FYC · Gown, Isolation, Surgical · Chrysalis Intelligence

Device class

Class II

Regulation 878.4040

Total clearances

2020-01-17 → 2024-05-16

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	Most recent
Hubei Xinxin Non-Woven Co., Ltd.	2	2022-10-11
Nanning Tecbod Biological Technology Co., Ltd.	1	2023-02-10
String King Lacrosse, LLC	1	2021-11-24
Crown Name Disposable Hygiene Products Fty., Ltd.	1	2022-04-29
Wuhan Zonsen Medical Products Co., Ltd.	1	2022-01-20
Chongqing Litai Fashion Group Limited Company	1	2021-11-13
Flomak Tekstil Makine Muh. Mum. Taah. San. Tic. Ltd. Sti.	1	2022-04-13
Xiamen Probtain Medical Technology Co., Ltd.	1	2023-02-08
Kenpax International Limited	1	2021-11-07
Xiamen Probtain Medical Techology Co., Ltd.	1	2023-01-04
Copioumed International, Inc.	1	2023-10-04
Foshan Nanhai Plus Medical Co, Ltd.	1	2022-03-02
Allmed Medical (Hubei) Protective Products Co., Ltd.	1	2022-08-12
Medtecs (Taiwan) Corp.	1	2022-10-21
Wildcat Ppe, LLC	1	2021-01-29
Wuhan Dymex Healthcare Co., Ltd.	1	2022-06-10
Gri-Alleset, Inc.	1	2021-08-26
Owens & Minor (O&M) Halyard, Inc.	1	2024-05-16
Azac Group	1	2021-11-17
Amd Medicom, Inc.	1	2020-01-17
Yanbian Pacific Textile Co., Ltd.	1	2021-05-20
Paneffort, LLC	1	2022-11-30

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 isolation/surgical gowns

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2024-05-16	K232849	Owens & Minor (O&M) Halyard, Inc.	Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311)
2023-10-04	K230135	Copioumed International, Inc.	Copioumed Chemotherapy Isolation Gown
2023-02-10	K223467	Nanning Tecbod Biological Technology Co., Ltd.	Disposable Isolation Gown
2023-02-08	K223304	Xiamen Probtain Medical Technology Co., Ltd.	Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)
2023-01-04	K223411	Xiamen Probtain Medical Techology Co., Ltd.	Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)
2022-11-30	K212717	Paneffort, LLC	Paneffort AAMI Level 3 Isolation Gown
2022-10-21	K210414	Medtecs (Taiwan) Corp.	CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo Gown
2022-10-11	K214116	Hubei Xinxin Non-Woven Co., Ltd.	AAMI4 Isolation Gown
2022-08-12	K221027	Allmed Medical (Hubei) Protective Products Co., Ltd.	Isolation Gown (S, M, L, XL, XXL (Yellow, Blue))
2022-06-10	K220528	Wuhan Dymex Healthcare Co., Ltd.	Surgical Isolation Cover Gown
2022-05-16	K213832	Hubei Xinxin Non-Woven Co., Ltd.	AAMI3 Isolation Gown
2022-04-29	K212422	Crown Name Disposable Hygiene Products Fty., Ltd.	Disposable Surgical Isolation Gown
2022-04-13	K210148	Flomak Tekstil Makine Muh. Mum. Taah. San. Tic. Ltd. Sti.	Flosteril Poly-reinforced Isolation Gowns Model 8120 (Catalogue Number 8120400), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120410), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120430), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120450), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120460)
2022-03-02	K212698	Foshan Nanhai Plus Medical Co, Ltd.	Plus Medical Isolation Gown Level 3
2022-01-20	K212357	Wuhan Zonsen Medical Products Co., Ltd.	Surgical isolation gown
2021-11-24	K212633	String King Lacrosse, LLC	Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, Blue
2021-11-17	K211538	Azac Group	Protect X Level 3 Isolation Gown
2021-11-13	K210785	Chongqing Litai Fashion Group Limited Company	Disposable Surgical Gowns
2021-11-07	K212504	Kenpax International Limited	Isolation Gown AAMI Level 3
2021-08-26	K210131	Gri-Alleset, Inc.	ComfortGuard Surgical Isolation Gown
2021-05-20	K203415	Yanbian Pacific Textile Co., Ltd.	Surgical Isolation Gown
2021-01-29	K202310	Wildcat Ppe, LLC	Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full Back
2020-01-17	K190306	Amd Medicom, Inc.	AMD Ritmed AssureWear VersaGown