Cleared Traditional

DISPOSABLE SURGICAL GOWNS

K120192 · Weihai Hongyu Nonwoven Fabric Products Co., Ltd. · General Hospital
Oct 2012
Decision
267d
Days
Class 2
Risk

About This 510(k) Submission

K120192 is an FDA 510(k) clearance for the DISPOSABLE SURGICAL GOWNS, a Gown, Surgical (Class II — Special Controls, product code FYA), submitted by Weihai Hongyu Nonwoven Fabric Products Co., Ltd. (Weihai, KM). The FDA issued a Cleared decision on October 16, 2012, 267 days after receiving the submission on January 23, 2012. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number K120192 FDA.gov
FDA Decision Cleared SESE
Date Received January 23, 2012
Decision Date October 16, 2012
Days to Decision 267 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

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

Similar Devices — FYA Gown, Surgical

All 290
Copioumed AAMI 3 Surgical Gown
K251860 · Copioumed International, Inc. · Feb 2026
Henan Yadu Level 4 Surgical Gowns (Reinforced)
K252301 · Yadu Medical (Henan) Co., Ltd. · Feb 2026
Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL)
K250564 · Yadu Medical (Henan) Co., Ltd. · Dec 2025
ViVi? Toga Premium
K243522 · Thi Total Healthcare Innovation GmbH · May 2025
Dream Medi Sterile Surgical Gown (SurgicalGownUL)
K242937 · Dae Myung Chemical Co., Ltd. (Vietnam) · May 2025
Medline Level 4 Surgical Gown with Breathable Sleeves
K242844 · Medline Industries, LP · Feb 2025