510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K905803Substantially Equivalent

Hale Sun Surgical Towel or o.r. Towel

Hale Sun Industries, Ltd., Providence RI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K905803 is the FDA 510(k) clearance record for HALE SUN SURGICAL TOWEL OR O.R. TOWEL, a class II device, cleared for Hale Sun Industries, Ltd. on under FDA product code KKX (Drape, Surgical, Antimicrobial). FDA's definition for product code KKX reads: "Surgical drapes with an antimicrobial agent are subject to 510(k) review, under the procedures established by the 21st Century Cures Act. This product code is the class II non-exempt counterpart of PUI". FDA records list one 510(k) clearance for Hale Sun Industries, Ltd. As of , FDA records show no recalls naming K905803.

Clearance record

Decision date
Received
(144 days to decision)
Product code
KKX Drape, Surgical, Antimicrobial
Regulation
21 CFR 878.4370
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Hale Sun Industries, Ltd. One Richmond Squar, Providence RI
Third party review
No

Clearances, product code KKX

Trailing 12 months

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

FDA records show no clearances under product code KKX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KKX, 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