510(k) · Cleared
ClearedDisposable Medical Nitrile Examination Gloves (Non sterile)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jiangsu Nanfang Medical Co., Ltd. · LZC Medical Glove, Specialty
Cleared on Dec 8, 2021 as substantially equivalent to K172525 (Central Medicare Sdn Bhd, 2017) after a 110-day review. Its family tree reaches back 5 generations to 2004.
- Decided
- Dec 8, 2021
- Review
- 110 days
- Class
- Class I
- Product code
- LZC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K042805 (2004). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK042805 Powder Free Nitrile Patient Examination Gloves, Blue Colored…Perusahaan Getah Asas Sdn. Bhd. · 2004
- 4 generations backK081089 Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam…Kimberly-Clark Corp. · 2008
- 3 generations backK141982 Dermagrip Powder Free Blue Nitrile Patient Examination Gloves…Wrp Asia Pacific Sdn. Bhd. · 2015
- 2 generations backK163146 POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy…Hebei Hongsen Plastics Technology Co, Ltd. · 2017
- 1 generation backK172525 Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for…Central Medicare Sdn Bhd · 2017
- This deviceK212639 Disposable Medical Nitrile Examination Gloves (Non sterile)Jiangsu Nanfang Medical Co., Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K042805 | Powder Free Nitrile Patient Examination Gloves, Blue Colored Non-Sterile | Perusahaan Getah Asas Sdn. Bhd. | 2004 | — |
| −4 | K081089 | Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam Gloves with… | Kimberly-Clark Corp. | 2008 | — |
| −3 | K141982 | Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile… | Wrp Asia Pacific Sdn. Bhd. | 2015 | — |
| −2 | K163146 | POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs | Hebei Hongsen Plastics Technology Co, Ltd. | 2017 | — |
| −1 | K172525 | Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with… | Central Medicare Sdn Bhd | 2017 | — |
| 0 (this device) | K212639 | Disposable Medical Nitrile Examination Gloves (Non sterile) | Jiangsu Nanfang Medical Co., Ltd. | 2021 | — |
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 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 |
|---|---|---|---|
| * | K172525 | Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy…Summary page 4…tion Gloves Device Class: Class I Device Classification Number: 21 CFR 880.6250 Product Code: LZC LZA 3. IDENTIFICATION OF THE LEGALLY MARKETED DEVICE Predicate Device: K172525 Applicant: Central Medicare Sdn. Bhd Device Name: Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Che… | 2017 |
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 17 years and passes through 6 companies; a new generation was cleared every 3.6 years on median.
- None of the 6 ancestors has a recall.
- 4 other devices also cite its predicate K172525.
How does its category compare?
All LZC devicesLZC Medical Glove, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
Disposable Medical Nitrile Examination Gloves (Non sterile) are a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, these patient examination gloves were tested for use with the following drug concentrations per ASTM D6978-05(2019): The following drugs had NO breakthrough detected up to 240 minutes: Busulfan, Fluorouracil, 6 mg/ml (6,000 ppm) 50.0 mg/ml…
Read the full statement (183 words)
Disposable Medical Nitrile Examination Gloves (Non sterile) are a disposable device intended for medical
purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
In addition, these patient examination gloves were tested for use with the following drug concentrations per
ASTM D6978-05(2019):
The following drugs had NO breakthrough detected up to 240 minutes:
Busulfan, Fluorouracil,
6 mg/ml (6,000 ppm) 50.0 mg/ml (50,000 ppm)
Carboplatin /Paraplatin, lfosfamide,
10 mg/ml (10,000 ppm) 50 mg/ml (50,000 ppm)
Cisplatin, Mechlorethamine HCI,
1.0 mg/ml (1,000 ppm) 1 mg/ml (1,000 ppm)
Cyclophosphamide (Cytoxan), Methotrexate,
20.0 mg/ml (20,000 ppm) 25 mg/ml (25,000 ppm)
Cytarabine HCI, Mitomycin,
100 mg/ml (100,000 ppm) 0.5 mg/ml (500 ppm)
Dacarbazine, Mitoxantrone,
10.0 mg/ml (10,000 ppm) 2 mg/ml (2,000 ppm)
Docetaxel, Paclitaxel,
10 mg/ml (10,000 ppm) 6.0 mg/ml (6,000 ppm)
Doxorubicin HCI, Vincristine Sulfate,
2.0 mg/ml (2,000 ppm) 1 mg/ml (1,000 ppm)
Etoposide,
20.0 mg/ml (20,000 ppm)
Please note that the following drug has low permeation times of less than 60 minutes:
Carmustine (BCNU) 3.3 mg/ml (3,300 ppm), 44.7minutes
ThioTepa10.0 mg/ml (10,000 ppm),35.7 minutes
WARNING: Do not use Carmustine and Thiotepa
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212639 · printed Nov 4, 2026
Cite this page
510(k) Report. “K212639: Disposable Medical Nitrile Examination Gloves (Non sterile).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K212639
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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