510(k) · Cleared
ClearedPearlescent Powder Free Nitrile Examination Glove with Aloe Vera (Yellow, Red, Green, Black, Blue)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shen Wei (Usa), Inc. · LZC Medical Glove, Specialty
Cleared on Nov 17, 2010 as substantially equivalent to K092411 (Shen Wei (Usa), Inc., 2009) and 1 other predicate after a 177-day review. Its family tree reaches back 1 generation to 2003.
- Decided
- Nov 17, 2010
- Review
- 177 days
- Class
- Class I
- Product code
- LZC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K032024 (2003). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK032024 Powder-Free Nitrile Examination Gloves, Blue Color (Tested for Use…Shen Wei (Usa), Inc. · 2003
- This deviceK101436 Pearlescent Powder Free Nitrile Examination Glove with Aloe Vera…Shen Wei (Usa), Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K032024 | Powder-Free Nitrile Examination Gloves, Blue Color (Tested for Use with… | Shen Wei (Usa), Inc. | 2003 | — |
| 0 (this device) | K101436 | Pearlescent Powder Free Nitrile Examination Glove with Aloe Vera (Yellow, Red… | Shen Wei (Usa), Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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? (2)
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 |
|---|---|---|---|
| * | K092411 | Pearlescent Powder Free Nitrile Examination Gloves with Aloe Vera (Yellow, Red, Green…Summary page 1…scent® Pigment, Powder Free Nitrile Examination Gloves with Aloe Vera Regulatory Class I Nitrile patient examination Product code: 8OLZA 5 10(k): K092411 4.0 Description of the Device: Blue and Red with Pearlescent® Pigment, Powder Free Nitrite Examination Gloves with Aloe… | 2009 |
| * | K032024 | Powder-Free Nitrile Examination Gloves, Blue Color (Tested for Use with Chemotherapy…Summary page 3…ssion: Characteristic and Shen Wei USA Shen Wei USA Substantial parameters INC. (New Device) INC. K032024 Equivalence (SE) Product Code LZA LZA Indented Use… | 2003 |
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?
- None of the 2 ancestors has a recall.
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?
A disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is single use only. Tested for use with chemotherapy drugs. Tested chemotherapy drugs are as follows (Fluorouracil, Etoposide, Cyclophosphamide, Carmustine, Thio-Tepa, Paclitaxel, Doxorubicin Hydrochloride, Dacarbazine, Cisplatin) Chemotherapy Drug Permeation (Breakthrough Detection Time) in Minutes. The…
Read the full statement (260 words)
A disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is single use only. Tested for use with chemotherapy drugs. Tested chemotherapy drugs are as follows (Fluorouracil, Etoposide, Cyclophosphamide, Carmustine, Thio-Tepa, Paclitaxel, Doxorubicin Hydrochloride, Dacarbazine, Cisplatin)
Chemotherapy Drug Permeation (Breakthrough Detection Time) in Minutes.
The following chemicals have been tested with these gloves.
Cyclophosphamide >240
Doxorubicin HCl (Adriamycin) >240
*Carmustine 2.10
Etoposide >240
Fluorouracil (Adrucil) >240
Paclitaxel (Taxol) >240
*ThioTEPA 27.17
Dacarbazine >240
Cisplatin >240
Please note that the following drugs have extremely low permeation times of less than 30 minutes, Carmustine has an average breakthrough time of 2.10 minutes. Thiotepa has an average breakthrough time of 27.17 minutes.
A disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is single use only. Tested for use with chemotherapy drugs. Tested chemotherapy drugs are as follows (Fluorouracil, Etoposide, Cyclophospharnide, Carmustine, Thio-Tepa, Paclitaxel, Doxorubicin Hydrochloride, Dacarbazine, Cisplatin)
Chemotherapy Drug Permeation (Breakthrough Detection Time) in Minutes.
The following chemicals have been tested with these gloves.
Cyclophosphamide >240
Doxorubicin HC1 (Adriamycin) >240
*Carmustine 0.68
Etoposide >240
Fluorouracil (Adrucil) >240
Paclitaxel (Taxol) >240
*ThioTEPA 34.21
Dacarbazine >240
Cisplatin >240
Please note that the following drug have extremely low permeation times of less than 30 minutes, Carmustine has an average breakthrough time of 0.68 minutes.
Please note that the following drug have extremely low permeation times of less than 60 minutes, Thiotepa has an average breakthrough time of 34.21 minutes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101436 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101436: Pearlescent Powder Free Nitrile Examination Glove with Aloe Vera (Yellow, Red, Green, Black, Blue).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101436
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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