510(k) K223304

Device: Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)
Applicant: Xiamen Probtain Medical Technology Co., Ltd.
510(k) number: K223304
Product code: FYC
Decision: Substantially Equivalent (SESE)
Decision date: 2023-02-08
Date received: 2022-10-27
Regulation: 878.4040
Classification name: Gown, Isolation, Surgical
Medical specialty: General, Plastic Surgery
Review panel: General, Plastic Surgery
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: N

Related Records

Applicant Contact

Contact: Jianli Kang
Address: 4th Floor, #1 Bldg., #6 Ji'An Rd., Tong'An District Xiamen CN 361100 361100

FDA Registration Numbers

3014925393
3004111573
3004158259
3016705853
3017171460
3017180923
3012344767
9681151
3014421917
3017494520
3016680688
1043214
3020755815
1054241
2320762
1921846
1933975
3010155681
3016844398
3026536498
1055236
1018470
3013260641
3015140351
3015960676
3016678045
3013502418
9680646
3006400329
3009540572
3015820879
3017597597
2648727
3017467279
3017896419
3016096096
3011547453
2433012
9611959
9680222
9614306
9616096
1417592
3004513970
1423537
3003495693
9615270
3006538071
3009750712
3013960812
3007838093
3021274073
3011545608
3003561450
3008959420
3016763307
1423205
3006723155

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code FYC

510(k)	Device	Applicant	Decision date
K232849	Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311)	Owens & Minor (O&M) Halyard, Inc.	2024-05-16
K230135	Copioumed Chemotherapy Isolation Gown	Copioumed International, Inc.	2023-10-04
K223467	Disposable Isolation Gown	Nanning Tecbod Biological Technology Co., Ltd.	2023-02-10
K223411	Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)	Xiamen Probtain Medical Techology Co., Ltd.	2023-01-04
K212717	Paneffort AAMI Level 3 Isolation Gown	Paneffort, LLC	2022-11-30
K210414	CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo Gown	Medtecs (Taiwan) Corp.	2022-10-21
K214116	AAMI4 Isolation Gown	Hubei Xinxin Non-Woven Co., Ltd.	2022-10-11
K221027	Isolation Gown (S, M, L, XL, XXL (Yellow, Blue))	Allmed Medical (Hubei) Protective Products Co., Ltd.	2022-08-12
K220528	Surgical Isolation Cover Gown	Wuhan Dymex Healthcare Co., Ltd.	2022-06-10
K213832	AAMI3 Isolation Gown	Hubei Xinxin Non-Woven Co., Ltd.	2022-05-16
K212422	Disposable Surgical Isolation Gown	Crown Name Disposable Hygiene Products Fty., Ltd.	2022-04-29
K210148	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)	Flomak Tekstil Makine Muh. Mum. Taah. San. Tic. Ltd. Sti.	2022-04-13
K212698	Plus Medical Isolation Gown Level 3	Foshan Nanhai Plus Medical Co, Ltd.	2022-03-02
K212357	Surgical isolation gown	Wuhan Zonsen Medical Products Co., Ltd.	2022-01-20
K212633	Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, Blue	String King Lacrosse, LLC	2021-11-24