510(k) Report

510(k) · Cleared

Cleared

Nitrile Powder Free Patient Examination Gloves, Colored (Blue)

K120970510(k) TraditionalCleared Jul 19, 2012111-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

Tangshan Zhonghong Pulin Plastic Co.,Ltd · LZA Polymer Patient Examination Glove

Cleared on Jul 19, 2012 as substantially equivalent to K993247 (Jda Intl., Inc., 1999) after a 111-day review. Its family tree reaches back 1 generation to 1999. 34 later devices descend from it.

Decided
Jul 19, 2012
Review
111 days
Class
Class I
Product code
LZA
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K993247 (1999). 34 later devices descend from it, 18 citing it directly.

Descendants, by year cleared 2014: 4 descendants cleared2017: 1 descendant cleared2021: 13 descendants cleared2019: 1 descendant cleared2016: 6 descendants cleared2022: 8 descendants cleared2023: 1 descendant clearedK993247 · Nitrile Powder Free Patient Examination Gloves · Jda Intl., Inc. · 19991995200020052010201520202025
Descendants, by generation 1 generation forward: 18 descendants2 generations forward: 4 descendants3 generations forward: 11 descendants4 generations forward: 1 descendant K993247 · Nitrile Powder Free Patient Examination Gloves · Jda Intl., Inc. · 19990
  1. Root · 1 generation backK993247 Nitrile Powder Free Patient Examination GlovesJda Intl., Inc. · 1999
  2. This deviceK120970 Nitrile Powder Free Patient Examination Gloves, Colored (Blue)Tangshan Zhonghong Pulin Plastic Co.,Ltd · 2012
  3. Descendant · cites it directly · 15 of its ownK181106 Powder Free Nitrile Patient Examination Gloves, Blue ColorJiangsu Dongxin Medical Technology Co., Ltd. · 2019
  4. Descendant · 2 generations on · 12 of its ownK203593 Patient Examination GlovesGuangdong Kingfa Sci. & Tech.Co., Ltd. · 2021
  5. Descendant · 3 generations on · 1 of its ownK212924 Nitrile Examination GlovesShanxi Nacosa Medical Technology Co.,Ltd · 2021
  6. Descendant · cites it directly · 1 of its ownK171616 Xingyu Powder Free Nitrile Patient Examination Gloves, Blue colorShandong Xingyu Gloves Co., Ltd. · 2017
  7. Descendant · 4 generations on · 0 of its ownK223280 Disposible Nitrile GlovesHolik Asia Group Co.,Ltd · 2023

Showing 5 of 34 descendants. See all descendants

Descendants cleared per year

2014: 42016: 62017: 12019: 12021: 132022: 82023: 1
2014high 13 (2021) · low 0 (2015)2026

Most influential descendants

Showing 5 of 34 · See all
  • K181106Powder Free Nitrile Patient Examination Gloves, Blue ColorJiangsu Dongxin Medical Technology Co., Ltd. · 2019 · cites it directly15descendants
  • K203593Patient Examination GlovesGuangdong Kingfa Sci. & Tech.Co., Ltd. · 2021 · 2 generations on12descendants
  • K212924Nitrile Examination GlovesShanxi Nacosa Medical Technology Co.,Ltd · 2021 · 3 generations on1descendant
  • K171616Xingyu Powder Free Nitrile Patient Examination Gloves, Blue colorShandong Xingyu Gloves Co., Ltd. · 2017 · cites it directly1descendant
  • K223280Disposible Nitrile GlovesHolik Asia Group Co.,Ltd · 2023 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K993247Nitrile Powder Free Patient Examination GlovesJda Intl., Inc.1999—
0 (this device)K120970Nitrile Powder Free Patient Examination Gloves, Colored (Blue)Tangshan Zhonghong Pulin Plastic Co.,Ltd2012—
+1K181106Powder Free Nitrile Patient Examination Gloves, Blue ColorJiangsu Dongxin Medical Technology Co., Ltd.2019—
+2K203593Patient Examination GlovesGuangdong Kingfa Sci. & Tech.Co., Ltd.2021—
+3K212924Nitrile Examination GlovesShanxi Nacosa Medical Technology Co.,Ltd2021—
+1K171616Xingyu Powder Free Nitrile Patient Examination Gloves, Blue colorShandong Xingyu Gloves Co., Ltd.2017—
+4K223280Disposible Nitrile GlovesHolik Asia Group Co.,Ltd2023—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201440
201660
201710
201910
2021130
202280
202310
FIG. 1 — Lineage of K120970, 1999–2023Source: 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 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? (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
*K993247Nitrile Powder Free Patient Examination Gloves
Summary page 1
…ves, Blue Color that meets all of' the requirements of ASTM standard D 6139- 10 Predicate device : Nitrile powder-free patient examination glove, JDA International Inc. k993247. [(a)(4)] A description ofthedevice Device Description: Powder Free Nitrile Patient Examination Gloves , Blue Color that meets…
Jda Intl., Inc.1999—

