510(k) · Cleared
ClearedBlue, Latex Powder Free Examination Gloves, Tested for Use with Chemotherapy Drugs with Protein Labling Claim (50UG/DM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Northstar Healthcare Holdings · LZC Medical Glove, Specialty
Cleared on Sep 20, 2012 as substantially equivalent to K083409 (Wrp Asia Pacific Sdn. Bhd., 2009) after an 80-day review. Its family tree reaches back 2 generations to 1999. 1 later device descends from it.
- Decided
- Sep 20, 2012
- Review
- 80 days
- Class
- Class I
- Product code
- LZC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K972615 (1999). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK972615 Chemo Plus Powder Free Blue Latex Examination Gloves (Protein…Wembley Rubber Products (M) Sdn Bhd · 1999 · Recalled
- 1 generation backK083409 Powder Free Blue Latex Patient Examination Gloves, Tested for Use…Wrp Asia Pacific Sdn. Bhd. · 2009
- This deviceK121926 Blue, Latex Powder Free Examination Gloves, Tested for Use with…Northstar Healthcare Holdings · 2012
- Descendant · cites it directly · 0 of its ownK221157 JR MedicJr Engineering & Medical Technologies (M) Sdn. Bhd. · 2022
Most influential descendants
Showing 1 of 1 · See all- K221157JR MedicJr Engineering & Medical Technologies (M) Sdn. Bhd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K972615 | Chemo Plus Powder Free Blue Latex Examination Gloves (Protein Content Labeling) | Wembley Rubber Products (M) Sdn Bhd | 1999 | 3 |
| −1 | K083409 | Powder Free Blue Latex Patient Examination Gloves, Tested for Use with… | Wrp Asia Pacific Sdn. Bhd. | 2009 | — |
| 0 (this device) | K121926 | Blue, Latex Powder Free Examination Gloves, Tested for Use with Chemotherapy… | Northstar Healthcare Holdings | 2012 | — |
| +1 | K221157 | JR Medic | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
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 LZC? 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 LZC device
- #1 K201390 Medline Powder-Free Light Blue Nitrile Exam…score 19.2 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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 | Decided |
|---|---|---|---|
| * | K083409 | Powder Free Blue Latex Patient Examination Gloves, Tested for Use with Chemotherapy…Summary page 1…e Indication Clearance Company 510(k) Date K083409 Latex Powder Free The latex examination glove (Tested for 29 Jul 2009 WRP ASIA Examination Gloves… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221157 | JR Medic | 2022 | 0 |
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 13 years and passes through 3 companies; a new generation was cleared every 10.5 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K221157 (Jr Engineering & Medical Technologies (M) Sdn. Bhd., 2022) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K083409.
How does its category compare?
All LZC devicesLZC Medical Glove, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · LZC
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LZC
85in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZC
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZC
10in 2025
MAUDE reports naming product code LZC, 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 | 1 | — | 0 | 0 |
| 2008 | 3 | 166 | 1 | 0 |
| 2009 | 5 | 253 | 0 | 1 |
| 2010 | 5 | 68 | 0 | 0 |
| 2011 | 0 | — | 4 | 1 |
| 2012 | 4 | 149 | 0 | 1 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 3 | 258 | 0 | 5 |
| 2017 | 6 | 121 | 0 | 7 |
| 2018 | 6 | 105 | 0 | 6 |
| 2019 | 7 | 200 | 0 | 8 |
| 2020 | 3 | 167 | 0 | 1 |
| 2021 | 3 | 94 | 1 | 2 |
| 2022 | 7 | 85 | 0 | 2 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 16 |
| 2025 | 1 | — | 0 | 10 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The examination glove 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. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation of Chemotherapy Drugs: Chemotherapy Drug and Concentration Minimum Breakthrough Detection Time in Minutes…
Read the full statement (146 words)
The examination glove 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.
In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation of Chemotherapy Drugs:
Chemotherapy Drug and Concentration Minimum Breakthrough Detection Time in Minutes
Carmustine (BCNU)(3.3 mg/mL) 15.4
Cisplatin (1.0 mg/mL) >240
Cyclophosphamide (Cytoxan) (20.0 mg/mL) >240
Dacarbazine (DTIC) (10.0 mg/mL) >240
Doxorubicin Hydrochloride (2.0 mg/mL) >240
Etoposide (20.0 mg/mL) >240
Fluorouracil (Adrucil) (50.0 mg/mL) >240
Methotrexate (25 mg/mL) >240
Mitomycin C (0.5mg/mL) >240
Paclitaxel (taxol) (6.0 mg/mL) >240
Thiotepa (10.0 mg/mL) 1.6
Vincristine Sulfate (1.0 mg/mL) >240
The maximum testing time is 240 minutes- Please note that the following drugs, Carmustine (BCNUJ) and Thiotepa have extremely low permeation time of less than 30 minutes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121926 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121926: Blue, Latex Powder Free Examination Gloves, Tested for Use with Chemotherapy Drugs with Protein Labling Claim (50UG/DM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121926
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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