510(k) · Cleared
ClearedNon-Sterile Powder-Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sgmp Co., Ltd. · LZC Medical Glove, Specialty
Cleared on Nov 19, 2010 as substantially equivalent to K082957 (Siam Sempermed Corp., Ltd., 2009) after a 142-day review. Its family tree reaches back 1 generation to 2009. 5 later devices descend from it.
- Decided
- Nov 19, 2010
- Review
- 142 days
- Class
- Class I
- Product code
- LZC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K082957 (2009). 5 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK082957 Non-Sterile, Powder Free Nitrile Examination Glove, Blue Color…Siam Sempermed Corp., Ltd. · 2009
- This deviceK101822 Non-Sterile Powder-Free Blue Nitrile Examination Gloves Tested for…Sgmp Co., Ltd. · 2010
- Descendant · cites it directly · 4 of its ownK111248 Non-Sterile, Powder-Free Nitrile Examination Gloves (Original Blue…Yty Industry (Manjung) Sdn Bhd · 2011
- Descendant · 2 generations on · 1 of its ownK211810 Shamrock Powder Free Blue Nitrile Examination Gloves (Tested for use…Pt. Shamrock Manufacturing Corpora · 2022
- Descendant · 2 generations on · 1 of its ownK193666 Powder-Free Blue Nitrile Examination Gloves (Tested for use with…Medline Industries, Inc. · 2020
- Descendant · 3 generations on · 0 of its ownK243796 GLOVEONE™ Powder-Free Nitrile Examination Gloves – Non-sterile…Glove One, LLC · 2025
- Descendant · 3 generations on · 0 of its ownK232064 Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use…Isikel Manufacturing, LLC · 2023
Most influential descendants
Showing 5 of 5 · See all- K111248Non-Sterile, Powder-Free Nitrile Examination Gloves (Original Blue, Cobalt Blue)Yty Industry (Manjung) Sdn Bhd · 2011 · cites it directly4descendants
- K211810Shamrock Powder Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy…Pt. Shamrock Manufacturing Corpora · 2022 · 2 generations on1descendant
- K193666Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy and…Medline Industries, Inc. · 2020 · 2 generations on1descendant
- K243796GLOVEONE™ Powder-Free Nitrile Examination Gloves – Non-sterile [Tested for use with…Glove One, LLC · 2025 · 3 generations on0descendants
- K232064Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with Chemotherapy…Isikel Manufacturing, LLC · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K082957 | Non-Sterile, Powder Free Nitrile Examination Glove, Blue Color, Polymer… | Siam Sempermed Corp., Ltd. | 2009 | — |
| 0 (this device) | K101822 | Non-Sterile Powder-Free Blue Nitrile Examination Gloves Tested for Use with… | Sgmp Co., Ltd. | 2010 | — |
| +1 | K111248 | Non-Sterile, Powder-Free Nitrile Examination Gloves (Original Blue, Cobalt Blue) | Yty Industry (Manjung) Sdn Bhd | 2011 | — |
| +2 | K211810 | Shamrock Powder Free Blue Nitrile Examination Gloves (Tested for use with… | Pt. Shamrock Manufacturing Corpora | 2022 | — |
| +2 | K193666 | Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy… | Medline Industries, Inc. | 2020 | — |
| +3 | K243796 | GLOVEONE™ Powder-Free Nitrile Examination Gloves – Non-sterile [Tested for use… | Glove One, LLC | 2025 | — |
| +3 | K232064 | Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with… | Isikel Manufacturing, LLC | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K082957 | Non-Sterile, Powder Free Nitrile Examination Glove, Blue Color, Polymer Coated, Tested…Summary page 3…se Tested fir use with Chemnotherapy with Chemtep Drugs Drugs 510 K# K082957 Devise Class 11SE Product Code LZA LZA… | 2009 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111248 | Non-Sterile, Powder-Free Nitrile Examination Gloves (Original Blue, Cobalt Blue) | 2011 | 4 |
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?
- Its one ancestor has no recall.
- Of its descendants, K111248 (Yty Industry (Manjung) Sdn Bhd, 2011) has gone furthest, with 4 descendants of its own.
How does its category compare?
All LZC devicesLZC Medical Glove, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
The Non-sterile Powder Free Blue Nitrile Examination Gloves Tested for use with Chemotherapy Drugs, is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and examiner. Chemotherapy Drug Permeation (Breakthrough Detection Time) in Minutes The following chemical have been tested with these gloves. Test Chemotherapy Drug — Average Breakthrough Detection Time (Minutes)…
Read the full statement (132 words)
The Non-sterile Powder Free Blue Nitrile Examination Gloves Tested for use with Chemotherapy Drugs, is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and examiner.
Chemotherapy Drug Permeation (Breakthrough Detection Time) in Minutes
The following chemical have been tested with these gloves.
Test Chemotherapy Drug — Average Breakthrough Detection Time (Minutes)
Carmustine (BCNU) — 0.49 minutes*
Cisplatin — >240 minutes
Cyclophosphamide — >240 minutes
Doxorubicin Hydrochloride — >240 minutes
Etoposide (Toposar) — >240 minutes
Flurouracil — >240 minutes
Paclitaxel (Taxol) — >240 minutes
Thiotepa — 2.61 minutes*
Vincristine Sulfate — >240 minutes
Dacarbazine (DTIC) — >240 minutes
Methotrexate — >240 minutes
*Please note that Carmustine (BCNU) and Thiotepa have extremely low permeation times of 0.49 and 2.61 minute only.
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/K101822 · printed Nov 5, 2026
Cite this page
510(k) Report. “K101822: Non-Sterile Powder-Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K101822
Report an extraction error
Are you the manufacturer?
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