510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K910410Substantially Equivalent

Surgical Gowns, Extra-Large Size

Dawn of Hope Development Center, Johnson City TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K910410 is the FDA 510(k) clearance record for SURGICAL GOWNS, EXTRA-LARGE SIZE, a class II device, cleared for Dawn of Hope Development Center on under FDA product code FYC (Gown, Isolation, Surgical). FDA records list one 510(k) clearance for Dawn of Hope Development Center. As of , FDA records show no recalls naming K910410.

Clearance record

Decision date
Received
(86 days to decision)
Product code
FYC Gown, Isolation, Surgical
Regulation
21 CFR 878.4040
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Dawn of Hope Development Center 1500 E. Millard St., Johnson City TN
Third party review
No

Clearances, product code FYC

Trailing 12 months

FDA records hold no clearances under product code FYC in the trailing twelve months.

FDA records show no clearances under product code FYC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FYC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260