510(k) Report

510(k) · Cleared

Cleared

Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties))

K173062510(k) TraditionalCleared Jan 25, 2018119-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

V&Q Manufacturing Corporation · FXX Mask, Surgical

Cleared on Jan 25, 2018 as substantially equivalent to K122717 (Tiger Medical Products, Ltd., 2012) after a 119-day review. Its family tree reaches back 5 generations to 1997. 35 later devices descend from it.

Decided
Jan 25, 2018
Review
119 days
Class
Class II
Product code
FXX
Recalls
None
Predicates
1

Its longest line of descent runs back 5 generations to K970835 (1997). 35 later devices descend from it, 8 citing it directly.

Descendants, by year cleared 2021: 24 descendants cleared2020: 2 descendants cleared2022: 6 descendants cleared2024: 2 descendants cleared2026: 1 descendant clearedK970835 · Face Mask, Surgical Mask, Non-Sterile · Tucker & Associates · 1997K022256 · Surgical Face Mask - Colors: White, Yellow, Pink, Blue, and Green · Tucker & Associates · 2004×2: 2 generations cleared close together, K060776 (2006), K061716 (2006) K122717 · Face Mask, Surgical Mask, Procedure Mask, Surgical Face Mask · Tiger Medical Products, Ltd. · 20121995200020052010201520202025
Descendants, by generation 1 generation forward: 8 descendants2 generations forward: 22 descendants3 generations forward: 4 descendants4 generations forward: 1 descendant K122717 · Face Mask, Surgical Mask, Procedure Mask, Surgical Face Mask · Tiger Medical Products, Ltd. · 2012K061716 · Prestige Ameritech Face Mask · Prestige Ameritech · 2006K060776 · Surgical Face Mask · Hong YA Non-Woven Products Co., Ltd. · 2006K022256 · Surgical Face Mask - Colors: White, Yellow, Pink, Blue, and Green · Tucker & Associates · 2004K970835 · Face Mask, Surgical Mask, Non-Sterile · Tucker & Associates · 1997−50
  1. Root · 5 generations backK970835 Face Mask, Surgical Mask, Non-SterileTucker & Associates · 1997
  2. 4 generations backK022256 Surgical Face Mask - Colors: White, Yellow, Pink, Blue, and GreenTucker & Associates · 2004
  3. 3 generations backK060776 Surgical Face MaskHong YA Non-Woven Products Co., Ltd. · 2006
  4. 2 generations backK061716 Prestige Ameritech Face MaskPrestige Ameritech · 2006
  5. 1 generation backK122717 Face Mask, Surgical Mask, Procedure Mask, Surgical Face MaskTiger Medical Products, Ltd. · 2012
  6. This deviceK173062 Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties))V&Q Manufacturing Corporation · 2018
  7. Descendant · cites it directly · 17 of its ownK201479 DemeMASKDemetech Corporation · 2020
  8. Descendant · cites it directly · 5 of its ownK202843 Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile)B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. · 2021
  9. Descendant · 2 generations on · 4 of its ownK210030 Medical Surgical MaskTianjin Aoshang Outdoor Equipment Co., Ltd. · 2021
  10. Descendant · cites it directly · 2 of its ownK202719 Disposable Medical Face MasksJiangxi Sanxin Medtec Co., Ltd. · 2021
  11. Descendant · cites it directly · 2 of its ownK202029 Medical Surgical MaskBeijing Biosis Healing Biolog Ical Technology Co., Ltd. · 2020

Showing 5 of 35 descendants. See all descendants

Descendants cleared per year

2020: 22021: 242022: 62024: 22026: 1
2020high 24 (2021) · low 0 (2023)2026

Most influential descendants

Showing 5 of 35 · See all
  • K201479DemeMASKDemetech Corporation · 2020 · cites it directly17descendants
  • K202843Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile)B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. · 2021 · cites it directly5descendants
  • K210030Medical Surgical MaskTianjin Aoshang Outdoor Equipment Co., Ltd. · 2021 · 2 generations on4descendants
  • K202719Disposable Medical Face MasksJiangxi Sanxin Medtec Co., Ltd. · 2021 · cites it directly2descendants
  • K202029Medical Surgical MaskBeijing Biosis Healing Biolog Ical Technology Co., Ltd. · 2020 · cites it directly2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K970835Face Mask, Surgical Mask, Non-SterileTucker & Associates1997—
−4K022256Surgical Face Mask - Colors: White, Yellow, Pink, Blue, and GreenTucker & Associates2004—
−3K060776Surgical Face MaskHong YA Non-Woven Products Co., Ltd.2006—
−2K061716Prestige Ameritech Face MaskPrestige Ameritech2006—
−1K122717Face Mask, Surgical Mask, Procedure Mask, Surgical Face MaskTiger Medical Products, Ltd.2012—
0 (this device)K173062Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties))V&Q Manufacturing Corporation2018—
+1K201479DemeMASKDemetech Corporation2020—
+1K202843Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile)B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.2021—
+2K210030Medical Surgical MaskTianjin Aoshang Outdoor Equipment Co., Ltd.2021—
+1K202719Disposable Medical Face MasksJiangxi Sanxin Medtec Co., Ltd.2021—
+1K202029Medical Surgical MaskBeijing Biosis Healing Biolog Ical Technology Co., Ltd.2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202020
2021240
202260
202420
202610
FIG. 1 — Lineage of K173062, 1997–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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

