Cleared Traditional

Paneffort AAMI Level 3 Isolation Gown

K212717 · Paneffort, LLC · General Hospital
Nov 2022
Decision
460d
Days
Class 2
Risk

About This 510(k) Submission

K212717 is an FDA 510(k) clearance for the Paneffort AAMI Level 3 Isolation Gown, a Gown, Isolation, Surgical (Class II — Special Controls, product code FYC), submitted by Paneffort, LLC (Rochester,, US). The FDA issued a Cleared decision on November 30, 2022, 460 days after receiving the submission on August 27, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number K212717 FDA.gov
FDA Decision Cleared SESE
Date Received August 27, 2021
Decision Date November 30, 2022
Days to Decision 460 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FYC — Gown, Isolation, Surgical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4040

Similar Devices — FYC Gown, Isolation, Surgical

All 67
Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311)
K232849 · Owens & Minor (O&M) Halyard, Inc. · May 2024
Copioumed Chemotherapy Isolation Gown
K230135 · Copioumed International, Inc. · Oct 2023
Disposable Isolation Gown
K223467 · Nanning Tecbod Biological Technology Co., Ltd. · Feb 2023
Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)
K223304 · Xiamen Probtain Medical Technology Co., Ltd. · Feb 2023
Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)
K223411 · Xiamen Probtain Medical Techology Co., Ltd. · Jan 2023
CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo Gown
K210414 · Medtecs (Taiwan) Corp. · Oct 2022