FDA 510(k) clearance · back to tracker

NYES Tuff Cuff L3 Disposable Gowns

New York Embroidery Studio cleared K261949 on 2026-07-10, decision: substantially equivalent

K-number

K261949

Sponsor

New York Embroidery Studio

Device

NYES Tuff Cuff L3 Disposable Gowns

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-07-10

Product code

FYA

Advisory committee

General, Plastic Surgery

Medical specialty

General, Plastic Surgery

Regulation number

878.4040

Official FDA record

Open K261949on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.