510(k) · Cleared

Cleared

Surgical Face Mask

K060776510(k) TraditionalCleared May 25, 200664-day reviewClass II21 CFR 878.4040

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Hong YA Non-Woven Products Co., Ltd. · FXX Mask, Surgical

Cleared on May 25, 2006 as substantially equivalent to K022256 (Tucker & Associates, 2004) after a 64-day review. Its family tree reaches back 2 generations to 1997. 73 later devices descend from it.

Decided: May 25, 2006
Review: 64 days
Class: Class II
Product code: FXX
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K970835 (1997). 73 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 2 generations backK970835 Face Mask, Surgical Mask, Non-SterileTucker & Associates · 1997
1 generation backK022256 Surgical Face Mask - Colors: White, Yellow, Pink, Blue, and GreenTucker & Associates · 2004
This deviceK060776 Surgical Face MaskHong YA Non-Woven Products Co., Ltd. · 2006
Descendant · cites it directly · 61 of its ownK061716 Prestige Ameritech Face MaskPrestige Ameritech · 2006
Descendant · 2 generations on · 45 of its ownK122717 Face Mask, Surgical Mask, Procedure Mask, Surgical Face MaskTiger Medical Products, Ltd. · 2012
Descendant · 3 generations on · 35 of its ownK173062 Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties))V&Q Manufacturing Corporation · 2018
Descendant · 4 generations on · 17 of its ownK201479 DemeMASKDemetech Corporation · 2020
Descendant · 3 generations on · 7 of its ownK153409 Protect U Guard Earloop and Tie-On Mask (Blue, White or Green)Protect U Guard, LLC · 2016

Showing 5 of 73 descendants. See all descendants

Descendants cleared per year

2006high 31 (2021) · low 0 (2008)2026

Most influential descendants

Showing 5 of 73 · See all

K061716Prestige Ameritech Face MaskPrestige Ameritech · 2006 · cites it directly61descendants
K122717Face Mask, Surgical Mask, Procedure Mask, Surgical Face MaskTiger Medical Products, Ltd. · 2012 · 2 generations on45descendants
K173062Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties))V&Q Manufacturing Corporation · 2018 · 3 generations on35descendants
K201479DemeMASKDemetech Corporation · 2020 · 4 generations on17descendants
K153409Protect U Guard Earloop and Tie-On Mask (Blue, White or Green)Protect U Guard, LLC · 2016 · 3 generations on7descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K970835	Face Mask, Surgical Mask, Non-Sterile	Tucker & Associates	1997	—
−1	K022256	Surgical Face Mask - Colors: White, Yellow, Pink, Blue, and Green	Tucker & Associates	2004	—
0 (this device)	K060776	Surgical Face Mask	Hong YA Non-Woven Products Co., Ltd.	2006	—
+1	K061716	Prestige Ameritech Face Mask	Prestige Ameritech	2006	—
+2	K122717	Face Mask, Surgical Mask, Procedure Mask, Surgical Face Mask	Tiger Medical Products, Ltd.	2012	—
+3	K173062	Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties))	V&Q Manufacturing Corporation	2018	—
+4	K201479	DemeMASK	Demetech Corporation	2020	—
+3	K153409	Protect U Guard Earloop and Tie-On Mask (Blue, White or Green)	Protect U Guard, LLC	2016	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2007	1	0
2010	1	0
2011	4	0
2012	3	0
2013	3	0
2015	2	0
2016	2	0
2018	1	0
2019	3	0
2020	4	0
2021	31	0
2022	12	0
2023	2	0
2024	2	0
2026	1	0

FIG. 1 — Lineage of K060776, 1997–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FXX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new FXX device

#1 K201479 DemeMASKscore 40.2 · 6 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K022256	Surgical Face Mask - Colors: White, Yellow, Pink, Blue, and Green Summary page 2 …valent in safety and effectiveness to the Tuck & Associates Surgical Face Mask Colors: White, Yellow, Pink, Blue and Green. Test K022256 Hong Ya Surgical Face Mask (Yellow, White,…	Tucker & Associates	2004	—

Also cleared against K022256: 5 other devices →

What descends from it? (73)

See all 73

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K061716	Prestige Ameritech Face Mask	Prestige Ameritech	2006	61
K103150	Kimberly-Clark Child/Pediatric Face Mask	Kimberly-Clark	2011	6
K063043	Surgical Face Mask, Type: Tie-on, Ear-Loop	Modern Healthcare Corp.	2007	5
K101000	Wellmien Surgical Mask	Wellmien (Suzhou) Import & Export Trading Co., Ltd.	2010	4

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 6.6 years on median.
None of the 2 ancestors has a recall.
Of its descendants, K061716 (Prestige Ameritech, 2006) has gone furthest, with 61 descendants of its own.
5 other devices also cite its predicate K022256.

How does its category compare?

All FXX devices

FXX Mask, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FXX

6in 2025

2007high 218 (2021) · low 1 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FXX

123in 2025

2007high 298 (2015) · low 113 (2020)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FXX

2in 2024

2007high 2 (2019) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FXX

11in 2025

2007high 67 (2021) · low 3 (2009)2025

MAUDE reports naming product code FXX, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	2	—	0	11
2008	2	—	0	10
2009	1	—	0	3
2010	7	144	0	9
2011	6	137	0	8
2012	1	—	0	22
2013	3	219	0	9
2014	1	—	0	5
2015	5	298	0	14
2016	5	268	0	16
2017	1	—	0	45
2018	3	119	0	21
2019	4	124	2	23
2020	27	113	0	60
2021	218	162	0	67
2022	91	113	0	21
2023	22	139	1	21
2024	15	263	2	21
2025	6	123	0	11
2026	5	142	0	—

What is it indicated for?

Surgical Face Mask is device that is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operation room personnel from transfer of microorganisms, body fluids and particulate material.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K060776 · printed Nov 4, 2026

Cite this page

510(k) Report. “K060776: Surgical Face Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060776

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026