510(k) Report

510(k) · Cleared

Cleared

Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs-Violet Blue (VBLU)

K151997510(k) TraditionalCleared Mar 31, 2016255-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

Hartalega NGC Sdn. Bhd. · LZA Polymer Patient Examination Glove

Cleared on Mar 31, 2016 after a 255-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.

Decided
Mar 31, 2016
Review
255 days
Class
Class I
Product code
LZA
Recalls
None
Predicates
0

3 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2022: 1 descendant cleared2016: 1 descendant cleared2025: 1 descendant cleared201620182020202220242026
  1. This deviceK151997 Nitrile Powder Free Examination Gloves Tested for Use with…Hartalega NGC Sdn. Bhd. · 2016
  2. Descendant · cites it directly · 1 of its ownK222225 Nitrile Powder Free Examination Glove Tested for Use with…Hartalega NGC Sdn. Bhd. · 2022
  3. Descendant · 2 generations on · 0 of its ownK243818 Nitrile Powder Free Examination Glove Tested for Use with…Hartalega NGC Sdn. Bhd. · 2025
  4. Descendant · cites it directly · 0 of its ownK162095 Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use…Yty Industry (Manjung) Sdn Bhd · 2016

Most influential descendants

Showing 3 of 3 · See all
  • K222225Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue)Hartalega NGC Sdn. Bhd. · 2022 · cites it directly1descendant
  • K243818Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and…Hartalega NGC Sdn. Bhd. · 2025 · 2 generations on0descendants
  • K162095Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy…Yty Industry (Manjung) Sdn Bhd · 2016 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K151997Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy…Hartalega NGC Sdn. Bhd.2016—
+1K222225Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs…Hartalega NGC Sdn. Bhd.2022—
+2K243818Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs…Hartalega NGC Sdn. Bhd.2025—
+1K162095Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with…Yty Industry (Manjung) Sdn Bhd2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201610
202210
202510
FIG. 1 — Lineage of K151997, 2016–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (3)

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

NumberDeviceApplicantDecidedDescendants
K222225Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue)Hartalega NGC Sdn. Bhd.20221
K162095Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy…Yty Industry (Manjung) Sdn Bhd20160

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, K222225 (Hartalega NGC Sdn. Bhd., 2022) has gone furthest, with 1 descendant 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. 2016, 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 Examination Glove Tested for Use with Chemotherapy Drugs - Violet Blue (VBLU) is nonsterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs. The list of Chemotherapy Drugs tested (with breakthrough times) is as below: Carmustine (3.3 mg/ml) 10.2 minutes Cisplatin (1.0 mg/ml) >240 minutes…

Read the full statement (140 words)

The Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs - Violet Blue (VBLU) is nonsterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs.

The list of Chemotherapy Drugs tested (with breakthrough times) is as below:

Carmustine (3.3 mg/ml) 10.2 minutes

Cisplatin (1.0 mg/ml) >240 minutes

Cyclophosphamide (20 mg/ml) >240 minutes

Dacarbazine (10.0 mglml) >240 minutes

Doxorubicin Hydrochloride (2.0 mg/ml) >240 minutes

Etoposide (20.0 mg/ml) >240 minutes

Fluorouracil (50.0 mg/ml) >240 minutes

Methotrexate (25 mg/ml) >240 minutes

Mitomycin C (0.5 mg/ml) >240 minutes

Paclitaxel (6.0 mg/ml) >240 minutes

Thiotepa (10.0 mg/ml) 30.2 minutes

Vincristine Sulfate (1.0 mg/ml) >240 minutes

Please note that Carmustine and Thiotepa have extremely low permeation times of 10.2 minutes and 30.2 minutes.

Indications for use as stated in the FDA 510(k) statement.

More from Hartalega NGC Sdn. Bhd.

31 FDA decisions under this applicant name. See the company

  • K260558Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Latex Powder…Hartalega NGC Sdn. Bhd. · 2026
  • K254285Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Aqua Blue; Nitrile Powder…Hartalega NGC Sdn. Bhd. · 2026
  • K260867Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)…Hartalega NGC Sdn. Bhd. · 2026
  • K250861Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated…Hartalega NGC Sdn. Bhd. · 2025
  • K251319Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate…Hartalega NGC Sdn. Bhd. · 2025

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/K151997 · printed Nov 3, 2026

Cite this page

510(k) Report. “K151997: Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs-Violet Blue (VBLU).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K151997

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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