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510(k) K230135

Device
Copioumed Chemotherapy Isolation Gown
Applicant
Copioumed International, Inc.
510(k) number
K230135
Product code
FYC
Decision
Substantially Equivalent (SESE)
Decision date
2023-10-04
Date received
2023-01-18
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
No

Applicant Contact#

Contact
James Liu
Address
16f-4, #1, Fuxing N. Rd., Songshan Dist. Taipei City TW 105 105

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FYC#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K232849Halyard 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
K223467Disposable Isolation GownNanning Tecbod Biological Technology Co., Ltd.2023-02-10
K223304Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)Xiamen Probtain Medical Technology Co., Ltd.2023-02-08
K223411Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)Xiamen Probtain Medical Techology Co., Ltd.2023-01-04
K212717Paneffort AAMI Level 3 Isolation GownPaneffort, LLC2022-11-30
K210414CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo GownMedtecs (Taiwan) Corp.2022-10-21
K214116AAMI4 Isolation GownHubei Xinxin Non-Woven Co., Ltd.2022-10-11
K221027Isolation Gown (S, M, L, XL, XXL (Yellow, Blue))Allmed Medical (Hubei) Protective Products Co., Ltd.2022-08-12
K220528Surgical Isolation Cover GownWuhan Dymex Healthcare Co., Ltd.2022-06-10
K213832AAMI3 Isolation GownHubei Xinxin Non-Woven Co., Ltd.2022-05-16
K212422Disposable Surgical Isolation GownCrown Name Disposable Hygiene Products Fty., Ltd.2022-04-29
K210148Flosteril 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
K212698Plus Medical Isolation Gown Level 3Foshan Nanhai Plus Medical Co, Ltd.2022-03-02
K212357Surgical isolation gownWuhan Zonsen Medical Products Co., Ltd.2022-01-20
K212633Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, BlueString King Lacrosse, LLC2021-11-24