510(k) · Cleared
ClearedPowder Free Nitrile Examination Glove (Grey) 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 Aug 7, 2023 as substantially equivalent to K221269 (Better Care Plastic Technology Co., Ltd., 2022) after a 238-day review. Its family tree reaches back 3 generations to 2019. 1 later device descends from it.
- Decided
- Aug 7, 2023
- Review
- 238 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K183287 (2019). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK183287 Powder Free Nitrile Patient Examination Glove, Blue Colored…Kossan International Sdn Bhd · 2019
- 2 generations backK192954 Power Free Nitrile Examination Gloves Tested for Use with…Comfort Rubber Gloves Industries Sdn. Bhd. · 2020
- 1 generation backK221269 Powder Free Nitrile Examination Gloves (Blue),Tested for Use with…Better Care Plastic Technology Co., Ltd. · 2022
- This deviceK223713 Powder Free Nitrile Examination Glove (Grey) Tested for Use with…Better Care Plastic Technology Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK233598 Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile…Anhui Intco Medical Products Co., Ltd. · 2024
Most influential descendants
Showing 1 of 1 · See all- K233598Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use…Anhui Intco Medical Products Co., Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K183287 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile… | Kossan International Sdn Bhd | 2019 | — |
| −2 | K192954 | Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs… | Comfort Rubber Gloves Industries Sdn. Bhd. | 2020 | — |
| −1 | K221269 | Powder Free Nitrile Examination Gloves (Blue),Tested for Use with Chemotherapy… | Better Care Plastic Technology Co., Ltd. | 2022 | — |
| 0 (this device) | K223713 | Powder Free Nitrile Examination Glove (Grey) Tested for Use with Chemotherapy… | Better Care Plastic Technology Co., Ltd. | 2023 | — |
| +1 | K233598 | Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested… | Anhui Intco Medical Products Co., Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 |
|---|---|---|---|
| * | K221269 | Powder Free Nitrile Examination Gloves (Blue),Tested for Use with Chemotherapy Drugs and…Summary page 5…Predicate Device: Better Care Plastic Technology Co., Ltd. Powder Free Nitrile Examination Gloves (Blue) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K221269) Reference device: O & M Halyard, Inc. Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitrile Sensi-… | 2022 |
| † | K191230 | Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitrile… | 2019 |
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 |
|---|---|---|---|
| K233598 | Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use… | 2024 | 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 4 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K233598 (Anhui Intco Medical Products Co., Ltd., 2024) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K221269.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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. Chemotherapy Drug and Concentration Minimum Breakthrough Detection Time (Minutes) Arsenic Trioxide (1 mg/ml) >240 Azacitidine (25 mg/ml) >240 Bendamustine HCL (5 mg/ml) >240 Bleomycin sulfate (15 mg/ml) >240 Bortezomib (1…
Read the full statement (317 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.
Chemotherapy Drug and Concentration Minimum Breakthrough Detection Time (Minutes)
Arsenic Trioxide (1 mg/ml) >240
Azacitidine (25 mg/ml) >240
Bendamustine HCL (5 mg/ml) >240
Bleomycin sulfate (15 mg/ml) >240
Bortezomib (1 mg/ml) >240
Busulfan (6 mg/ml) >240
Carboplatin (10 mg/ml) >240
Carfilzomib (2 mg/ml) >240
Carmustine (3.3 mg/ml) 13.9
Cetuximab (2 mg/ml) >240
Cisplatin (1 mg/ml) >240
Cyclophosphamide (20 mg/ml) >240
Cytarabine (Cytosine) (100 mg/ml) >240
Cytovene (10 mg/ml) >240
Dacarbazine (DTIC) (10 mg/ml) >240
Daunorubicin HCL (5 mg/ml) >240
Decitabine (5-Aza-2’-deoxycytidine) (5 mg/ml) >240
Docetaxel (10 mg/ml) >240
Doxorubicin Hydrochloride (2 mg/ml) >240
Epirubicin HCL(Ellence) (2 mg/ml) >240
Eribulin Mesylate (0.5 mg/ml) >240
Etoposide (Toposar) (20 mg/ml) >240
Fludarabine (25 mg/ml) >240
5-Fluorouracil (50 mg/ml) >240
Fulvestrant (50 mg/ml) >240
Gemcitabine (38 mg/ml) >240
Idarubicin (1.0 mg/ml) >240
Ifosfamide (50 mg/ml) >240
Irinotecan HCL (20 mg/ml) >240
Mechlorethamine HCL (1 mg/ml) >240
Melphalan (5 mg/ml) >240
Methotrexate (25 mg/ml) >240
Mitomycin-C (0.5 mg/ml) >240
Mitoxantrone (2 mg/ml) >240
Oxaliplatin (2 mg/ml) >240
Paclitaxel (6 mg/ml) >240
Paraplatin (10 mg/ml) >240
Pemetrexed (25 mg/ml) >240
Pertuzumab (30 mg/ml) >240
Raltitrexed monohydrate (0.5 mg/ml) >240
Retrovir (10 mg/ml) >240
Rituximab (10 mg/ml) >240
Temsirolimus (25 mg/ml) >240
Thiotepa (10 mg/ml) 44.4
Topotecan HCL (1 mg/ml) >240
Trastuzumab (21 mg/ml) >240
Trisenox (1 mg/ml) >240
Vinblastine (1 mg/ml) >240
Vincrinstine Sulfate (1 mg/ml) >240
Vinorelbine (10 mg/ml) >240
Zoledronic Acid (0.8 mg/ml) >240
Fentanyl Citrate and Concentration Minimum Breakthrough Detection Time (Minutes)
Fentanyl Citrate Injection (100mcg/2mL) >240
Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution >240
*Please note that the following drugs have extremely low permeation times:
Carmustine: 13.9 minutes, Thio Tepa: 44.4 minutes
Warning: Do not use with Carmustine and Thio Tepa.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223713 · printed Nov 5, 2026
Cite this page
510(k) Report. “K223713: Powder Free Nitrile Examination Glove (Grey) 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 5, 2026. https://510kreport.com/device/K223713
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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