# K092327: Micro-Touch Nitra Free

- Pathway: 510(k) (Abbreviated)
- Applicant: Ansell Healthcare Products, LLC
- Decided: Sep 21, 2009 after 48 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
This is a medical glove to be worn on the hands of health care and similar personnel to prevent contamination between health care personnel and the patient's body, fluids, waste or environment, and tested for use with chemotherapy drugs. Chemotherapy Drug Permeation (average breakthrough detection time in minutes) (ASTM D6978-05) *Carmustine 45.27 Cyclophosphamide >240 Doxorubicin Hydrochloride >240' Etoposide (Toposar) >240 5-Fluorouracil >240 Paclitaxel (Toxol) >240 Thio-Tepa 93.50 Vincristme Sulfate >240 Methotrexate >240 *Caution: Testing showed an average breakthrough time of 45 minutes with Carmustine.

Source page: https://510kreport.com/device/K092327
Methodology: https://510kreport.com/methodology