TypeNumberDeviceApplicantDecidedRecalls
*K122717Face Mask, Surgical Mask, Procedure Mask, Surgical Face Mask
Summary page 4
…I (3) Predicate device Sponsor Tiger Medical Products Ltd. Device Name Face Mask, Surgical Mask, Surgical Face Mask 510(k) Number K122717 Product Code FXX Regulation Number 21 CFR 878.4040 Regulation Class II (4) Description/ Design of devic…
Tiger Medical Products, Ltd.2012—

Also cleared against K122717: 2 other devices →

What descends from it? (35)

See all 35

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

NumberDeviceApplicantDecidedDescendants
K201479DemeMASKDemetech Corporation202017
K202843Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile)B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.20215
K202719Disposable Medical Face MasksJiangxi Sanxin Medtec Co., Ltd.20212
K202029Medical Surgical MaskBeijing Biosis Healing Biolog Ical Technology Co., Ltd.20202
K202904Surgical Face MaskJiangxi Feilikang Medical Technology Co., Ltd.20211
K211487MAF GuardMaf Clothing Pvt Ltd Unit-320210
K203704Surgical face maskJuntech (Jiaxing)Healthcare Materials Co,.Ltd20210
K202628Disposable Medical Face MaskQinghai Zhong Dao Win-Win Medical Protective Equipment Co.,20210

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 21 years and passes through 5 companies; a new generation was cleared every 5.1 years on median.
  • None of the 5 ancestors has a recall.
  • Of its descendants, K201479 (Demetech Corporation, 2020) has gone furthest, with 17 descendants of its own.
  • 2 other devices also cite its predicate K122717.

How does its category compare?

All FXX devices

FXX Mask, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.

FDA decisions per year · FXX

6in 2025

2007: 22008: 22009: 12010: 72011: 62012: 12013: 32014: 12015: 52016: 52017: 12018: 32019: 42020: 272021: 2182022: 912023: 222024: 152025: 62026 (partial year): 5
2007high 218 (2021) · low 1 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FXX

123in 2025

2010: 144 days median2011: 137 days median2013: 219 days median2015: 298 days median2016: 268 days median2018: 119 days median2019: 124 days median2020: 113 days median2021: 162 days median2022: 113 days median2023: 139 days median2024: 263 days median2025: 123 days median2026 (partial year): 142 days median
2007high 298 (2015) · low 113 (2020)2026

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

Recalls per year · FXX

2in 2024

2019: 22023: 12024: 2
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

2007: 112008: 102009: 32010: 92011: 82012: 222013: 92014: 52015: 142016: 162017: 452018: 212019: 232020: 602021: 672022: 212023: 212024: 212025: 11
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—011
20082—010
20091—03
2010714409
2011613708
20121—022
2013321909
20141—05
20155298014
20165268016
20171—045
20183119021
20194124223
202027113060
2021218162067
202291113021
202322139121
202415263221
20256123011
202651420—

What is it indicated for?

Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties)) is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.

Indications for use as stated in the FDA summary.

Also cleared against K122717

2 other devices cite the same predicate.

  • K210256CiRx (R) Surgical MaskNingbo Shun YE Medical Company, Ltd. · 2021
  • K153409Protect U Guard Earloop and Tie-On Mask (Blue, White or Green)Protect U Guard, LLC · 2016

Recent decisions in FXX

The FXX category page

  • K251967HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD*…O&M Halyard, Inc. · 2026
  • K252534Surgical Face Mask (Ear mount)Zhejiang Hangkang Medical Equipment Co., Ltd. · 2026
  • K253398Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)Efofex, Inc. · 2026
  • K252830Disposable Surgical Face Mask (3P00B, C2900)Beatles Medical Supplies (Xiantao) Co., Ltd. · 2026
  • K252650Disposable Medical Face MaskMakrite Industries, Inc. · 2026

https://510kreport.com/device/K173062 · printed Nov 6, 2026

Cite this page

510(k) Report. “K173062: Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties)).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173062

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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