Surgical Procedure Packs

FDA 510(k) K110724 · Omnia Spa

Substantially Equivalent

510(k) numberK110724

Submission

Device name
Surgical Procedure Packs
Applicant
Omnia Spa
Carmel, IN, US
Received
March 16, 2011
Decision date
June 23, 2011
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FYA – Gown, Surgical
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4040
Specialty
General, Plastic Surgery

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K261028Surgical Gown Level2 (S, M, L, XL, XXL, XXXL)FYA · Traditional Yadu Medical (Henan) Co., Ltd.08/07/2026SE
K261949NYES Tuff Cuff L3 Disposable GownsFYA · Special New York Embroidery Studio07/10/2026SE
K252575Tuff Cuff™ Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)FYA · Traditional New York Embroidery Studio (NYES)06/04/2026SE
K260725BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)FYA · Traditional Hindernis DE Mexico, S.A.P.I. DE C.V.05/12/2026SE
K253243Cardinal Health™ Poly Reinforced Surgical GownFYA · Abbreviated Cardinal Health 200, LLC04/28/2026SE
K253003Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025)…FYA · Traditional Hubei Xinxin Non-Woven Co., Ltd.04/20/2026SE
K251860Copioumed AAMI 3 Surgical GownFYA · Traditional Copioumed International, Inc.02/26/2026SE
K252301Henan Yadu Level 4 Surgical Gowns (Reinforced)FYA · Traditional Yadu Medical (Henan) Co., Ltd.02/04/2026SE
K250564Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL)FYA · Traditional Yadu Medical (Henan) Co., Ltd.12/03/2025SE

More from Yadu Medical (Henan) Co., Ltd.

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Questions and answers

When was Surgical Procedure Packs cleared by the FDA?

Surgical Procedure Packs (K110724) received a 510(k) decision of Substantially Equivalent on June 23, 2011, 99 days after the submission was received.

What is the product code of K110724?

The FDA product code is FYA – Gown, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.4040.