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510(k) K212504

Isolation Gown AAMI Level 3 by Kenpax International Limited — Product Code FYC

K212504 is an FDA 510(k) premarket notification submitted by Kenpax International Limited for the device "Isolation Gown AAMI Level 3". The FDA issued a decision of Substantially Equivalent on November 7, 2021. The device falls under product code FYC (Gown, Isolation, Surgical), a Class II device regulated under 21 CFR 878.4040. Kenpax International Limited has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 2021
Date Received
August 9, 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 Kenpax International Limited

  • K222128 — Protective Gown AAMI Level 4 (August 8, 2023)
  • K222151 — Sterilization Wrap (March 23, 2023)
  • K202899 — Procedure Mask, Surgical Mask (May 20, 2021)

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)
  • 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)

FDA data resources