510(k) Report

510(k) · Cleared

Cleared

Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color

K171422510(k) AbbreviatedCleared Jun 11, 2018392-day reviewClass I21 CFR 880.6250

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

Ever Global (Vietnam) Enterprise Corp · LZA Polymer Patient Examination Glove

Cleared on Jun 11, 2018 after a 392-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 60 later devices descend from it.

Decided
Jun 11, 2018
Review
392 days
Class
Class I
Product code
LZA
Recalls
None
Predicates
0

60 later devices descend from it, 45 citing it directly.

Descendants, by year cleared 2021: 36 descendants cleared2018: 2 descendants cleared2022: 13 descendants cleared2023: 5 descendants cleared2024: 2 descendants cleared2026: 2 descendants cleared201620182020202220242026
  1. This deviceK171422 Disposable Powder Free Nitrile Examination Glove, White/ Blue/…Ever Global (Vietnam) Enterprise Corp · 2018
  2. Descendant · cites it directly · 4 of its ownK213121 Disposable Nitrile Examination GloveJiangsu Cureguard Glove Co., Ltd. · 2022
  3. Descendant · 2 generations on · 3 of its ownK232008 Disposable Medical Examination Nitrile GlovesRaxwell Industrial, LLC · 2023
  4. Descendant · cites it directly · 2 of its ownK211914 Nitrile Patient Examination GlovesYingxiang Glove Products Co., Ltd. · 2021
  5. Descendant · cites it directly · 2 of its ownK210276 Disposable Nitrile GlovesFujian Ercon Medical Management Co., Ltd. · 2021
  6. Descendant · cites it directly · 2 of its ownK210057 Blue Nitrile Exam Glove, Powder FreeReal Star Medical Technology Co., Ltd. · 2021

Showing 5 of 60 descendants. See all descendants

Descendants cleared per year

2018: 22021: 362022: 132023: 52024: 22026: 2
2018high 36 (2021) · low 0 (2019)2026

Most influential descendants

Showing 5 of 60 · See all
  • K213121Disposable Nitrile Examination GloveJiangsu Cureguard Glove Co., Ltd. · 2022 · cites it directly4descendants
  • K232008Disposable Medical Examination Nitrile GlovesRaxwell Industrial, LLC · 2023 · 2 generations on3descendants
  • K211914Nitrile Patient Examination GlovesYingxiang Glove Products Co., Ltd. · 2021 · cites it directly2descendants
  • K210276Disposable Nitrile GlovesFujian Ercon Medical Management Co., Ltd. · 2021 · cites it directly2descendants
  • K210057Blue Nitrile Exam Glove, Powder FreeReal Star Medical Technology Co., Ltd. · 2021 · cites it directly2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K171422Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink ColorEver Global (Vietnam) Enterprise Corp2018—
+1K213121Disposable Nitrile Examination GloveJiangsu Cureguard Glove Co., Ltd.2022—
+2K232008Disposable Medical Examination Nitrile GlovesRaxwell Industrial, LLC2023—
+1K211914Nitrile Patient Examination GlovesYingxiang Glove Products Co., Ltd.2021—
+1K210276Disposable Nitrile GlovesFujian Ercon Medical Management Co., Ltd.2021—
+1K210057Blue Nitrile Exam Glove, Powder FreeReal Star Medical Technology Co., Ltd.2021—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201820
2021360
2022130
202350
202420
202620
FIG. 1 — Lineage of K171422, 2018–2026Source: 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 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LZA? 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 LZA device

  1. #1 K192333 Blue Nitrile Examination Gloves Powder Freescore 71.0 · 2 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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (60)

See all 60

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

NumberDeviceApplicantDecidedDescendants
K213121Disposable Nitrile Examination GloveJiangsu Cureguard Glove Co., Ltd.20224
K211914Nitrile Patient Examination GlovesYingxiang Glove Products Co., Ltd.20212
K210276Disposable Nitrile GlovesFujian Ercon Medical Management Co., Ltd.20212
K210057Blue Nitrile Exam Glove, Powder FreeReal Star Medical Technology Co., Ltd.20212
K183068Nitrile Glove Powder Free WhiteHaining Medical Products Co., Ltd.20182
K222498Medical Examination Gloves (Nitrile) (XS, S, M, L, XL)Humanwell Healthcare Group Medical Supplies Co., Ltd.20221
K220343Nitrile Examination GlovesNb Medical Co., Ltd.20221
K211341Blue Nitrile Exam GlovesJiangxi Surefine Medical Co., Ltd.20211
K230777Patient Examination Gloves3A Glove Sdn. Bhd.20230
K230542Disposable Nitrile Gloves (ABC-DG01)Huizhou Anboson Technology Co., Ltd.20230

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?

  • Of its descendants, K213121 (Jiangsu Cureguard Glove Co., Ltd., 2022) has gone furthest, with 4 descendants of its own.

How does its category compare?

All LZA devices

LZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.

FDA decisions per year · LZA

24in 2025

2007: 212008: 182009: 282010: 312011: 262012: 332013: 202014: 272015: 202016: 302017: 442018: 222019: 252020: 302021: 1392022: 1462023: 622024: 302025: 242026 (partial year): 15
2007high 146 (2022) · low 18 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LZA

110in 2025

2007: 95 days median2008: 97 days median2009: 112 days median2010: 97 days median2011: 122 days median2012: 110 days median2013: 130 days median2014: 197 days median2015: 112 days median2016: 171 days median2017: 124 days median2018: 178 days median2019: 212 days median2020: 101 days median2021: 111 days median2022: 111 days median2023: 92 days median2024: 89 days median2025: 110 days median2026 (partial year): 103 days median
2007high 212 (2019) · low 89 (2024)2026

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

Recalls per year · LZA

3so far in 2026, the most since 2007

2015: 12016: 12026 (partial year): 3
2007high 3 (2026) · low 0 (2007)2026

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

Adverse event reports per year · LZA

73in 2025

2007: 72008: 22009: 122010: 122011: 92012: 112013: 102014: 82015: 122016: 252017: 42018: 32019: 212020: 42021: 202022: 192023: 242024: 762025: 73
2007high 76 (2024) · low 2 (2008)2025

MAUDE reports naming product code LZA, 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
2007219507
2008189702
200928112012
20103197012
20112612209
201233110011
201320130010
20142719708
201520112112
201630171125
20174412404
20182217803
201925212021
20203010104
2021139111020
2022146111019
20236292024
20243089076
202524110073
2026151033—

What is it indicated for?

The Nitrile Powder Free patient examination glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

More from Ever Global (Vietnam) Enterprise Corp

3 FDA decisions under this applicant name. See the company

  • K193555Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and…Ever Global (Vietnam) Enterprise Corp · 2020
  • K170575Disposable Powder Free Vinyl Exam Glove, Clear/YellowEver Global (Vietnam) Enterprise Corp · 2017

Recent decisions in LZA

The LZA category page

  • K262208Non-sterile, Powder Free Nitrile Examination Aloe Vera Green Gloves, Low Dermatitis Potential, Tested for…Yty Industry (Manjung) Sdn Bhd · 2026
  • K261793Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and…Maxter Healthcare, Inc. · 2026
  • K262542Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder Free Examination…Top Glove Sdn. Bhd. · 2026
  • K260312Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl…Gmp Medicare Sdn. Bhd. · 2026
  • K261749Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl CitrateCardinalhealth · 2026

https://510kreport.com/device/K171422 · printed Nov 6, 2026

Cite this page

510(k) Report. “K171422: Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171422

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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