FDA 510(k) clearance · back to tracker
Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL)
Yadu Medical (Henan) Co., Ltd. cleared K250564 on 2025-12-03, decision: substantially equivalent
K-number
K250564
Sponsor
Yadu Medical (Henan) Co., Ltd.
Device
Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL)
Class
Class II
Decision
Substantially Equivalent
Decision date
2025-12-03
Product code
FYA
Advisory committee
General, Plastic Surgery
Medical specialty
General, Plastic Surgery
Regulation number
878.4040
Official FDA record
Open K250564on accessdata.fda.gov →
FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.
openFDA JSON
Raw record →
Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.
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Try the sandboxSource
Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.