# K123749: Powder Free Nitrile Patient Examination Gloves, Green, Non-Sterile

- Pathway: 510(k) (Traditional)
- Applicant: Kossan Latex Industries (M)Sdn Bhd
- Decided: Mar 1, 2013 after 85 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: 2 generations back to K102790 (2010). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120066: Powder Free Nitrile Patient Examination Glove, Blue, White and Green Colored. Non-Sterile, Low Dermatitis Potential, Kossan Latex Industries (M)Sdn Bhd (2012) Summary page 1.

## Indications for use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner’s hand to prevent contamination between patient and examiner. This glove has been tested for use with specific chemotherapy drugs listed below. Dacarbazine (DTIC) (10.0 mg/ml) > 240 minutes Carmustine (BCNU) (3.3 mg/ml) 15.3 minutes Cyclophosphamide (Cytoxan) (20.0 mg/ml) > 240 minutes Doxorubicin Hydrochloride (2.0 mg/ml) > 240 minutes Fluorouracil (50.0 mg/ml) > 240 minutes Cisplatin (1.0 mg/ml) > 240 minutes Etoposide (20.0 mg/ml) > 240 minutes Paclitaxel (Taxol) (6.0 mg/ml) > 240 minutes Thiotepa (10.0 mg/ml) 195.8 minutes Please note that Carmustine has extremely low permeation times of 15.3 minutes.

Source page: https://510kreport.com/device/K123749
Methodology: https://510kreport.com/methodology