Sri PLR Gown

FDA 510(k) K080707 · Sri/Surgical Express

Substantially Equivalent

510(k) numberK080707

Submission

Device name
Sri PLR Gown
Applicant
Sri/Surgical Express
Austin, TX, US
Received
March 12, 2008
Decision date
November 13, 2008
Decision
Substantially Equivalent (SESE)
Type
Abbreviated 510(k)
Summary
510(k) statement 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

Other 510(k)s with product code FYA

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K260407Principle & Will ANSI/AAMI PB 70 (Sterile/Non-sterile) Level 3 Surgical Gowns…FYA · Traditional Principle & Will Co., Ltd.08/26/2026SE
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.

510(k)DeviceDecision
K080796Sri LP DrapeKKX · Abbreviated 11/17/2008SE
K080723Sri LP GownFYA · Abbreviated 11/13/2008SE
K023635Sri/Surgical Express SP Reusable Surgical GownFYA · Traditional 11/18/2002SE

Questions and answers

When was Sri PLR Gown cleared by the FDA?

Sri PLR Gown (K080707) received a 510(k) decision of Substantially Equivalent on November 13, 2008, 246 days after the submission was received.

What is the product code of K080707?

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