# K183441: Powder-free Nitrile Patient Examination Glove, Green Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs

- Pathway: 510(k) (Traditional)
- Applicant: Semperit Investments Asia Pte, Ltd.
- Decided: Oct 4, 2019 after 296 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 K090412 (2009). 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)
- K151824: Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs, Powder Free Nitrile Patient Examination Glove, White Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs, Kossan International Sdn Bhd (2016) Summary page 4.

## Indications for use
This device is an ambidextrous patient examination glove that is non-sterile, single use, disposable device intended for medical purposes, worn on the examiner's hand to prevent contamination between patient and examiner. The glove was tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs listed below Minimum Breakthrough detection time (minutes) Carmustine (BCNU) (3.3 mg/ml) 15.9 Cisplatin (1.0 mg/ml) >240 Cyclophosphamide (Cytoxan) (20.0 mg/ml) >240 Cytarabine (100mg/ml) >240 Dacarbazine (DTIC) (10.0 mg/ml) >240 Doxorubicin Hydrochloride (2.0 mg/ml) >240 Etoposide (20.0 mg/ml) >240 Fluorouracil (50.0 mg/ml) >240 Ifosfamide (50.0 mg/ml) >240 Methotrexate (25.0 mg/ml) >240 Mitomycin C (0.5 mg/ml) >240 Mitoxantrone (2.0 mg/ml) >240 Paclitaxel (Taxol) (6.0 mg/ml) >240 Thiotepa (10.0 mg/ml) 11.1 Vincristine Sulfate (1.0 mg/ml) >240 Do not use with Carmustine and Thiotepa. Please note that the following drugs have extremely low permeation times: Carmustine (BCNU): 15.9 minutes and Thiotepa:11.1 minutes.

Source page: https://510kreport.com/device/K183441
Methodology: https://510kreport.com/methodology