# K232538: Dual Color Nitrile Examination Gloves, Powder Free, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl

- Pathway: 510(k) (Traditional)
- Applicant: Wrp Asia Pacific Sdn. Bhd.
- Decided: Nov 17, 2023 after 87 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 K042805 (2004). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161422: Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs, Wrp Asia Pacific Sdn. Bhd. (2016) Summary page 6.

## 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. These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs: Chemotherapy Drug Concentration Average Breakthrough Detection Time (Minutes) *Carmustine (BCNU) (3.3 mg/ml) 44.5 Cisplatin (1.0 mg/ml) > 240 Cyclophosphamide (Cytoxan) (20.0 mg/ml) > 240 Dacarbazine (10.0 mg/ml) > 240 Doxorubicin Hydrochloride (2.0 mg/ml) > 240 Etoposide (20.0 mg/ml) > 240 Fluorouracil (50.0 mg/ml) > 240 Ifosfamide (50.0 mg/ml) > 240 Methotrexate (25.0 mg/ml) > 240 Mitomycin C (0.5 mg/ml) > 240 Mitoxantrone (2.0 mg/ml) > 240 Paclitaxel (6.0 mg/ml) > 240 *ThioTepa (10.0 mg/ml) 79.1 Vincristine Sulfate (1.0 mg/ml) > 240 *WARNING: Please note the following drugs have extremely low permeation times: Carmustine (BCNU): 44.5 minutes and Thiotepa: 79.1 minutes. Do not use with Carmustine and Thiotepa. Opioid Drug Breakthrough Detection Time in Minutes Fentanyl Citrate Injection (50 mcg/ml) No breakthrough up to 240 minutes

Source page: https://510kreport.com/device/K232538
Methodology: https://510kreport.com/methodology