# K093523: Micro-Touch Nitrile

- Pathway: 510(k) (Abbreviated)
- Applicant: Ansell Healthcare Products, LLC
- Decided: Mar 4, 2010 after 111 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 K031580 (2003). 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)
- K031580: Non-Sterile, Powder-Free, Blue Color Nitrile Examination Glove, Green Prospect Sdn Bhd (2003) Summary page 1.

## 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) *Car.mustine 12.4 Cyclophosphamide >240 Doxorubicin Hydrochloride >240 Etoposide (Toposar) >240 5-Fluorouracil >240 Paclitaxel (Toxol) >240 *ThioTEPA 19.6 Cisplatin >240 Dacarbazine >240 *WARN4ING: Do not use with Carmustine or ThioTEPA.

Source page: https://510kreport.com/device/K093523
Methodology: https://510kreport.com/methodology