Product code FYA: 510(k) clearances and predicates
Product code FYA covers Principle & Will ANSI/AAMI PB 70 (Sterile/Non-sterile) Level 3 Surgical Gowns (Reinforced) and Principle & Will ANSI/AMMI PB70 (Sterile/Non-sterile) Level 4 Surgical Gowns/Isolation Gowns. FDA lists 298 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
298 clearances on file under product code FYA. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 24 |
| 2023 | 12 |
| 2024 | 5 |
| 2025 | 4 |
| 2026 so far | 9 |
Recent clearances
Newest FYA clearances in the FDA index, with applicant and decision date:
- K260407, Principle & Will ANSI/AAMI PB 70 (Sterile/Non-sterile) Level 3 Surgical Gowns (Reinforced) and Principle & Will ANSI/AMMI PB70 (Sterile/Non-sterile) Level 4 Surgical Gowns/Isolation Gowns, applicant Principle & Will Co., Ltd., decided 2026-08-26. FDA record
- K261028, Surgical Gown Level2 (S, M, L, XL, XXL, XXXL), applicant Yadu Medical (Henan) Co., Ltd., decided 2026-08-07. FDA record
- K261949, NYES Tuff Cuff L3 Disposable Gowns, applicant New York Embroidery Studio, decided 2026-07-10. FDA record
- K252575, Tuff Cuff Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L), applicant New York Embroidery Studio (NYES), decided 2026-06-04. FDA record
- K260725, BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10), applicant Hindernis DE Mexico, S.A.P.I. DE C.V., decided 2026-05-12. FDA record
- K253243, Cardinal Health Poly Reinforced Surgical Gown, applicant Cardinal Health 200, LLC, decided 2026-04-28. FDA record
- K253003, Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025); Non-sterile Reinforced Level 4 Surgical Gown (G4025); Reinforced Sterile Level 4 Surgical Gown (GM4025), applicant Hubei Xinxin Non-Woven Co., Ltd., decided 2026-04-20. FDA record
- K251860, Copioumed AAMI 3 Surgical Gown, applicant Copioumed International, Inc., decided 2026-02-26. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include Surgical Gown Level2 (S, M, L, XL, XXL, XXXL), NYES Tuff Cuff L3 Disposable Gowns. Watch new FYA clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code FYA?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent FYA clearances include Principle & Will ANSI/AAMI PB 70 (Sterile/Non-sterile) Level 3 Surgical Gowns (Reinforced) and Principle & Will ANSI/AMMI PB70 (Sterile/Non-sterile) Level 4 Surgical Gowns/Isolation Gowns.
How many 510(k) clearances use product code FYA?
298 at the time this page was generated, from openFDA records.
How do I find a predicate device under FYA?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new FYA clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.