510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K252575Substantially Equivalent

Tuff Cuff™ Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)

New York Embroidery Studio (NYES), New York NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K252575 is the FDA 510(k) clearance record for Tuff Cuff™ Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L), a class II device, cleared for New York Embroidery Studio (NYES) on under FDA product code FYA (Gown, Surgical). FDA records list one 510(k) clearance for New York Embroidery Studio (NYES). As of , FDA records show no recalls naming K252575.

Clearance record

Decision date
Received
(294 days to decision)
Product code
FYA Gown, Surgical
Regulation
21 CFR 878.4040
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
New York Embroidery Studio (NYES) 140 W 58th St., Bldg. A, Suite 8n, New York NY
510(k) summary
Statement
Third party review
No

Clearances, product code FYA

Trailing 12 months
10 clearances under product code FYA in the twelve months to October 2026, February 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code FYA, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20262
March 20260
April 20262
May 20261
June 20261
July 20261
August 20262
September 20260
October 20260