510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K230380Substantially Equivalent

Surgical Face Masks, Model: EFMDS-L50Pn BLU

Iris USA Inc, Pleasant Prairie WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K230380 is the FDA 510(k) clearance record for Surgical Face Masks, Model: EFMDS-L50Pn BLU, a class II device, cleared for Iris USA on under FDA product code FXX (Mask, Surgical). FDA records list one 510(k) clearance for Iris USA. As of , FDA records show no recalls naming K230380.

Clearance record

Decision date
Received
(171 days to decision)
Product code
FXX Mask, Surgical
Regulation
21 CFR 878.4040
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Iris USA 11111 80th Ave., Pleasant Prairie WI
510(k) summary
Statement
Third party review
No

Clearances, product code FXX

Trailing 12 months
8 clearances under product code FXX in the twelve months to October 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code FXX, trailing twelve months
MonthClearances
November 20251
December 20252
January 20262
February 20261
March 20262
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260