510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K153409Substantially Equivalent

Protect U Guard Earloop and Tie-On Mask (Blue, White or Green)

Protect U Guard, LLC, Safety Harbor FL / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K153409 is the FDA 510(k) clearance record for Protect U Guard Earloop and Tie-On Mask (Blue, White or Green), a class II device, cleared for Protect U Guard, LLC on under FDA product code FXX (Mask, Surgical). FDA records list one 510(k) clearance for Protect U Guard, LLC. As of , FDA records show no recalls naming K153409.

Clearance record

Decision date
Received
(356 days to decision)
Product code
FXX Mask, Surgical
Regulation
21 CFR 878.4040
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Protect U Guard, LLC 1840 Mease Dr., Safety Harbor FL
510(k) summary
Summary PDF
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