# K170794: Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (White)

- Pathway: 510(k) (Traditional)
- Applicant: Hartalega NGC Sdn. Bhd.
- Decided: Jun 30, 2017 after 106 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
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (White) is a non-sterile disposable device intended for medical purpose that is worn on the 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) are; Chemotherapy Drugs Concentration (mg/ml) Breakthrough time (minutes) Carmustine (BCNU) 3.3 Tict Cisplatin 1.0 >240 Cyclophosphamide (Cytoxan) 20.0 >240 Dacarbazine 10.0 >240 Doxorubixin Hydrochloride 2.0 >240 Etoposide (Toposar) 20.0 >240 Fluorouracil 50.0 >240 Methotrexate 25.0 >240 Mitomycin C 0.5 >240 Paclitaxel (Taxol) 6.0 >240 Thiotepa 10.0 344 Vincristine Sulfate 1.0 >240 Please note the following drugs Carmustine and Thiotepa have extremely low permeation times of 11.7 and 34.4 minutes respectively.

Source page: https://510kreport.com/device/K170794
Methodology: https://510kreport.com/methodology