# K212639: Disposable Medical Nitrile Examination Gloves (Non sterile)

- Pathway: 510(k) (Traditional)
- Applicant: Jiangsu Nanfang Medical Co., Ltd.
- Decided: Dec 8, 2021 after 110 days
- Product code: LZC (Medical Glove, Specialty)
- 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: 5 generations back to K042805 (2004). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172525: Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, Central Medicare Sdn Bhd (2017) Summary page 4.

## Indications for use
Disposable Medical Nitrile Examination Gloves (Non sterile) are a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, these patient examination gloves were tested for use with the following drug concentrations per ASTM D6978-05(2019): The following drugs had NO breakthrough detected up to 240 minutes: Busulfan, Fluorouracil, 6 mg/ml (6,000 ppm) 50.0 mg/ml (50,000 ppm) Carboplatin /Paraplatin, lfosfamide, 10 mg/ml (10,000 ppm) 50 mg/ml (50,000 ppm) Cisplatin, Mechlorethamine HCI, 1.0 mg/ml (1,000 ppm) 1 mg/ml (1,000 ppm) Cyclophosphamide (Cytoxan), Methotrexate, 20.0 mg/ml (20,000 ppm) 25 mg/ml (25,000 ppm) Cytarabine HCI, Mitomycin, 100 mg/ml (100,000 ppm) 0.5 mg/ml (500 ppm) Dacarbazine, Mitoxantrone, 10.0 mg/ml (10,000 ppm) 2 mg/ml (2,000 ppm) Docetaxel, Paclitaxel, 10 mg/ml (10,000 ppm) 6.0 mg/ml (6,000 ppm) Doxorubicin HCI, Vincristine Sulfate, 2.0 mg/ml (2,000 ppm) 1 mg/ml (1,000 ppm) Etoposide, 20.0 mg/ml (20,000 ppm) Please note that the following drug has low permeation times of less than 60 minutes: Carmustine (BCNU) 3.3 mg/ml (3,300 ppm), 44.7minutes ThioTepa10.0 mg/ml (10,000 ppm),35.7 minutes WARNING: Do not use Carmustine and Thiotepa

Source page: https://510kreport.com/device/K212639
Methodology: https://510kreport.com/methodology