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510(k) K221027

Isolation Gown (S, M, L, XL, XXL (Yellow, Blue)) by Allmed Medical (Hubei) Protective Products Co., Ltd. — Product Code FYC

K221027 is an FDA 510(k) premarket notification submitted by Allmed Medical (Hubei) Protective Products Co., Ltd. for the device "Isolation Gown (S, M, L, XL, XXL (Yellow, Blue))". The FDA issued a decision of Substantially Equivalent on August 12, 2022. The device falls under product code FYC (Gown, Isolation, Surgical), a Class II device regulated under 21 CFR 878.4040. Allmed Medical (Hubei) Protective Products Co., Ltd. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 2022
Date Received
April 6, 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 Allmed Medical (Hubei) Protective Products Co., Ltd.

  • K221637 — Surgical Gown (Sterile); Surgical Gown (Non-sterile) (September 29, 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)
  • 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)
  • K220528 — Surgical Isolation Cover Gown (June 10, 2022)
  • K213832 — AAMI3 Isolation Gown (May 16, 2022)

FDA data resources