# K254285: Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Aqua Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Violet Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Dark Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Dark Violet Blue

- Pathway: 510(k) (Special)
- Applicant: Hartalega NGC Sdn. Bhd.
- Decided: Jul 20, 2026 after 201 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: 1 generation back to K162923 (2017). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162923: Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs - Aqua Blue; Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs - Violet Blue; Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs - Dark Blue; Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs - Dark Violet Blue, Hartalega NGC Sdn. Bhd. (2017) Summary page 7.

## Indications for use
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Aqua Blue 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 time) are: Chemotherapy Drug and Concentration Minimum Breakthrough Detection Time Minutes Carmustine (3.3 mg/ml) 10.3 Cisplatin (1.0 mg/ml) >240 Cyclophosphamide (20.0 mg/ml) >240 Dacarbazine (10.0 mg/ml) >240 Doxorubicin Hydrochloride (2.0 mg/ml) >240 Etoposide(Toposar)(20.0 mg/ml) >240 Fluorouracil (50.0 mg/ml) >240 Methotrexate (25.0 mg/ml) >240 Mitomycin C (0.5 mg/ml) >240 Paclitaxel (6.0 mg/ml) >240 Thiotepa (10.0 mg/ml) 28.8 Vincristine Sulfate (1.0 mg/ml) >240 Caution: Testing showed a minimum breakthrough time of 10.3 minutes with Carmustine and 28.8 minutes with Thiotepa. Warning: Do not use with Carmustine and Thiotepa. Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Violet Blue 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 time) are: Chemotherapy Drug and Concentration Minimum Breakthrough Detection Time Minutes Carmustine (3.3 mg/ml) 10.2 Cisplatin (1.0 mg/ml) >240 Cyclophosphamide (20.0 mg/ml) >240 Dacarbazine (10.0 mg/ml) >240 Doxorubicin Hydrochloride (2.0 mg/ml) >240 Etoposide(Toposar)(20.0 mg/ml) >240 Fluorouracil (50.0 mg/ml) >240 Methotrexate (25.0 mg/ml) >240 Mitomycin C (0.5 mg/ml) >240 Paclitaxel (6.0 mg/ml) >240 Thiotepa (10.0 mg/ml) 30.2 Vincristine Sulfate (1.0 mg/ml) >240 Caution: Testing showed a minimum breakthrough time of 10.2 minutes with Carmustine and 30.2 minutes with Thiotepa. Warning: Do not use with Carmustine and Thiotepa. Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Dark Blue 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 time) are: Chemotherapy Drug and Concentration Minimum Breakthrough Detection Time Minutes Carmustine (3.3 mg/ml) 7.3 Cisplatin (1.0 mg/ml) >240 Cyclophosphamide (20.0 mg/ml) >240 Dacarbazine (10.0 mg/ml) >240 Doxorubicin Hydrochloride (2.0 mg/ml) >240 Etoposide(Toposar)(20.0 mg/ml) >240 Fluorouracil (50.0 mg/ml) >240 Methotrexate (25.0 mg/ml) >240 Mitomycin C (0.5 mg/ml) >240 Paclitaxel (6.0 mg/ml) >240 Thiotepa (10.0 mg/ml) 20.6 Vincristine Sulfate (1.0 mg/ml) >240 Caution: Testing showed a minimum breakthrough time of 7.3 minutes with Carmustine and 20.6 minutes with Thiotepa. Warning: Do not use with Carmustine and Thiotepa.

Source page: https://510kreport.com/device/K254285
Methodology: https://510kreport.com/methodology