# K210330: Powder Free Black Nitrile Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant

- Pathway: 510(k) (Traditional)
- Applicant: Wrp Asia Pacific Sdn. Bhd.
- Decided: Mar 4, 2022 after 393 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: 1 generation back to K183287 (2019). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183287: Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Kossan International Sdn Bhd (2019) Summary page 4.

## 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 per ASTM D6978-05 (Re-approved 2013) Standard Practice for assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Chemotherapy Drug Breakthrough Detection Time in Minutes *Carmustine (BCNU) 21.2 Cisplatin > 240 Cyclophosphamide (Cytoxan) > 240 Dacarbazine > 240 Doxorubicin Hydrochloride > 240 Etoposide > 240 Fluorouracil > 240 Ifosfamide > 240 Methotraxate > 240 Mitomycin C > 240 Mitoxantrone > 240 Paclitaxel > 240 *Thiotepa 34.6 Vincristine Sulfate > 240 *WARNING: Please note the following drugs have extremely low permeation times: Carmustine (BCNU): 21.1 minutes and Thiotepa: 34.6. Do not use with Carmustine and Thiotepa. Fentanyl Resistance Breakthrough Detection Time in Minutes Fentanyl Citrate Injection No breakthrough up to 240 minutes

Source page: https://510kreport.com/device/K210330
Methodology: https://510kreport.com/methodology