# K151343: Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (white, blue, orange)

- Pathway: 510(k) (Traditional)
- Applicant: Hartalega NGC Sdn. Bhd.
- Decided: Aug 24, 2015 after 97 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 Gloves Tested for Use with Chemotherapy Drugs (Blue) is 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 33 0.1 Cisplatin 1.0 >240 Cyclophosphamide (Cytoxan) 20.0 >240 Dacarbazine 10.0 >240 Doxorubixin Hydrochloride 2.0 >240 Etoposide 20.0 >240 Fluoroucil 50.0 >240 Methotrexate 25.0 >240 Mitomycin 0.5 >240 Paclitaxel 6.0 >240 Thiotepa 10.0 20.4 Vincristine Sulfate 1.0 >240 Please note the following drugs Carmustine and Thiotepa have extremely low permeation times of 0.1 and 20.4 minutes respectively. The Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (Orange) is 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 33 20.3 Cisplatin 1.0 >240 Cyclophosphamide (Cytoxan) 20.0 >240 Dacarbazine 10.0 >240 Doxorubixin Hydrochloride 2.0 >240 Etoposide 20.0 >240 Fluoroucil 50.0 >240 Methotrexate 25.0 >240 Mitomycin 0.5 >240 Paclitaxel 6.0 >240 Thiotepa 10.0 50.6 Vincristine Sulfate 1.0 >240 Please note the following drugs Carmustine and Thiotepa have extremely low permeation times of 20.3 and 50.6 minutes respectively. The Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (White) is 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 33 20.4 Cisplatin 1.0 >240 Cyclophosphamide (Cytoxan) 20.0 >240 Dacarbazine 10.0 >240 Doxorubixin Hydrochloride 2.0 >240 Etoposide 20.0 >240 Fluoroucil 50.0 >240 Methotrexate 25.0 >240 Mitomycin 0.5 >240 Paclitaxel 6.0 >240 Thiotepa 10.0 71.0 Vincristine Sulfate 1.0 >240 Please note the following drugs Carmustine and Thiotepa have extremely low permeation times of 20.4 and 71.0 minutes respectively.

Source page: https://510kreport.com/device/K151343
Methodology: https://510kreport.com/methodology