# K161473: Medline Powder-Free Nitrile Exam Glove Extended Cuff (Tested for Use with Chemotherapy Dr)

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: Oct 19, 2016 after 145 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: 3 generations back to K022765 (2002). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141623: Emg Blue Nitrile Medical Examination Glove with Chemotherapy Drug Labeling Claim, Eco Medi Glove Sdn. Bhd. (2014) Summary page 4.

## Indications for use
A powder-free 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. In addition these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. The following chemicals have been tested with these gloves. Chemotherapy Drug Permeation (Breakthrough Detection Time) in Minutes Carmustine 3.3mg/ml - 40.4 min. Cisplatin 1.0mg/ml - No breakthrough up to 240 min. Cyclophosphamide 20.0mg.ml - No breakthrough up to 240 min. Dacarbazine 2.0mg/ml - No breakthrough up to 240 min. Doxorubicin Hydrochloride 2/0mg.ml - No breakthrough up to 240 min. Etoposide 20.0mg/ml - No breakthrough up to 240 min. Fluoruouracil 50mg/ml - No breakthrough up to 240 min. Methotrexate 25mg - No breakthrough up to 240 min. Mitoxantrone 2.0mg/ml - No breakthrough up to 240 min. Paclitaxel 5.0mg/ml - No breakthrough up to 240 min. Thiotepa 10mg/ml - 60.6 min. Please note that the following drugs have extremely low permeation times: Carmustine (3.3 mg/ml) has a minimum breakthrough time of 40.4 minutes; Thiotepa (10.0 mg/ml) has a minimum breakthrough time of 60.6 minutes.

Source page: https://510kreport.com/device/K161473
Methodology: https://510kreport.com/methodology