510(k) · Cleared
ClearedSynthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shandong Baisheng Medical Products Co., Ltd. · LZA Polymer Patient Examination Glove
Cleared on Nov 21, 2016 as substantially equivalent to K141623 (Eco Medi Glove Sdn. Bhd., 2014) after a 129-day review. Its family tree reaches back 3 generations to 2002.
- Decided
- Nov 21, 2016
- Review
- 129 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K022765 (2002). No later device cites it as a predicate yet.
- Root · 3 generations backK022765 Nitrile Powder-Free Examination GlovesAllegiance Healthcare Corp. · 2002
- 2 generations backK110921 Nitrile Powder-Free Examination Gloves Tested for Use with…Cardinal Health, Inc. · 2011
- 1 generation backK141623 Emg Blue Nitrile Medical Examination Glove with Chemotherapy Drug…Eco Medi Glove Sdn. Bhd. · 2014
- This deviceK161944 Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue…Shandong Baisheng Medical Products Co., Ltd. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K022765 | Nitrile Powder-Free Examination Gloves | Allegiance Healthcare Corp. | 2002 | — |
| −2 | K110921 | Nitrile Powder-Free Examination Gloves Tested for Use with Chemotherapy Drugs | Cardinal Health, Inc. | 2011 | — |
| −1 | K141623 | Emg Blue Nitrile Medical Examination Glove with Chemotherapy Drug Labeling Claim | Eco Medi Glove Sdn. Bhd. | 2014 | — |
| 0 (this device) | K161944 | Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and… | Shandong Baisheng Medical Products Co., Ltd. | 2016 | — |
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 |
|---|---|---|---|
| * | K141623 | Emg Blue Nitrile Medical Examination Glove with Chemotherapy Drug Labeling ClaimSummary page 5…(d Shandong Baisheng Medical Products Co., Ltd. 11 Longshan Road, Wolong Industry Park Linqu, Shandong, China Tel: 0086-536-7510508 Predicate Devices: K141623 - Eco Medi Glove SDN BHD. EMG Blue Nitrile Examination Gloves Powder Free with Tested for Use with Chemotherapy Drugs Reason for… | 2014 |
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 14 years and passes through 4 companies; a new generation was cleared every 3.5 years on median.
- None of the 3 ancestors has a recall.
- 2 other devices also cite its predicate K141623.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Chemotherapy Drug and Minimum Breakthrough Detection Concentration Time ( Minutes )…
Read the full statement (148 words)
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Chemotherapy Drug and Minimum Breakthrough Detection
Concentration Time ( Minutes )
I, Carmustine (BCNU) (3.3 mg/ml) 13.6
2. Cisplastin, (1.0 mg/ml) >240
3. Cyclophosphamide (20 mg/ml) >240
4, Doxorubicin HCI (2.0 mg/ml) >240
5. Etoposide (Toposar) (20 mg/ml) >240
6. Fluorouracil (50 mg/ml) >240
7. Methotrexate (25 mg/ml) >240
8. Mitomycein C (0.5 mg/ml) >240
9. Paclitaxel (Taxol) (6.0 mg/ml) >240
10. Thiotepa (10 mg/ml) 26.9
11, Vincristine Sulfate (1 mg/ml) . >24()
Please note the following drugs, Carmustine and Thiotepa, have extremely low permeation times of 13.6 and 26.9 minutes, respectively.
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/K161944 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161944: Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161944
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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