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510(k) K223467

Disposable Isolation Gown by Nanning Tecbod Biological Technology Co., Ltd. — Product Code FYC

K223467 is an FDA 510(k) premarket notification submitted by Nanning Tecbod Biological Technology Co., Ltd. for the device "Disposable Isolation Gown". The FDA issued a decision of Substantially Equivalent on February 10, 2023. The device falls under product code FYC (Gown, Isolation, Surgical), a Class II device regulated under 21 CFR 878.4040. Nanning Tecbod Biological Technology Co., Ltd. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 2023
Date Received
November 17, 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 Nanning Tecbod Biological Technology Co., Ltd.

  • K233068 — Disposable Surgical Gown (March 29, 2024)

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)
  • K223304 — Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) (February 8, 2023)
  • K223411 — Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) (January 4, 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