# 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

- Pathway: 510(k) (Traditional)
- Applicant: Hartalega NGC Sdn. Bhd.
- Decided: Feb 6, 2017 after 111 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- 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 (2026), 0 descendants of its own

## Indications for use
The Nitrile Powder Free Examination Glove 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 times) are; Chemotherapy Drugs Concentration (mg/ml) Breakthrough time (minutes) Carmustine (BCNU) 3.3 10.3 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 28.8 Vincristine Sulfate 1.0 >240 Please note the following drugs Carmustine and Thiotepa have extremely low permeation times of 10.3 and 28.8 minutes respectively. The Nitrile Powder Free Examination Glove 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 times) are; Chemotherapy Drugs Concentration (mg/ml) Breakthrough time (minutes) Carmustine (BCNU) 3.3 10.2 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 30.2 Vincristine Sulfate 1.0 >240 Please note the following drugs Carmustine and Thiotepa have extremely low permeation times of 10.2 and 30.2 minutes respectively. The Nitrile Powder Free Examination Glove 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 times) are; Chemotherapy Drugs Concentration (mg/ml) Breakthrough time (minutes) Carmustine (BCNU) 3.3 7.3 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 20.6 Vincristine Sulfate 1.0 >240 Please note the following drugs Carmustine and Thiotepa have extremely low permeation times of 7.3 and 20.6 minutes respectively. The Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs - Dark 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 times) are; Chemotherapy Drugs Concentration (mg/ml) Breakthrough time (minutes) Carmustine (BCNU) 3.3 0.2 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 0.5 >240 Paclitaxel 6.0 >240 Thiotepa 10.0 10.3 Vincristine Sulfate 1.0 >240 Please note the following drugs Carmustine and Thiotepa have extremely low permeation times of 0.2 and 10.3 minutes respectively.

Source page: https://510kreport.com/device/K162923
Methodology: https://510kreport.com/methodology