# K260867: Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black)

- Pathway: 510(k) (Special)
- Applicant: Hartalega NGC Sdn. Bhd.
- Decided: Jun 17, 2026 after 92 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 K200019 (2020). 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)
- K200019: Nitrile Powder Free Examination Gloved Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue), Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black), Hartalega NGC Sdn. Bhd. (2020) Summary page 7.

## Indications for use
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drug and Fentanyl Citrate (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 and Fentanyl Citrate. The list of Chemotherapy Drugs tested (with breakthrough time) are: Chemotherapy Drug and Concentration Minimum Breakthrough Detection Time in Minutes Carmustine (3.3 mg/ml) 20.0 Cisplatin (1.0 mg/ml) >240 Cyclophosphamide (Cytoxan) (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 (Taxol) (6.0 mg/ml) >240 Thiotepa (10.0 mg/ml) 54.0 Vincristine Sulfate (1.0 mg/ml) >240 5-Azacytidine (25.0 mg/ml) >240 Carboplatin (10.0 mg/ml) >240 Docetaxel (10 mg/ml) >240 Epirubicin (2.0 mg/mL) >240 Gemcitabine (38 mg/ml) >240 Ifosfamide (50 mg/ml) >240 Irinotecan (20 mg/ml) >240 Mitoxantrone (2.0 mg/ml) >240 Oncovin (1.0 mg/ml) >240 Oxaliplatin (5 mg/ml) >240 Vinorelbine (10 mg/ml) >240 Caution: Testing showed a minimum breakthrough time of 20.0 minutes with Carmustine and 54.0 minutes with Thiotepa. Warning: Do not use with Carmustine. Fentanyl Citrate and Concentration Minimum Breakthrough Detection Time in Minutes Fentanyl Citrate Injection (100 mcg/2ml) >240 Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drug and Fentanyl Citrate (Black) 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 and Fentanyl Citrate. The list of Chemotherapy Drugs tested (with breakthrough time) are: Chemotherapy Drug and Concentration Minimum Breakthrough Detection Time in Minutes Carmustine (3.3 mg/ml) 25.0 Cisplatin (1.0 mg/ml) >240 Cyclophosphamide (Cytoxan) (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 (Taxol) (6.0 mg/ml) >240 Thiotepa (10.0 mg/ml) 55.7 Vincristine Sulfate (1.0 mg/ml) >240 5-Azacytidine (25.0 mg/ml) >240 Carboplatin (10.0 mg/ml) >240 Docetaxel (10 mg/ml) >240 Epirubicin (2.0 mg/mL) >240 Gemcitabine (38 mg/ml) >240 Ifosfamide (50 mg/ml) >240 Irinotecan (20 mg/ml) >240 Mitoxantrone (2.0 mg/ml) >240 Oncovin (1.0 mg/ml) >240 Oxaliplatin (5 mg/ml) >240 Vinorelbine (10 mg/ml) >240 Caution: Testing showed a minimum breakthrough time of 25.0 minutes with Carmustine and 55.7 minutes with Thiotepa. Warning: Do not use with Carmustine Fentanyl Citrate and Concentration Minimum Breakthrough Detection Time in Minutes Fentanyl Citrate Injection (100 mcg/2ml) >240

Source page: https://510kreport.com/device/K260867
Methodology: https://510kreport.com/methodology