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510(k) K223411

Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) by Xiamen Probtain Medical Techology Co., Ltd. — Product Code FYC

K223411 is an FDA 510(k) premarket notification submitted by Xiamen Probtain Medical Techology Co., Ltd. for the device "Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)". The FDA issued a decision of Substantially Equivalent on January 4, 2023. The device falls under product code FYC (Gown, Isolation, Surgical), a Class II device regulated under 21 CFR 878.4040. Xiamen Probtain Medical Techology Co., Ltd. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 4, 2023
Date Received
November 9, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gown, Isolation, Surgical
Device Class
Class II
Regulation Number
878.4040
Review Panel
HO
Submission Type

Other clearances by Xiamen Probtain Medical Techology Co., Ltd.

  • K223401 — Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL) (March 7, 2023)
  • K202954 — Disposable Surgical Mask (July 2, 2021)
  • K201893 — Disposable Surgical Mask (December 9, 2020)

Other clearances for product code FYC

  • K232849 — Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI (May 16, 2024)
  • K230135 — Copioumed Chemotherapy Isolation Gown (October 4, 2023)
  • K223467 — Disposable Isolation Gown (February 10, 2023)
  • K223304 — Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) (February 8, 2023)
  • K212717 — Paneffort AAMI Level 3 Isolation Gown (November 30, 2022)
  • K210414 — CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable G (October 21, 2022)
  • K214116 — AAMI4 Isolation Gown (October 11, 2022)
  • K221027 — Isolation Gown (S, M, L, XL, XXL (Yellow, Blue)) (August 12, 2022)
  • K220528 — Surgical Isolation Cover Gown (June 10, 2022)
  • K213832 — AAMI3 Isolation Gown (May 16, 2022)

FDA data resources