# K231740: MemorialTM Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Us Glove Supply
- Decided: Jul 4, 2023 after 20 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: 5 generations back to K042805 (2004). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172525: Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, Central Medicare Sdn Bhd (2017) Summary page 5.

## Indications for use
These Powder Free, Nitrile Examination Gloves are a disposable device intended for medical purpose that is worn on the examiner's hands to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. Chemotherapy Drug Permeation The following chemicals have been tested with these gloves: Tested Chemotherapy Drug and Concentration Minimum Breakthrough Detection time Cyclophosphamide (20.0 mg/ml) No breakthrough for up to 240 minutes Doxorubicin Hydrochloride (2.0 mg/ml) No breakthrough for up to 240 minutes Etoposide (20.0 mg/ml) No breakthrough for up to 240 minutes 5-Fluorouracil (50.0 mg/ml) No breakthrough for up to 240 minutes Paclitaxel (Taxol) (6.0 mg/ml) No breakthrough for up to 240 minutes Cisplatin (1.0 mg/ml) No breakthrough for up to 240 minutes Dacarbazine (10.0 mg/ml) No breakthrough for up to 240 minutes Methotrexate (25 mg/ml) No breakthrough for up to 240 minutes Mitomycin C (0.5 mg/ml) No breakthrough for up to 240 minutes Vincristine Sulfate (1.0 mg/ml) No breakthrough for up to 240 minutes Carmustine (BCNU) (3 .3 mg/ml) Min minutes before breakthrough =14.9 Thio-Tepa (10.0 mg/ml) Min minutes before breakthrough =37.8 Waming Not For use with Carmustine Waming Not For use with Thio-Tepa *Please note that the following drugs have low permeation times: Carmustine (BCNU): 14.9 Minutes and Thio-Tepa: 37.8 Minutes

Source page: https://510kreport.com/device/K231740
Methodology: https://510kreport.com/methodology