# K220088: Powder Free Nitrile Examination Glove, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

- Pathway: 510(k) (Traditional)
- Applicant: Professional Latex Sdn Bhd
- Decided: Mar 30, 2023 after 443 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: 2 generations back to K183287 (2019). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192954: Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Comfort Rubber Gloves Industries Sdn. Bhd. (2020) Summary page 5.

## Most influential descendants
- K240021: Powder Free Nitrile Examination Glove 3.5, Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (2024), 0 descendants of its own

## Indications for use
Powder Free Nitrile Examination Gloves, Non-Sterile, and tested for Use with Chemotherapy Drugs and Fentanyl Citrate is a patient medical exam gloves which is disposable device intended for medical purpose that is worn on the examiner’s hand or finger to prevent contamination between examiner and patient. The glove was 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. Tested Chemotherapy Drugs and Concentration: Cisplatin, 1.0 mg/ml > 240 Cyciophosphamide (Cytoxan), 20.0 mg/ml > 240 Dacarbazine, 10.0 mg/ml > 240 Doxorubicin HCI, 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 Vincristine Sulfate, 1.0 mg/ml > 240 Carmustine (BCNU), 3.3 mg/ml 24.3 ThioTepa, 10.0 mg/ml 48.6 Fentanyl Citrate Injection 100.0 mcg/2ml > 240 WARNING. Please note that the following drugs have extremely low permeation time: Carmustine (BCNU), 3.3 mg/ml : 24.3 minutes and Thiotepa, 10.0 mg/ml : 48.6 minutes Do not use with Carmustine and Thiotepa

Source page: https://510kreport.com/device/K220088
Methodology: https://510kreport.com/methodology