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510(k) K213177

Plus Medical Cover Gown by Foshan Nanhai Plus Medical Co, Ltd. — Product Code FYA

K213177 is an FDA 510(k) premarket notification submitted by Foshan Nanhai Plus Medical Co, Ltd. for the device "Plus Medical Cover Gown". The FDA issued a decision of Substantially Equivalent on May 11, 2022. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040. Foshan Nanhai Plus Medical Co, Ltd. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 2022
Date Received
September 28, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gown, Surgical
Device Class
Class II
Regulation Number
878.4040
Review Panel
HO
Submission Type

Other clearances by Foshan Nanhai Plus Medical Co, Ltd.

  • K222480 — Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2) (November 14, 2022)
  • K211036 — Plus Medical Chemotherapy Gown (May 4, 2022)
  • K212698 — Plus Medical Isolation Gown Level 3 (March 2, 2022)
  • K212610 — Surgical Face Mask (January 26, 2022)
  • K210143 — Standard Surgical Gown (AAMI Level 3), Reinforced Surgical Gown (AAMI Level 3) (July 22, 2021)
  • K133075 — Plus Surgical Gowns (EO Sterilized), PMGB-XXX (June 24, 2015)
  • K133080 — Plus Surgical Drapes (EO Sterilized), PMDB-XXX (June 24, 2015)

Other clearances for product code FYA

  • K260407 — Principle & Will ANSI/AAMI PB 70 (Sterile/Non-sterile) Level 3 Surgical Gowns (R (August 26, 2026)
  • K261028 — Surgical Gown Level2 (S, M, L, XL, XXL, XXXL) (August 7, 2026)
  • K261949 — NYES Tuff Cuff L3 Disposable Gowns (July 10, 2026)
  • K252575 — Tuff Cuff™ Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L) (June 4, 2026)
  • K260725 — BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10) (May 12, 2026)
  • K253243 — Cardinal Health™ Poly Reinforced Surgical Gown (April 28, 2026)
  • K253003 — Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025); (April 20, 2026)
  • K251860 — Copioumed AAMI 3 Surgical Gown (February 26, 2026)
  • K252301 — Henan Yadu Level 4 Surgical Gowns (Reinforced) (February 4, 2026)
  • K250564 — Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL) (December 3, 2025)

FDA data resources