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FYC — Gown, Isolation, Surgical Class II

FDA Device Classification

Classification Details

Product Code
FYC
Device Class
Class II
Regulation Number
878.4040
Submission Type
Review Panel
HO
Medical Specialty
General, Plastic Surgery
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K232849owens and minor (o and m) halyardHalyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMIMay 16, 2024
K230135copioumed internationalCopioumed Chemotherapy Isolation GownOctober 4, 2023
K223467nanning tecbod biological technology coDisposable Isolation GownFebruary 10, 2023
K223304xiamen probtain medical technology coDisposable Isolation Gowns (S,M,L,XL,XXL,XXXL)February 8, 2023
K223411xiamen probtain medical techology coDisposable Isolation Gowns (S,M,L,XL,XXL,XXXL)January 4, 2023
K212717paneffortPaneffort AAMI Level 3 Isolation GownNovember 30, 2022
K210414medtecs (taiwan)CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable GOctober 21, 2022
K214116hubei xinxin non-woven coAAMI4 Isolation GownOctober 11, 2022
K221027allmed medical (hubei) protective products coIsolation Gown (S, M, L, XL, XXL (Yellow, Blue))August 12, 2022
K220528wuhan dymex healthcare coSurgical Isolation Cover GownJune 10, 2022
K213832hubei xinxin non-woven coAAMI3 Isolation GownMay 16, 2022
K212422crown name disposable hygiene products ftyDisposable Surgical Isolation GownApril 29, 2022
K210148flomak tekstil makine muh. mum. taah. san. tic. ltd. stiFlosteril Poly-reinforced Isolation Gowns Model 8120 (Catalogue Number 8120400),April 13, 2022
K212698foshan nanhai plus medical coPlus Medical Isolation Gown Level 3March 2, 2022
K212357wuhan zonsen medical products coSurgical isolation gownJanuary 20, 2022
K212633string king lacrosseDisposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - LevNovember 24, 2021
K211538azac groupProtect X Level 3 Isolation GownNovember 17, 2021
K210785chongqing litai fashion group limitedDisposable Surgical GownsNovember 13, 2021
K212504kenpax international limitedIsolation Gown AAMI Level 3November 7, 2021
K210131gri-allesetComfortGuard Surgical Isolation GownAugust 26, 2021