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510(k) K220528

Surgical Isolation Cover Gown by Wuhan Dymex Healthcare Co., Ltd. — Product Code FYC

K220528 is an FDA 510(k) premarket notification submitted by Wuhan Dymex Healthcare Co., Ltd. for the device "Surgical Isolation Cover Gown". The FDA issued a decision of Substantially Equivalent on June 10, 2022. The device falls under product code FYC (Gown, Isolation, Surgical), a Class II device regulated under 21 CFR 878.4040. Wuhan Dymex Healthcare Co., Ltd. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 2022
Date Received
February 24, 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 Wuhan Dymex Healthcare Co., Ltd.

  • K211809 — Surgical Gown (October 18, 2021)
  • K210433 — Surgical Face Mask (Ear loops and Tie-on) (June 7, 2021)
  • K182515 — Surgical Face Mask (May 27, 2019)

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)
  • K213832 — AAMI3 Isolation Gown (May 16, 2022)

FDA data resources