510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K880385Substantially Equivalent

Kimberly-Clark Professional Jacket

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

K880385 is the FDA 510(k) clearance record for KIMBERLY-CLARK PROFESSIONAL JACKET, a class I device, cleared for Kimberly-Clark Corp. on under FDA product code FME (Gown, Examination). FDA records list 122 510(k) clearances for Kimberly-Clark Corp., from to . As of , FDA records show no recalls naming K880385.

Clearance record

Decision date
Received
(22 days to decision)
Product code
FME Gown, Examination
Regulation
21 CFR 880.6265
Device class
Class I
Review panel
General Hospital
Applicant
Kimberly-Clark Corp. 1400 Holcomb Bridge Rd., Roswell GA
Third party review
No

Clearances, product code FME

Trailing 12 months

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

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