510(k) · Cleared
ClearedJr Medic Blue Nitrile Examination Gloves Powder Free 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
Jr Engineering & Medical Technologies (M) Sdn. Bhd. · LZA Polymer Patient Examination Glove
Cleared on Dec 7, 2022 as substantially equivalent to K202622 (O&M Halyard, Inc., 2021) after a 184-day review. Its family tree reaches back 7 generations to 2004.
- Decided
- Dec 7, 2022
- Review
- 184 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. No later device cites it as a predicate yet.
- 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 backK180646 Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with…Halyard Health · 2018
- 1 generation backK202622 Halyard Lavender, Low Dermatitis Potential, Powder-Free Exam Gloves…O&M Halyard, Inc. · 2021
- This deviceK221626 Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use…Jr Engineering & Medical Technologies (M) Sdn. Bhd. · 2022
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 | K180646 | Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with… | Halyard Health | 2018 | — |
| −1 | K202622 | Halyard Lavender, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for… | O&M Halyard, Inc. | 2021 | — |
| 0 (this device) | K221626 | Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with… | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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 |
|---|---|---|---|
| * | K202622 | Halyard Lavender, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with…Summary page 5…Tested for use with Chemotherapy Drugs and Fentanyl Citrate 510( K) Number K202622 Regulatory Class 1 Product code LZC, QDO D. DESCRIPTION OF THEDEVICE: The… | 2021 |
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 18 years and passes through 8 companies; a new generation was cleared every 2.0 years on median.
- None of the 8 ancestors has a recall.
- 1 other device also cites its predicate K202622.
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?
Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl Citrate is a disposable device intended for medical purpose that is worn on the examiner’s hand to prevent contamination between patient and examiner. Additionally, the gloves were tested for use with chemotherapy drugs and Fentanyl Citrate in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical Glove to Permeation by…
Read the full statement (366 words)
Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl Citrate is a disposable device intended for medical purpose that is worn on the examiner’s hand to prevent contamination between patient and examiner.
Additionally, the gloves were tested for use with chemotherapy drugs and Fentanyl Citrate in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical Glove to Permeation by Chemotherapy Drugs.
The tested chemotherapy drugs and their breakthrough detection times are as follows:
Bendamustine (5 mg/ml) >240 Minutes
Bleomycin (15 mg/ml) >240 Minutes
Busulfan (6 mg/ml) >240 Minutes
Carfilzomib (2 mg/ml) >240 Minutes
Cetuximab (2 mg/ml) >240 Minutes
Cladribine (1 mg/ml) >240 Minutes
Cytarabine (100 mg/ml) >240 Minutes
Daunorubicin HCl (5 mg/ml) >240 Minutes
Decitabine (5 mg/ml) >240 Minutes
Docetaxel (10 mg/ml) >240 Minutes
Epirubicin HCl (2 mg/ml) >240 Minutes
Fludarabine (25 mg/ml) >240 Minutes
Fulvestrant (50 mg/ml) >240 Minutes
Gemcitabine (38 mg/ml) >240 Minutes
Idarubicin HCl (1 mg/ml) >240 Minutes
Irinotecan (20 mg/ml) >240 Minutes
Mechlorethamine (1 mg/ml) >240 Minutes
Melphalan (5 mg/ml) >240 Minutes
Oxaliplatin (5 mg/ml) >240 Minutes
Paraplatin (10 mg/ml) >240 Minutes
Pemetrexed (25 mg/ml) >240 Minutes
Raltitrexed (0.5 mg/ml) >240 Minutes
Rituximab (10 mg/ml) >240 Minutes
Topotecan (1 mg/ml) >240 Minutes
Triclosan (2 mg/ml) >240 Minutes
Trisenox (1 mg/ml) >240 Minutes
Velcade (Bortezomib) (1 mg/ml) >240 Minutes
Vidaza (Azacytidine) (25 mg/ml) >240 Minutes
Vinblastine (1 mg/ml) >240 Minutes
Vinorelbine (10 mg/ml) >240 Minutes
Carmustine (BCNU) (3.3 mg/ml) 35.0 Minutes
Carboplatin (10 mg/ml) >240 Minutes
Cisplatin (1 mg/ml) >240 Minutes
Cyclophosphamide (Cytoxan) (20 mg/ml) >240 Minutes
Dacarbazine (10.0 mg/ml) >240 Minutes
Doxorubicin HCl (2 mg/ml) >240 Minutes
Etoposide (20 mg/ml) >240 Minutes
Fluorouracil (50 mg/ml) >240 Minutes
Ifosfamide (50 mg/ml) >240 Minutes
Methotrexate (25 mg/ml) >240 Minutes
Mitomycin C (0.5 mg/ml) >240 Minutes
Mitoxantrone (2 mg/ml) >240 Minutes
Paclitaxel (6 mg/ml) >240 Minutes
Thiotepa (10 mg/ml) 64.9 Minutes
Vincristine Sulfate (1 mg/ml) >240 Minutes
The following hazardous drugs (opioid) and concentration had no breakthrough detected up to 240 minutes:
Fentanyl Citrate Injection (100 mcg/2ml)
Please note that the following drugs have low permeation times:
Carmustine (BCNU) (3.3 mg/ml) 35.0 Minutes
Thiotepa (10 mg/ml) 64.9 Minutes
Warning: Do not use with Carmustine or Thiotepa.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221626 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221626: Jr Medic Blue Nitrile Examination Gloves Powder Free 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 6, 2026. https://510kreport.com/device/K221626
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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