510(k) · Cleared
ClearedJR Medic
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jr Engineering & Medical Technologies (M) Sdn. Bhd. · LZC Medical Glove, Specialty
Cleared on Aug 30, 2022 as substantially equivalent to K121926 (Northstar Healthcare Holdings, 2012) after a 131-day review. Its family tree reaches back 3 generations to 1999.
- Decided
- Aug 30, 2022
- Review
- 131 days
- Class
- Class I
- Product code
- LZC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K972615 (1999). No later device cites it as a predicate yet.
- Root · 3 generations backK972615 Chemo Plus Powder Free Blue Latex Examination Gloves (Protein…Wembley Rubber Products (M) Sdn Bhd · 1999 · Recalled
- 2 generations backK083409 Powder Free Blue Latex Patient Examination Gloves, Tested for Use…Wrp Asia Pacific Sdn. Bhd. · 2009
- 1 generation backK121926 Blue, Latex Powder Free Examination Gloves, Tested for Use with…Northstar Healthcare Holdings · 2012
- This deviceK221157 JR MedicJr 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 |
|---|---|---|---|---|---|
| −3 | K972615 | Chemo Plus Powder Free Blue Latex Examination Gloves (Protein Content Labeling) | Wembley Rubber Products (M) Sdn Bhd | 1999 | 3 |
| −2 | K083409 | Powder Free Blue Latex Patient Examination Gloves, Tested for Use with… | Wrp Asia Pacific Sdn. Bhd. | 2009 | — |
| −1 | K121926 | Blue, Latex Powder Free Examination Gloves, Tested for Use with Chemotherapy… | Northstar Healthcare Holdings | 2012 | — |
| 0 (this device) | K221157 | JR Medic | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | 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 |
|---|---|---|---|
| * | K121926 | Blue, Latex Powder Free Examination Gloves, Tested for Use with Chemotherapy Drugs with…Summary page 5…Labeling Claim (50µg/dm² or Less of Water Soluble Protein) 510( K) Number K121926 Regulatory Class 1 Product code LZC D. DESCRIPTION OF THE DEVICE: The subject… | 2012 |
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 23 years and passes through 4 companies; a new generation was cleared every 9.9 years on median.
- 1 of the 3 ancestors has a recall of any class.
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?
JR Medic Blue Latex Examination Powder Free Gloves Tested for use with Chemotherapy drugs are 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 in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical Glove to Permeation by Chemotherapy Drugs. The tested chemotherapy drugs…
Read the full statement (160 words)
JR Medic Blue Latex Examination Powder Free Gloves Tested for use with Chemotherapy drugs are 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 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:
Tested Chemotherapy Drug Name & Concentration
Carmustine (BCNU) (3.3 mg/ml)
Carboplatin (10 mg/ml)
Cisplatin (1 mg/ml)
Cyclophosphamide (Cytoxan) (20 mg/ml)
Dacarbazine (10.0 mg/ml)
Doxorubicin HCI (2 mg/ml)
Etoposide (20 mg/ml)
Fluorouracil (50 mg/ml)
Ifosfamide (50 mg/ml)
Methotrexate (25 mg/ml)
Mitomycin C (0.5 mg/ml)
Mitoxantrone (2 mg/ml)
Paclitaxel (6 mg/ml)
Thiotepa (10 mg/ml)
Vincristine Sulfate (1 mg/ml)
Please note that the following drugs have low permeation times:
Carmustine (BCNU) (3.3 mg/ml) 23.8 Minutes
Thiotepa (10 mg/ml) 24.1 Minutes
Warning: Do not use with Carmustine or Thiotepa.
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/K221157 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221157: JR Medic.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221157
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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