510(k) · Cleared
ClearedNitrile Blue Powder-free Examination Glove
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardinal Health200, LLC · LZA Polymer Patient Examination Glove
Cleared on Aug 28, 2021 after a 115-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Aug 28, 2021
- Review
- 115 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 on the examiner's hand or finger to prevent contamination between patient and examiner. In addition, these gloves have been tested for resistance to permeation of various chemotherapy drugs per ASTM D6978, “Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs." Chemotherapy Drug Permeation Resistance (minimum…
Read the full statement (618 words)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. In addition, these gloves have been tested for resistance to permeation of various chemotherapy drugs per ASTM D6978, “Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs."
Chemotherapy Drug Permeation Resistance (minimum breakthrough detection time in minutes, 0.01 pg/cm2/min):
1. Azacitidine (VIdAZa) ......cocveevieriiiriiiiieriieiee ettt (25 mg/ml) > 240
2. BeNAAMUSLINEG .....veeviiriieriieitiesiiesiiesiee st e eeesieesteeseee st e sreesneesaeeseeesaeesnnesneesnsesneesneens (5 mg/ml) > 240
3. BIEOIMYCIN ..ottt st (15 mg/ml) > 240
4. Bortezomib (Velcade) ......c.oovieieiiiiiieieeeceee e (1 mg/ml) > 240
5. BUSUITAN (oo (6 mg/ml) > 240
6. CarbOPIatin ......cooveriiiiiiiiiieet et (10 mg/ml) > 240
7. CarfllZOmUD.......cccoiiiiiiiee et (2 mg/ml) > 240
8. Carmusting BCINU .......ccciiiiiiiiiiiciiececcee ettt (3.3 mg/ml) 14.7 (Do not use)
9. Cetuximab (ErDituX) ....cceevieiiiiiiitieiiesee ettt ettt e (2 mg/ml) > 240
LU 170 1 | 1 PRSP (1.0 mg/ml) > 240
11. Cyclophosphamide (CYtoXan) ...........coceverirerreneninceneneseetee e (20 mg/ml) > 240
12. Cytarabine HCI (CYtOSING) ......oceiruirriieiieiieniiesiierieesie et (100 mg/ml) > 240
I3, CYLOVEIE ...ttt et sttt sttt e (10 mg/ml) > 240
14. Dacarbazine DTIC ........ccoociiiiiiiiiiiecee ettt (10 mg/ml) > 240
15. DAUNOTUDICIN «....eevviiiiieiieeiie ettt et st ene e et e e eneas (5.0 mg/ml) > 240
16. DECItADING .....eeeuiieiiieieeiieie ettt ettt ettt et e e et esaeeeneas (5 mg/ml) > 240
17, DOCEIAXEL -ttt ettt ettt ettt ettt et et et e et et e et e e neeenteens (10.0 mg/ml) > 240
18. Doxorubicin Hydrochloride .............cocooievininiiiininiiiienccceccccee (2.0 mg/ml) > 240
19. Ellence (EPirubiCin) ........ccueeouiiiirieiieiieeie ettt (2 mg/ml) > 240
20. Eribulin MESYIAE .......c.eeuieiiieieeiieiieieeie ettt ettt et e nne e (0.5 mg/ml) > 240
21. Etopside TOPOSAT .....cc.couiiiiiiiiiiiiiiniecieeee ettt (20 mg/ml) > 240
22, FIUdarabine ...........cccuoiiiiiiriiiieeie ettt st (25 mg/ml) > 240
23. Fluorouracil (5-Fluorouracil / Adrucil) .........cccceeveeviiniiniiieieceece e, (50mg/ml) > 240
24, FUIVESIIANT .....eeiniiiiieieeiteecieetee ettt ettt ettt et e ee et e eaees (50 mg/ml) > 240
25, GEMCIADING .....oovviiieiiiiiiecieccee e e e s (38.0 mg/ml) > 240
26. 1AATUDICIN .....eeiietieiiee ettt ettt et b ettt aeens (1.0 mg/ml) > 240
27, TEOSTAMIAE ...oceeeeeiiiiiece e (50.0 mg/ml) > 240
28. Irinotecan HCI ........ccooviiiieiieieeeee ettt e (20.0 mg/ml) > 240
29. Mechlorethamine HCI ...........ooccoiiiiiiiiiiiiee e (1.0 mg/ml) > 240
RO, (=] 1) o =1 1 o USRS (5 mg/ml) > 240
R LY, (=11 T () 1 USSP (25 mg/ml) > 240
32, MItOMYCIN-C oottt ettt sttt be et seeneensenseenas (0.5 mg/ml) > 240
33, MILOXANTIONE ....evveeieeeereeeieeiieeiieeieeteeeeeeeeeenteseeeeneeeneesnsesseesseesseesneesnnesnnesseesneens (2.0 mg/ml) > 240
34, OXAlIPIAtin ..ot (5§ mg/ml) > 240
35. PaclitaXel (TAXOL) ....ovoveriieiieieeeee ettt (6 mg/ml) > 240
36. PeMEtreXed ......c.oouiiiieiieiieit ettt e (25 mg/ml) > 240
37. Pertuzumab ..........cccooiiiiiiie et (30 mg/ml) > 240
38. RAIIIIEXEd ...oveeeieiieiieeeeee et (0.5 mg/ml) > 240
39. REIIOVIT ittt sttt esneesree e esneeeeas (10 mg/ml) > 240
40. RITUXIMAD ..ottt ettt ettt ettt (10 mg/ml) > 240
41. TEMSITOIIMUS ...ouviiiieiiiiie ettt e e (25 mg/ml) > 240
42. B 11 0] (< o USRS (10 mg/ml) 39.4 (Do not use)
43. Topotecan HCL ........cooiiiiiiiiiee e (1 mg/ml) > 240
44. TrastuZumab .........ocoiiiiiiee e (21 mg/ml) > 240
45. TTICIOSAN ..eeiieeeteeee ettt et et (1 mg/ml) > 240
46. Trisenox (Arsenic TrioXide) ........cceecieieeiiriiiiieieee e (1 mg/ml) > 240
47. VINDIASINE ..ottt st ettt neeas (1 mg/ml) > 240
48. ViINCriSting SUIALE .....c.ooviiiiiiiiiie e (1.0 mg/ml) > 240
49. VINOTEIDINEG ....eeiniieiieiieieeeee ettt e e nae e (10 mg/ml) > 240
50. Z,01edroniC ACIA .....covuiiiiiiiieiietieree e (0.8 mg/ml) > 240
The maximum testing time is 240 minutes. Please note that Carmustine (BCNU) (3.3 mg/ml) and Thiotepa (10 mg/ml) have extremely low permeation times and should not be used with this glove.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K211390 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211390: Nitrile Blue Powder-free Examination Glove.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211390
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026