04
K212717 — Paneffort AAMI Level 3 Isolation Gown2022-11-30

More clearances from Nanning Tecbod Biological Technology Co., Ltd.

view all

K233068 — Disposable Surgical Gown2024-03-29

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