510(k) · Cleared
ClearedPowder Free Nitrile Examination Gloves (Blue),Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Better Care Plastic Technology Co., Ltd. · LZA Polymer Patient Examination Glove
Cleared on Jul 27, 2022 as substantially equivalent to K192954 (Comfort Rubber Gloves Industries Sdn. Bhd., 2020) after an 86-day review. Its family tree reaches back 2 generations to 2019. 8 later devices descend from it.
- Decided
- Jul 27, 2022
- Review
- 86 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K183287 (2019). 8 later devices descend from it, 4 citing it directly.
- 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 deviceK221269 Powder Free Nitrile Examination Gloves (Blue),Tested for Use with…Better Care Plastic Technology Co., Ltd. · 2022
- Descendant · cites it directly · 3 of its ownK232266 Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non…Better Care Plastic Technology Co., Ltd. · 2023
- Descendant · cites it directly · 1 of its ownK223713 Powder Free Nitrile Examination Glove (Grey) Tested for Use with…Better Care Plastic Technology Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK260703 Powder Free Blue Nitrile Examination Glove - Tested for Use with…S&S Glove Corporation · 2026
- Descendant · 2 generations on · 0 of its ownK242533 Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non…Better Care Plastic Technology Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK243959 Powder Free Nitrile Examination Gloves (Violet, Black, Green)…Lingshi Hongruida Health Protection Technology Co., Ltd. · 2025
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K232266Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Tested for…Better Care Plastic Technology Co., Ltd. · 2023 · cites it directly3descendants
- K223713Powder Free Nitrile Examination Glove (Grey) Tested for Use with Chemotherapy Drugs and…Better Care Plastic Technology Co., Ltd. · 2023 · cites it directly1descendant
- K260703Powder Free Blue Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and…S&S Glove Corporation · 2026 · 2 generations on0descendants
- K242533Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Low…Better Care Plastic Technology Co., Ltd. · 2025 · 2 generations on0descendants
- K243959Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with…Lingshi Hongruida Health Protection Technology Co., Ltd. · 2025 · cites it directly0descendants
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) | K221269 | Powder Free Nitrile Examination Gloves (Blue),Tested for Use with Chemotherapy… | Better Care Plastic Technology Co., Ltd. | 2022 | — |
| +1 | K232266 | Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile… | Better Care Plastic Technology Co., Ltd. | 2023 | — |
| +1 | K223713 | Powder Free Nitrile Examination Glove (Grey) Tested for Use with Chemotherapy… | Better Care Plastic Technology Co., Ltd. | 2023 | — |
| +2 | K260703 | Powder Free Blue Nitrile Examination Glove - Tested for Use with Chemotherapy… | S&S Glove Corporation | 2026 | — |
| +2 | K242533 | Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Low… | Better Care Plastic Technology Co., Ltd. | 2025 | — |
| +1 | K243959 | Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use… | Lingshi Hongruida Health Protection Technology Co., Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 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 K192333 Blue Nitrile Examination Gloves Powder Freescore 71.0 · 2 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 5…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: Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Ci… | 2020 |
What descends from it? (8)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232266 | Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Tested for… | 2023 | 3 |
| K223713 | Powder Free Nitrile Examination Glove (Grey) Tested for Use with Chemotherapy Drugs and… | 2023 | 1 |
| K243959 | Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with… | 2025 | 0 |
| K222181 | Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl Citrate | 2023 | 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 3 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K232266 (Better Care Plastic Technology Co., Ltd., 2023) has gone furthest, with 3 descendants of its own.
