Cleared Traditional

Medical Surgical Gowns

K202844 · Beijing Biosis Healing Biolog Ical Technology Co., Ltd. · General Hospital
Jan 2021
Decision
103d
Days
Class 2
Risk

About This 510(k) Submission

K202844 is an FDA 510(k) clearance for the Medical Surgical Gowns, a Gown, Surgical (Class II — Special Controls, product code FYA), submitted by Beijing Biosis Healing Biolog Ical Technology Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on January 6, 2021, 103 days after receiving the submission on September 25, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number K202844 FDA.gov
FDA Decision Cleared SESE
Date Received September 25, 2020
Decision Date January 06, 2021
Days to Decision 103 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