# K232064: Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with Chemotherapy Drugs and Fentanyl Citrate)

- Pathway: 510(k) (Traditional)
- Applicant: Isikel Manufacturing, LLC
- Decided: Oct 2, 2023 after 83 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
Longest line of descent: 4 generations back to K082957 (2009). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211810: Shamrock Powder Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl), Pt. Shamrock Manufacturing Corpora (2022) Summary page 5.

## Indications for use
Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with Chemotherapy Drugs and Fentanyl Citrate) is a disposable device intended for medical purposes that is worn on the examiner’s hands to prevent contamination between patient and examiner. In addition, these gloves were tested for use with Chemotherapy drugs and Fentanyl Citrate in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to permeation by Chemotherapy Drugs. Chemotherapy Drug Concentration Breakthrough Detection Time Carmustine 3.3 mg/ml (3,300 ppm) 16.2 (16.2,21.6,21.9) min. Cisplatin 1 mg/ml (1,000 ppm) >240 min. Cyclophosphamide 20 mg/ml (20,000 ppm) >240 min. Dacarbazine 10 mg/ml (10,000 ppm) >240 min. Doxorubicin HCL 2 mg/ml (2,000 ppm) >240 min. Etoposide 20 mg/ml (20,000 ppm) >240 min. Fluorouracil 50 mg/ml (50,000 ppm) >240 min. Mitomycin C 0.5 mg/ml (500 ppm) >240 min. Paclitaxel 60 mg/ml (6,000 ppm) >240 min. Thiotepa 10 mg/ml (10,000 ppm) 40.6 (70.6,40.6,40.6) min. Vincristine Sulfate 1 mg/ml (1,000 ppm) >240 min. Fentanyl/Citrate Injection 100 mcg/2mL >240min. Please note the following drugs have low permeation times: Carmustine 3.3 mg/ml (3,300 ppm) 16.2 minutes Thiotepa 10 mg/ml (10,000 ppm) 40.6 minutes Warning: Do Not Use with Carmustine and Thiotepa

Source page: https://510kreport.com/device/K232064
Methodology: https://510kreport.com/methodology