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510(k) K171535

SURGICAL ISOLATION GOWN by Jingzhou Haixin Green Cross Medical Products Co., Ltd. — Product Code FYC

K171535 is an FDA 510(k) premarket notification submitted by Jingzhou Haixin Green Cross Medical Products Co., Ltd. for the device "SURGICAL ISOLATION GOWN". The FDA issued a decision of Substantially Equivalent on Feb 15, 2018. The device falls under product code FYC (Gown, Isolation, Surgical), a Class II device regulated under 21 CFR 878.4040. Jingzhou Haixin Green Cross Medical Products Co., Ltd. has 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Feb 15, 2018
Date Received
May 25, 2017
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
510(k)

Other clearances by Jingzhou Haixin Green Cross Medical Products Co., Ltd.

  • K222266 — Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80) (Sep 26, 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 (Oct 4, 2023)
  • K223467 — Disposable Isolation Gown (Feb 10, 2023)
  • K223304 — Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) (Feb 8, 2023)
  • K223411 — Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) (Jan 4, 2023)
  • K212717 — Paneffort AAMI Level 3 Isolation Gown (Nov 30, 2022)
  • K210414 — CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable… (Oct 21, 2022)
  • K214116 — AAMI4 Isolation Gown (Oct 11, 2022)
  • K221027 — Isolation Gown (S, M, L, XL, XXL (Yellow, Blue)) (Aug 12, 2022)
  • K220528 — Surgical Isolation Cover Gown (Jun 10, 2022)

FDA data resources