Also cleared against K993247: 6 other devices →

What descends from it? (34)

See all 34

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

NumberDeviceApplicantDecidedDescendants
K181106Powder Free Nitrile Patient Examination Gloves, Blue ColorJiangsu Dongxin Medical Technology Co., Ltd.201915
K171616Xingyu Powder Free Nitrile Patient Examination Gloves, Blue colorShandong Xingyu Gloves Co., Ltd.20171
K220211Nitrile Powder Free Examination GlovesHebei Kangxida Medical Technology Development Co., Ltd.20220
K211864Powder Free Nitrile Patient Examination Gloves, Blue ColorSiyang Jaysun Medtech Co., Ltd.20220
K211209Hycare Med+ Nitrile Examination Gloves; Hycare Touch Latex Examination GlovesHycare International Co., Ltd.20210
K210779Powder Free Nitrile Patient Examination Gloves, Blue ColorShandong Shangwei Medical Products Co., Ltd.20210
K210777Powder Free Nitrile Patient Examination Gloves, Blue ColorShandong Jieshi Medical Products Co., Ltd.20210
K211860Powder Free Nitrile Patient Examination Gloves, Blue ColorAnhui Powerguard Technology Co., Ltd.20210
K152707Minghao Nitrile Powder Free Patient Examination Gloves, Blue ColorMinghao Medical Products Co., Ltd.20160
K152705Jiayuan Nitrile Powder Free Patient Examination Gloves, Blue ColorJiayuan Medical Products Co., Ltd.20160

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?

  • Its one ancestor has no recall.
  • Of its descendants, K181106 (Jiangsu Dongxin Medical Technology Co., Ltd., 2019) has gone furthest, with 15 descendants of its own.
  • 6 other devices also cite its predicate K993247.

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. 2012, 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?

Nitrile Powder Free Patient Examination Gloves, Coloured (Blue) is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Indications for use as stated in the FDA summary.

Also cleared against K993247

6 other devices cite the same predicate.

  • K110155Nitrile Powder Free Patient Examination GlovesTangshan Xiangrui Plastic Products Co., Ltd. · 2011
  • K110146Nitrile Powder Free Patient Examination GlovesTangshan Kaiyue Glove Co., Ltd. · 20111 recall
  • K110185Nitrile Powder Free Patient Examination GlovesTangshan Baojie Glove Co., Ltd. · 2011
  • K082598Powder Free Blue Patient Nitrile Examination GloveTangshan Zhonghong Pulin Group Co., Ltd. · 2009
  • K070404Nitrile Powder Free Patient Examination GlovesTangshan Luxiong Plastic Products Co., Ltd. · 2007
  • K030529Legend (Brand) Nitrile Powder-Free Patient Examination GloveJda (Tianjin) Plastic Rubber Co., Ltd. · 2003

More from Tangshan Zhonghong Pulin Plastic Co.,Ltd

2 FDA decisions under this applicant name. See the company

  • K120968Power-Free Vinyl Patient Examination Gloves, Clear (Non-Colored)Tangshan Zhonghong Pulin Plastic Co.,Ltd · 20121 recall

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/K120970 · printed Nov 4, 2026

Cite this page

510(k) Report. “K120970: Nitrile Powder Free Patient Examination Gloves, Colored (Blue).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120970

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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