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510(k) K212717

Paneffort AAMI Level 3 Isolation Gown by Paneffort, LLC — Product Code FYC

K212717 is an FDA 510(k) premarket notification submitted by Paneffort, LLC for the device "Paneffort AAMI Level 3 Isolation Gown". The FDA issued a decision of Substantially Equivalent on November 30, 2022. The device falls under product code FYC (Gown, Isolation, Surgical), a Class II device regulated under 21 CFR 878.4040. Paneffort, LLC has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 30, 2022
Date Received
August 27, 2021
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 Paneffort, LLC

  • K221409 — Paneffort 3-ply Surgical and Procedural Masks (July 25, 2022)

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