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510(k) K214116

AAMI4 Isolation Gown by Hubei Xinxin Non-Woven Co., Ltd. — Product Code FYC

K214116 is an FDA 510(k) premarket notification submitted by Hubei Xinxin Non-Woven Co., Ltd. for the device "AAMI4 Isolation Gown". The FDA issued a decision of Substantially Equivalent on October 11, 2022. The device falls under product code FYC (Gown, Isolation, Surgical), a Class II device regulated under 21 CFR 878.4040. Hubei Xinxin Non-Woven Co., Ltd. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 11, 2022
Date Received
December 30, 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 Hubei Xinxin Non-Woven Co., Ltd.

  • K253003 — Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025); (April 20, 2026)
  • K213832 — AAMI3 Isolation Gown (May 16, 2022)
  • K212120 — Surgical Masks (January 28, 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)
  • 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