FYA · Gown, Surgical · Chrysalis Intelligence

Device class

Class II

Regulation 878.4040

Total clearances

2020-03-16 → 2026-08-07

Last 12 months

Unique sponsors

Classification details

Medical specialty

General, Plastic Surgery

Review panel

Regulation number

878.4040

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Foshan Nanhai Plus Medical Co, Ltd.	4	0	2022-11-14
Medline Industries, LP	3	0	2025-02-26
Cardinal Health200, LLC	3	0	2023-07-27
Yadu Medical (Henan) Co., Ltd.	3	3	2026-08-07
O&M Halyard, Inc.	2	0	2021-07-21
Wujiang Tutaike Textiles & Finishing Co., Ltd.	2	0	2022-03-04
Xuchang Zhengde Environstar Medical Products Co., Ltd.	2	0	2022-12-21
Winner Medical Co., Ltd.	1	0	2022-09-19
Thi Total Healthcare Innovation GmbH	1	0	2025-05-30
Sejong Healthcare Co., Ltd.	1	0	2023-02-10
Unicoglobal, Inc.	1	0	2021-12-10
Standard Textile Co., Inc.	1	0	2024-09-10
Wuhan Dymex Healthcare Co., Ltd.	1	0	2021-10-18
Henan Yadu Industrial Co., Ltd.	1	0	2022-10-07
Weihai Hongyu Nonwoven Fabric Products Co., Ltd.	1	0	2022-04-12
Dukal Corporation	1	0	2022-03-18
Henan Robestain Medical Products Co., Ltd.	1	0	2021-12-13
Xiamen Probtain Medical Techology Co., Ltd.	1	0	2023-03-07
Nanning Tecbod Biological Technology Co., Ltd.	1	0	2024-03-29
Copioumed International, Inc.	1	1	2026-02-26
Hubei Woozon Healthcare Co., Ltd.	1	0	2023-06-16
Xiantao Rhycom Non-Woven Products Co., Ltd.	1	0	2022-10-28
Xianning Marveldas Protective Articles Co., Ltd.	1	0	2022-11-16
Jiangsu Medplus Non-Woven Manufacturer Co., Ltd.	1	0	2021-07-02
Feliks Plastik Laminasyon VE Ambalaj Malzemeleri Sanayi	1	0	2022-02-24

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
A4920	HCPCS	—	High	Standard HCPCS code for surgical gowns

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-08-07	K261028	Yadu Medical (Henan) Co., Ltd.	Surgical Gown Level2 (S, M, L, XL, XXL, XXXL)
2026-07-10	K261949	New York Embroidery Studio	NYES Tuff Cuff L3 Disposable Gowns
2026-06-04	K252575	New York Embroidery Studio (NYES)	Tuff Cuff Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)
2026-05-12	K260725	Hindernis DE Mexico, S.A.P.I. DE C.V.	BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)
2026-04-28	K253243	Cardinal Health 200, LLC	Cardinal Health Poly Reinforced Surgical Gown
2026-04-20	K253003	Hubei Xinxin Non-Woven Co., Ltd.	Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025); Non-sterile Reinforced Level 4 Surgical Gown (G4025); Reinforced Sterile Level 4 Surgical Gown (GM4025)
2026-02-26	K251860	Copioumed International, Inc.	Copioumed AAMI 3 Surgical Gown
2026-02-04	K252301	Yadu Medical (Henan) Co., Ltd.	Henan Yadu Level 4 Surgical Gowns (Reinforced)
2025-12-03	K250564	Yadu Medical (Henan) Co., Ltd.	Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL)
2025-05-30	K243522	Thi Total Healthcare Innovation GmbH	ViVi® Toga Premium
2025-05-05	K242937	Dae Myung Chemical Co., Ltd. (Vietnam)	Dream Medi Sterile Surgical Gown (SurgicalGownUL)
2025-02-26	K242844	Medline Industries, LP	Medline Level 4 Surgical Gown with Breathable Sleeves
2024-10-16	K241272	Stryker Instruments	Stryker Steri-Shield 8 Surgical Hoods and Togas
2024-09-10	K241214	Standard Textile Co., Inc.	ProPel SG3 Surgical Gown
2024-08-02	K233571	George Courey, Inc.	GCI Surgical Gown
2024-03-29	K233068	Nanning Tecbod Biological Technology Co., Ltd.	Disposable Surgical Gown
2024-02-01	K233183	Ammex-Weida (Hubei) Health and Safety Products Co., Ltd.	Surgical Gown (40083)
2023-10-12	K230707	Skypro Medical Supplies Company	Skypro, Surgical Gown 6021
2023-08-23	K230610	Dongguan Shin YI Healthcare Products Factory	Disposable Surgical Gown (Level 3, MF2103 Series), Disposable Surgical Gown (Level 3, MF2104 Series), Disposable Surgical Gown (Level 4, MF2105 Series)
2023-08-22	K231510	Xiantao Zhibo Non-Woven Products Co., Ltd.	Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S,M,L,XL,XXL,XXXL)
2023-08-16	K230577	Medcare Saglik Urunleri Sanayi VE Ticaret Anonim Sirketi	Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL)
2023-07-27	K230838	Cardinal Health200, LLC	Cardinal Health SmartGown EDGE Breathable Surgical Gown with ASSIST Instrument Pockets
2023-06-16	K222999	Hubei Woozon Healthcare Co., Ltd.	Surgical Gown
2023-03-12	K222456	3A Medical Products Co., Ltd.	High Protection Surgical Gown
2023-03-07	K223401	Xiamen Probtain Medical Techology Co., Ltd.	Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL)