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510(k) K214116

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

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.

  • K213832 — AAMI3 Isolation Gown (May 16, 2022)
  • K212120 — Surgical Masks (January 28, 2022)

Other clearances for product code FYC

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  • 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)