510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K863359Substantially Equivalent

Bouffant-Style Surgical Cap

Kimberly-Clark Corporation, Roswell GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K863359 is the FDA 510(k) clearance record for BOUFFANT-STYLE SURGICAL CAP, a class I device, cleared for Kimberly-Clark Corp. on under FDA product code FYF (Cap, Surgical). FDA records list 122 510(k) clearances for Kimberly-Clark Corp., from to . As of , FDA records show no recalls naming K863359.

Clearance record

Decision date
Received
(27 days to decision)
Product code
FYF Cap, Surgical
Regulation
21 CFR 878.4040
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Kimberly-Clark Corp. 1400 Holcomb Bridge Rd., Roswell GA
Third party review
No

Clearances, product code FYF

Trailing 12 months

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

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