- 10 other devices also cite its predicate K192954.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · LZA
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LZA
110in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZA
3so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZA
73in 2025
MAUDE reports naming product code LZA, 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 | 21 | 95 | 0 | 7 |
| 2008 | 18 | 97 | 0 | 2 |
| 2009 | 28 | 112 | 0 | 12 |
| 2010 | 31 | 97 | 0 | 12 |
| 2011 | 26 | 122 | 0 | 9 |
| 2012 | 33 | 110 | 0 | 11 |
| 2013 | 20 | 130 | 0 | 10 |
| 2014 | 27 | 197 | 0 | 8 |
| 2015 | 20 | 112 | 1 | 12 |
| 2016 | 30 | 171 | 1 | 25 |
| 2017 | 44 | 124 | 0 | 4 |
| 2018 | 22 | 178 | 0 | 3 |
| 2019 | 25 | 212 | 0 | 21 |
| 2020 | 30 | 101 | 0 | 4 |
| 2021 | 139 | 111 | 0 | 20 |
| 2022 | 146 | 111 | 0 | 19 |
| 2023 | 62 | 92 | 0 | 24 |
| 2024 | 30 | 89 | 0 | 76 |
| 2025 | 24 | 110 | 0 | 73 |
| 2026 | 15 | 103 | 3 | — |
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 Bleomycin Sulfate 15mg/ml (15000 ppm) >240 Busulfan 6mg/ml (6,000 ppm) >240 Carboplatin 1Omg/ml (10,000 ppm) >240 Carmustine…
Read the full statement (261 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
Bleomycin Sulfate 15mg/ml (15000 ppm) >240
Busulfan 6mg/ml (6,000 ppm) >240
Carboplatin 1Omg/ml (10,000 ppm) >240
Carmustine (BCNU)3.3 mg/ml (3,300 ppm) 11.1
Chloroquine 50mg/ml (50,000ppm) >240
Cisplatin 1mg/ml (1,000 ppm) >240
Cyclophosphamide 20mg/ml (20,000 ppm) >240
Cyclosporin 100 mg/ml (100,000 ppm) >240
Cytarabine HCL, 100 mg/ml (100,000 ppm) >240
Dacarbazine 10 mg/ml (10,000 ppm) >240
Daunorubicin HCL, 5 mg/ml (5,000 ppm) >240
Docetaxel, 10 mg/ml (10,000 ppm) >240
Doxorubicin HCL, 2 mg/ml (2,000 ppm) >240
Epirubicin HCL, 2 mg/ml (2,000 ppm) >240
Etoposide, 20 mg/ml (20,000 ppm) >240
Fludarabine, 25 mg/ml (25,000 ppm) >240
Fluorouracil, 50mg/ml (50,000ppm) >240
Gemcitabine, 38mg/ml (38,000ppm) >240
Idarubicin HCL, lmg/ml (1,000ppm) >240
Ifosfamide, 50mg/ml (50,000ppm) >240
Irinotecan, 20mg/ml (20,000ppm) >240
Mechlorethamine HCI, lmg/ml (1,000ppm) >240
Melphalan, 5mg/ml (5,000ppm) >240
Methotrexate, 25mg/ml (25,000ppm) >240
Mitomycin C, 0.5mg/ml (500ppm) >240
Mitoxantrone HCL, 2mg/ml (2,000ppm) >240
Oxaliplatin, 5mg/ml (5,000ppm) >240
Paclitaxel, 6mg/ml (6,000ppm) >240
Paraplatin, 1Omg/ml (10,000ppm) >240
Retrovir, 1Omg/ml (10,000ppm) >240
Rituximab, 1Omg/ml (10,000ppm) >240
Thio Tepa, 10mg/ml (10,000ppm) 21.6
Topotecan, 1mg/ml (1,000ppm) >240
Trisenox, lmg/ml (1,000ppm) >240
Velcade, 1mg/ml (1,000ppm) >240
Vincristine Sulfate, lmg/ml (1,000ppm) >240
Fentanyl Citrate Injection (100 mcg/2ml) >240
Please note that the following drugs have extremely low permeation times:
Carmustine: 11.1 minutes, Thio Tepa: 21.6 minutes
*Warning: Do not use with Carmustine and Thio Tepa.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221269 · printed Nov 4, 2026
Cite this page
510(k) Report. “K221269: Powder Free Nitrile Examination Gloves (Blue),Tested for Use with Chemotherapy Drugs and Fentanyl Citrate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K221269
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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