510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K023969Substantially Equivalent

Reactive Skin Decontamination Lotion

Dept. of the Army, Fort Detrick MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K023969 is the FDA 510(k) clearance record for REACTIVE SKIN DECONTAMINATION LOTION, a class I device, cleared for Dept. of the Army on under FDA product code MAC (Decontamination Kit). FDA's definition for product code MAC reads: "This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at...". FDA records list 5 510(k) clearances for Dept. of the Army, from to . As of , FDA records show one recall naming K023969.

Clearance record

Decision date
Received
(116 days to decision)
Product code
MAC Decontamination Kit
Regulation
21 CFR 878.4014
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Dept. of the Army Chemical-Biological Mgt.Office, Fort Detrick MD
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MAC

Trailing 12 months

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

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