Home / 510(k) Clearances / K190950

510(k) K190950

Medline Level 2 Surgical Gown (Eclipse Non-Reinforced), Medline Level 3 Surgical Gown (Eclipse Fabric Reinforced), Medline Level 3 Surgical Gown (Sirus Non-Reinforced), Medline Level 3 Surgical Gown (Sirus Fabric Reinforced), Medline Level 3 Surgical Gown (Aurora Non Reinforced & Aurora Fabric Reinforced) by Medline Industries, Inc. — Product Code FYA

K190950 is an FDA 510(k) premarket notification submitted by Medline Industries, Inc. for the device "Medline Level 2 Surgical Gown (Eclipse Non-Reinforced), Medline Level 3 Surgical Gown (Eclipse Fabric Reinforced), Medline Level 3 Surgical Gown (Sirus Non-Reinforced), Medline Level 3 Surgical Gown (Sirus Fabric Reinforced), Medline Level 3 Surgical Gown (Aurora Non Reinforced & Aurora Fabric Reinforced)". The FDA issued a decision of Substantially Equivalent on Jul 4, 2019. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040. Medline Industries, Inc. has 268 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jul 4, 2019
Date Received
Apr 11, 2019
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
510(k)

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Other clearances for product code FYA

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  • K261949 — NYES Tuff Cuff L3 Disposable Gowns (Jul 10, 2026)
  • K252575 — Tuff Cuff™ Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L) (Jun 4, 2026)
  • K260725 — BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10) (May 12, 2026)
  • K253243 — Cardinal Health™ Poly Reinforced Surgical Gown (Apr 28, 2026)
  • K253003 — Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025)… (Apr 20, 2026)
  • K251860 — Copioumed AAMI 3 Surgical Gown (Feb 26, 2026)
  • K252301 — Henan Yadu Level 4 Surgical Gowns (Reinforced) (Feb 4, 2026)
  • K250564 — Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL) (Dec 3, 2025)

FDA data resources