510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K781019Substantially Equivalent

Surg. Gown & Drape, Low Lint Treatment

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

K781019 is the FDA 510(k) clearance record for SURG. GOWN & DRAPE, LOW LINT TREATMENT, a class II device, cleared for Kimberly-Clark Corp. on under FDA product code KKY (Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction). FDA records list 122 510(k) clearances for Kimberly-Clark Corp., from to . As of , FDA records show no recalls naming K781019.

Clearance record

Decision date
Received
(210 days to decision)
Product code
KKY Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
Regulation
21 CFR 878.3500
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Kimberly-Clark Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KKY

Trailing 12 months

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

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