510(k) · Cleared
ClearedPowder Free Nitrile Examination Glove, Tested for Use with Chemoterapy Drugs (Blue)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Harbour Health, LLC · LZA Polymer Patient Examination Glove
Cleared on Apr 29, 2021 as substantially equivalent to K182600 (Better Care Plastic Technology Co., Ltd., 2018) after a 30-day review. Its family tree reaches back 7 generations to 2004. 5 later devices descend from it.
- Decided
- Apr 29, 2021
- Review
- 30 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K042805 (2004). 8 ancestors in all. 5 later devices descend from it, 4 citing it directly.
- Root · 7 generations backK042805 Powder Free Nitrile Patient Examination Gloves, Blue Colored…Perusahaan Getah Asas Sdn. Bhd. · 2004
- 6 generations backK081089 Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam…Kimberly-Clark Corp. · 2008
- 5 generations backK141982 Dermagrip Powder Free Blue Nitrile Patient Examination Gloves…Wrp Asia Pacific Sdn. Bhd. · 2015
- 4 generations backK163146 POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy…Hebei Hongsen Plastics Technology Co, Ltd. · 2017
- 3 generations backK172525 Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for…Central Medicare Sdn Bhd · 2017
- 2 generations backK173942 Blue Non Sterile powder free Nitrile Examination Gloves Tested for…Central Medicare Sdn Bhd · 2018
- 1 generation backK182600 Powder Free Nitrile Examination Glove, Tested for Use with…Better Care Plastic Technology Co., Ltd. · 2018
- This deviceK210944 Powder Free Nitrile Examination Glove, Tested for Use with…Harbour Health, LLC · 2021
- Descendant · cites it directly · 1 of its ownK213227 Powder free Nitrile Examination Glove-(Test for use with…Uweport, LLC · 2022
- Descendant · 2 generations on · 0 of its ownK221350 Non-Sterile Powder Free Nitrile Examination Gloves (Tested for Use…Rubberex Alliance Products Sdn Bhd · 2022
- Descendant · cites it directly · 0 of its ownK213076 AspenMed+Aspen Glove Sdn. Bhd. · 2021
- Descendant · cites it directly · 0 of its ownK212898 Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile…Rimba Glove Snd Bhd · 2021
- Descendant · cites it directly · 0 of its ownK212827 Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use…Jr Engineering & Medical Technologies (M) Sdn. Bhd. · 2021
Most influential descendants
Showing 5 of 5 · See all- K213227Powder free Nitrile Examination Glove-(Test for use with Chemotherapy Drugs)Uweport, LLC · 2022 · cites it directly1descendant
- K221350Non-Sterile Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy…Rubberex Alliance Products Sdn Bhd · 2022 · 2 generations on0descendants
- K213076AspenMed+Aspen Glove Sdn. Bhd. · 2021 · cites it directly0descendants
- K212898Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With…Rimba Glove Snd Bhd · 2021 · cites it directly0descendants
- K212827Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy…Jr Engineering & Medical Technologies (M) Sdn. Bhd. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K042805 | Powder Free Nitrile Patient Examination Gloves, Blue Colored Non-Sterile | Perusahaan Getah Asas Sdn. Bhd. | 2004 | — |
| −6 | K081089 | Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam Gloves with… | Kimberly-Clark Corp. | 2008 | — |
| −5 | K141982 | Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile… | Wrp Asia Pacific Sdn. Bhd. | 2015 | — |
| −4 | K163146 | POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs | Hebei Hongsen Plastics Technology Co, Ltd. | 2017 | — |
| −3 | K172525 | Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with… | Central Medicare Sdn Bhd | 2017 | — |
| −2 | K173942 | Blue Non Sterile powder free Nitrile Examination Gloves Tested for Use with… | Central Medicare Sdn Bhd | 2018 | — |
| −1 | K182600 | Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs… | Better Care Plastic Technology Co., Ltd. | 2018 | — |
| 0 (this device) | K210944 | Powder Free Nitrile Examination Glove, Tested for Use with Chemoterapy Drugs… | Harbour Health, LLC | 2021 | — |
| +1 | K213227 | Powder free Nitrile Examination Glove-(Test for use with Chemotherapy Drugs) | Uweport, LLC | 2022 | — |
| +2 | K221350 | Non-Sterile Powder Free Nitrile Examination Gloves (Tested for Use with… | Rubberex Alliance Products Sdn Bhd | 2022 | — |
| +1 | K213076 | AspenMed+ | Aspen Glove Sdn. Bhd. | 2021 | — |
| +1 | K212898 | Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For… | Rimba Glove Snd Bhd | 2021 | — |
| +1 | K212827 | Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with… | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 3 | 0 |
| 2022 | 2 | 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 |
|---|---|---|---|
| * | K182600 | Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue) | 2018 |
What descends from it? (5)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213227 | Powder free Nitrile Examination Glove-(Test for use with Chemotherapy Drugs) | 2022 | 1 |
| K213076 | AspenMed+ | 2021 | 0 |
| K212898 | Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With… | 2021 | 0 |
| K212827 | Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy… | 2021 | 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 17 years and passes through 7 companies; a new generation was cleared every 2.0 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K213227 (Uweport, LLC, 2022) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K182600.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
A patient examination 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 per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. Chemotherapy Drug Permeation: No. Chemotherapy Drug Tested Concentration Breakthrough…
Read the full statement (263 words)
A patient examination 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 per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
Chemotherapy Drug Permeation:
No. Chemotherapy Drug Tested Concentration Breakthrough Detection Time (Minutes)
1 Busulfan 6 mg/ml (6,000 ppm) > 240
2 Carboplatin 10 mg/ml (10,000 ppm) > 240
3 Carmustine (BCNU) 3.3 mg/ml (3,300 ppm) 14.5*
4 Cisplatin 1.0 mg/ml (1,000 ppm) > 240
5 Cyclophosphamide (Cytoxan) 20.0 mg/ml (20,000 ppm) > 240
6 Cytarabine 100 mg/ml (100,000 ppm) > 240
7 Dacarbazine 10.0 mg/ml (10,000 ppm) > 240
8 Docetaxel 10 mg/ml (10,000 ppm) > 240
9 Doxorubicin HCI 2.0 mg/ml (2,000 ppm) > 240
10 Etoposide 20.0 mg/ml (20,000 ppm) > 240
11 Fluorouracil 50.0 mg/ml (50,000 ppm) > 240
12 Ifosfamide 50 mg/ml (50,000 ppm) > 240
13 Mechlorethamine HCI 1 mg/ml (1,000 ppm) > 240
14 Methotrexate 25 mg/ml (25,000 ppm) > 240
15 Mitomycin C 0.5 mg/ml (500 ppm) > 240
16 Mitoxantrone 2 mg/ml (2,000 ppm) > 240
17 Paclitaxel 6.0 mg/ml (6,000 ppm) > 240
18 Thiotepa 10.0 mg/ml (10,000 ppm) 47.4*
19 Vincristine Sulfate 1.0 mg/ml (1,000 ppm) > 240
*WARNING: Not recommended for use with Carmustine and Thiotepa.
The maximum testing time is 240 minutes. Please note that the following drugs have low permeation times:
Carmustine (BCNU) 3.3 mg/ml (3,300 ppm) 14.5 minutes
Thiotepa 10.0 mg/ml (10,000 ppm) 47.4 minutes
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210944 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210944: Powder Free Nitrile Examination Glove, Tested for Use with Chemoterapy Drugs (Blue).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210944
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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