510(k) · Cleared
ClearedNitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Better Care Plastic Technology Co., Ltd. · LZC Medical Glove, Specialty
Cleared on Aug 27, 2022 as substantially equivalent to K192954 (Comfort Rubber Gloves Industries Sdn. Bhd., 2020) after a 12-day review. Its family tree reaches back 2 generations to 2019.
- Decided
- Aug 27, 2022
- Review
- 12 days
- Class
- Class I
- Product code
- LZC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K183287 (2019). No later device cites it as a predicate yet.
- Root · 2 generations backK183287 Powder Free Nitrile Patient Examination Glove, Blue Colored…Kossan International Sdn Bhd · 2019
- 1 generation backK192954 Power Free Nitrile Examination Gloves Tested for Use with…Comfort Rubber Gloves Industries Sdn. Bhd. · 2020
- This deviceK222449 Nitrile Powder Free Examination Gloves, Tested For Use With…Better Care Plastic Technology Co., Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K183287 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile… | Kossan International Sdn Bhd | 2019 | — |
| −1 | K192954 | Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs… | Comfort Rubber Gloves Industries Sdn. Bhd. | 2020 | — |
| 0 (this device) | K222449 | Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs… | Better Care Plastic Technology Co., Ltd. | 2022 | — |
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 |
|---|---|---|---|
| * | K192954 | Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and FentanylSummary page 4…formation: Comfort Rubber Gloves Industries Sdn. Bhd. Blue Colored, Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K192954) 4. Device Description: Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
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 3 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- None of the 2 ancestors has a recall.
- 10 other devices also cite its predicate K192954.
How does its category compare?
All LZC devicesLZC Medical Glove, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05(2019) Chemotherapy Drug Minimum Breakthrough Detection Time (BDT) in Minutes Carmustine 3.3 mg/ml (3,300 ppm) 11.2 Cisplatin 1mg/ml (1,000 ppm) >240 Cyclophosphamide 20mg/ml (20,000 ppm) >240 Dacarbazine 10…
Read the full statement (138 words)
The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05(2019)
Chemotherapy Drug Minimum Breakthrough Detection Time (BDT) in Minutes
Carmustine 3.3 mg/ml (3,300 ppm) 11.2
Cisplatin 1mg/ml (1,000 ppm) >240
Cyclophosphamide 20mg/ml (20,000 ppm) >240
Dacarbazine 10 mg/ml (10,000 ppm) >240
Doxorubicin HCL, 2 mg/ml (2,000 ppm) >240
Etoposide, 20 mg/ml (20,000 ppm) >240
Fluorouracil, 50mg/ml (50,000ppm) >240
Methotrexate, 25mg/ml (25,000ppm) >240
Paclitaxel, 6mg/ml (6,000ppm) >240
Thiotepa, 10mg/ml (10,000ppm) 294
Fentanyl Citrate Injection (100 mcg/2ml) >240
Fentanyl Citrate Injection (100 mcg/2ml) >240
Please note that the following drugs have extremely low permeation times:
Carmustine: 11.2 minutes, Thio Tepa: 21.6 minutes
*Warning: Do not use with Carmustine and Thio Tepa.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K222449 · printed Nov 5, 2026
Cite this page
510(k) Report. “K222449: Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K222449
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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