# K211390: Nitrile Blue Powder-free Examination Glove

- Pathway: 510(k) (Traditional)
- Applicant: Cardinal Health200, LLC
- Decided: Aug 28, 2021 after 115 days
- Product code: LZA (Polymer Patient Examination Glove)
- Device class: 1
- Regulation: 21 CFR 880.6250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
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.

Source page: https://510kreport.com/device/K211390
Methodology: https://510kreport.com/methodology