# K210944: Powder Free Nitrile Examination Glove, Tested for Use with Chemoterapy Drugs (Blue)

- Pathway: 510(k) (Traditional)
- Applicant: Harbour Health, LLC
- Decided: Apr 29, 2021 after 30 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: 7 generations back to K042805 (2004). 8 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182600: Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue), Better Care Plastic Technology Co., Ltd. (2018)

## Most influential descendants
- K213227: Powder free Nitrile Examination Glove-(Test for use with Chemotherapy Drugs) (2022), 1 descendant of its own
- K221350: Non-Sterile Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) (2022), 0 descendants of its own
- K213076: AspenMed+ (2021), 0 descendants of its own
- K212898: Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With Chemotherapy Drugs (2021), 0 descendants of its own
- K212827: Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs (2021), 0 descendants of its own

## Indications for use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. Chemotherapy Drug Permeation: No. Chemotherapy Drug Tested Concentration Breakthrough Detection Time (Minutes) 1 Busulfan 6 mg/ml (6,000 ppm) > 240 2 Carboplatin 10 mg/ml (10,000 ppm) > 240 3 Carmustine (BCNU) 3.3 mg/ml (3,300 ppm) 14.5* 4 Cisplatin 1.0 mg/ml (1,000 ppm) > 240 5 Cyclophosphamide (Cytoxan) 20.0 mg/ml (20,000 ppm) > 240 6 Cytarabine 100 mg/ml (100,000 ppm) > 240 7 Dacarbazine 10.0 mg/ml (10,000 ppm) > 240 8 Docetaxel 10 mg/ml (10,000 ppm) > 240 9 Doxorubicin HCI 2.0 mg/ml (2,000 ppm) > 240 10 Etoposide 20.0 mg/ml (20,000 ppm) > 240 11 Fluorouracil 50.0 mg/ml (50,000 ppm) > 240 12 Ifosfamide 50 mg/ml (50,000 ppm) > 240 13 Mechlorethamine HCI 1 mg/ml (1,000 ppm) > 240 14 Methotrexate 25 mg/ml (25,000 ppm) > 240 15 Mitomycin C 0.5 mg/ml (500 ppm) > 240 16 Mitoxantrone 2 mg/ml (2,000 ppm) > 240 17 Paclitaxel 6.0 mg/ml (6,000 ppm) > 240 18 Thiotepa 10.0 mg/ml (10,000 ppm) 47.4* 19 Vincristine Sulfate 1.0 mg/ml (1,000 ppm) > 240 *WARNING: Not recommended for use with Carmustine and Thiotepa. The maximum testing time is 240 minutes. Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml (3,300 ppm) 14.5 minutes Thiotepa 10.0 mg/ml (10,000 ppm) 47.4 minutes

Source page: https://510kreport.com/device/K210944
Methodology: https://510kreport.com/methodology