# K160560: Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue)

- Pathway: 510(k) (Traditional)
- Applicant: Hartalega Sdn Bhd
- Decided: Aug 4, 2016 after 157 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Nitrile Powder Free Examination Glove with Low Dermatitis Claim and Tested for Use with Chemotherapy Drugs (Blue) is a non- sterile disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs. The list of Chemotherapy Drugs (tested with breakthrough times) as per attached table. The list of Chemotherapy Drugs tested (with breakthrough times) is as per below: Carmustine {BCNU) (3.3 mg/ml) 10.1 minutes Cisplatin (1.0 mg/ml) > 240 minutes Cyclophosphamide (Cytoxan) (20 mg/ml) > 240 minutes Dacarbazine (DTIC) (10.0 mg/ml) > 240 minutes Doxorubicin Hydrochloride (2.0 mg/ml) > 240 minutes Etoposide (Toposar) (20.0 mg/ml) > 240 minutes Fluorouracil (50.0 mg/ml) > 240 minutes Methotrexate (25 mg/ml) > 240 minutes Mitomycin C (0.5 mg/ml) > 240 minutes Paclitaxel (Taxol) (6.0 mg/ml) > 240 minutes Thiotepa (10.0 mg/ml) 20.3 minutes Vincristine Sulfate (1.0 mg/ml) > 240 minutes * Please note that the following drugs have extremely low permeation times of 10.1 minutes with Carmustine (3.3 mg/ml) and 20.3 minutes with Thiotepa (10.0 mg/ml).

Source page: https://510kreport.com/device/K160560
Methodology: https://510kreport.com/methodology