510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K171162Substantially Equivalent

Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap Shield

Prestige Ameritech, North Richland Hills TX / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)

K171162 is the FDA 510(k) clearance record for Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap Shield, a class II device, cleared for Prestige Ameritech on under FDA product code FXX (Mask, Surgical). FDA records list 6 510(k) clearances for Prestige Ameritech, from to . As of , FDA records show no recalls naming K171162.

Clearance record

Decision date
Received
(117 days to decision)
Product code
FXX Mask, Surgical
Regulation
21 CFR 878.4040
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Prestige Ameritech 7201 Iron Horse Blvd., North Richland Hills TX
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