510(k) · Cleared
ClearedPowder Free Blue Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl;Powder Free Black Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
S&S Glove Corporation · LZA Polymer Patient Examination Glove
Cleared on Jun 3, 2026 as substantially equivalent to K232266 (Better Care Plastic Technology Co., Ltd., 2023) after a 91-day review. Its family tree reaches back 4 generations to 2019.
- Decided
- Jun 3, 2026
- Review
- 91 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K183287 (2019). No later device cites it as a predicate yet.
- Root · 4 generations backK183287 Powder Free Nitrile Patient Examination Glove, Blue Colored…Kossan International Sdn Bhd · 2019
- 3 generations backK192954 Power Free Nitrile Examination Gloves Tested for Use with…Comfort Rubber Gloves Industries Sdn. Bhd. · 2020
- 2 generations backK221269 Powder Free Nitrile Examination Gloves (Blue),Tested for Use with…Better Care Plastic Technology Co., Ltd. · 2022
- 1 generation backK232266 Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non…Better Care Plastic Technology Co., Ltd. · 2023
- This deviceK260703 Powder Free Blue Nitrile Examination Glove - Tested for Use with…S&S Glove Corporation · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K183287 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile… | Kossan International Sdn Bhd | 2019 | — |
| −3 | K192954 | Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs… | Comfort Rubber Gloves Industries Sdn. Bhd. | 2020 | — |
| −2 | K221269 | Powder Free Nitrile Examination Gloves (Blue),Tested for Use with Chemotherapy… | Better Care Plastic Technology Co., Ltd. | 2022 | — |
| −1 | K232266 | Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile… | Better Care Plastic Technology Co., Ltd. | 2023 | — |
| 0 (this device) | K260703 | Powder Free Blue Nitrile Examination Glove - Tested for Use with Chemotherapy… | S&S Glove Corporation | 2026 | — |
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 |
|---|---|---|---|
| * | K232266 | Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Tested for…Summary page 7…6250 Regulation Name: Non-powdered patient examination glove Review Panel: General Hospital 5. Identification of Predicate Device(s) 510(k) Number: K232266 Product Name: Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Tested for Use with Chemothera… | 2023 |
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 7 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- None of the 4 ancestors has a recall.
- 2 other devices also cite its predicate K232266.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
Powder Free Blue Nitrile Examination Glove- Tested for Use with Chemotherapy Drugs and Fentanyl: The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05. The following chemicals have been tested with these gloves: Chemotherapy Drugs Concentration mg/ml…
Read the full statement (417 words)
Powder Free Blue Nitrile Examination Glove- Tested for Use with Chemotherapy Drugs and Fentanyl:
The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05.
The following chemicals have been tested with these gloves:
Chemotherapy Drugs Concentration mg/ml Breakthrough Detection Time in Minutes
1 Carmustine, 3.3mg/ml (3,300 ppm) 22.7 min
2 Cisplatin, 1mg/ml (1,000 ppm) >240min
3 Cyclophosphamide, 20mg/ml (20,000 ppm) >240min
4 Dacarbazine (DTIC), 10mg/ml (10,000 ppm) >240min
5 Doxorubicin HCI (Adriamycin), 2mg/ml (2,000 ppm) >240min
6 Etoposide (Toposar), 20mg/ml (20,000 ppm) >240min
7 Fluorouracil (5 Flu), 50mg/ml (50,000 ppm) >240min
8 Methotrexate, 25mg/ml (25,000 ppm) >240min
9 Mitomycin C, 0.5 mg/ml (500 ppm) >240min
10 Mitoxantrone HCI, 2mg/ml (2,000 ppm) >240min
11 Paclitaxel (Taxol), 6mg/ml (6,000 ppm) >240min
12 Thio-Tepa, 10mg/ml (10,000 ppm) 11.1 min
13 Vincristine Sulphate, 1mg/ml (1,000 ppm ) >240 min
Non-chemotherapy Drugs Concentration mg/ml Breakthrough Detection Time in Minutes
1 Fentanyl Citrate, 100mcg/2ml >240min
Testing showed an average breakthrough time of 11.1 minutes with Thio-Tepa, 10mg/ml (10,000 ppm) and 22.7 minutes with Carmustine, 3.3mg/ml (3,300 ppm)
Warning: Do not use with Carmustine and Thiotepa
Powder Free Black Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl:
The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05.
The following chemicals have been tested with these gloves:
Chemotherapy Drugs Concentration mg/ml Breakthrough Detection Time in Minutes
1 Carmustine, 3.3mg/ml (3,300 ppm) 21.4 min
2 Cisplatin, 1mg/ml (1,000 ppm) >240min
3 Cyclophosphamide, 20mg/ml (20,000 ppm) >240min
4 Dacarbazine (DTIC), 10mg/ml (10,000 ppm) >240min
5 Doxorubicin HCI (Adriamycin), 2mg/ml (2,000 ppm) >240min
6 Etoposide (Toposar), 20mg/ml (20,000 ppm) >240min
7 Fluorouracil (5 Flu), 50mg/ml (50,000 ppm) >240min
8 Methotrexate, 25mg/ml (25,000 ppm) >240min
9 Mitomycin C, 0.5 mg/ml (500 ppm) >240min
10 Mitoxantrone HCI, 2mg/ml (2,000 ppm) >240min
11 Paclitaxel (Taxol), 6mg/ml (6,000 ppm) >240min
12 Thio-Tepa, 10mg/ml (10,000 ppm) 15.5 min
13 Vincristine Sulphate, 1mg/ml (1,000 ppm ) >240 min
Non-chemotherapy Drugs Concentration mg/ml Breakthrough Detection Time in Minutes
1 Fentanyl Citrate, 100mcg/2ml >240min
Testing showed an average breakthrough time of 15.5 minutes with Thio-Tepa, 10mg/ml (10,000 ppm) and 21.4 minutes with Carmustine, 3.3mg/ml (3,300 ppm).
Warning: Do not use with Carmustine and Thiotepa
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260703 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260703: Powder Free Blue Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl;Powder Free Black Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260703
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026