# K230662: Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, And Select Other Drugs

- Pathway: 510(k) (Traditional)
- Applicant: Zhonghong Pulin Medical Products Co., Ltd.
- Decided: Oct 26, 2023 after 230 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.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193555: Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate, Ever Global (Vietnam) Enterprise Corp (2020) Summary page 7.

## Indications for use
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs, Fentanyl Citrate, and select other drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs. Chemotherapy Drug — Concentration — Breakthrough Detection Time (minutes) Bendamustine HCI — 5 mg/ml (5,000 ppm) — > 240 Bleomycin Sulfate — 15 mg/ml (15,000 ppm) — > 240 Busulfan — 6 mg/ml(6,000 ppm) — > 240 Carboplatin — 10.0 mg/ml (10,000 ppm) — > 240 Carfilzomib — 2 mg/ml (2,000 ppm) — > 240 Carmustine — 3.3 mg/ml (3,300 ppm) — 21.1 (24.2,21.1,25.3) Cetuximab — 2 mg/ml (2,000 ppm) — > 240 Cisplatin — 1 mg/ml (1000 ppm) — > 240 Cladribine — 1 mg/ml (1000 ppm) — > 240 Cyclophosphamide — 20 mg/ml (20.000 ppm) — > 240 Cytarabine(Cytosine) — 10 mg/ml(10,000 ppm) — > 240 Cytovene(Ganciclovir) — 10 mg/ml(10,000 ppm) — > 240 Dacarbazine — 10 mg/ml(10,000 ppm) — > 240 Daunorubicin HCI — 5 mg/ml (5,000 ppm) — > 240 Decitabine — 5 mg/ml(5,000 ppm) — > 240 Docetaxel — 10 mg/ml (10.000 ppm) — > 240 Doxorubicin HCI — 2 mg/ml (2,000 ppm) — > 240 Epirubicin HCI (Ellence) — 20 mg/ml (20,000 ppm) — > 240 Etoposide — 20 mg/ml (20,000 ppm) — > 240 Fludarabine — 25.0 mg/ml (25,000 ppm) — > 240 Fluorouracil — 50 mg/ml,(50,000 ppm) — > 240 Fulvestrant — 50 mg/ml(50,000 ppm) — > 240 Gemcitabine — 38 mg/ml (38,000 ppm) — > 240 Idarubicin HCL — 1.0 mg/ml (1,000 ppm) — > 240 Ifosfamide — 50 mg/ml (50,000 ppm) — > 240 Irinotecan HCI — 20 mg/ml (20,000 ppm) — > 240 Mechlorethamine HCI — 1 mg/ml(1,000 ppm) — > 240 Melphalan — 5 mg/ml(5000 ppm) — > 240 Methotrexate — 25 mg/ml (25,000 ppm) — > 240 Mitomycin C — 0.5 mg/ml (500 ppm) — > 240 Mitoxantrone HCL — 2 mg/ml (2,000 ppm) — > 240 Oxaliplatin — 5 mg/ml (5,000 ppm) — > 240 Paclitaxel — 6 mg/ml (6,000 ppm) — > 240 Paraplatin — 10 mg/ml (10,000 ppm) — > 240 Pemetrexed — 25 mg/ml (25,000 ppm) — > 240 Raltitrexed — 0.5 mg/ml (500 ppm) — > 240 Rituximab — 10 mg/mi (10,000 ppm) — > 240 Temsirolimus — 25 mg/ml (25,000 ppm) — > 240 Thiotepa — 10 mg/ml(10,000 ppm) — 74.9 (74.9, 96.7, 79.0) Topotecan — 1 mg/ml (1,000 ppm) — > 240 Trisenox (Arsenic Trioxide) — 1 mg/ml (1,000 ppm) — > 240 Vinblastine, — 1 mg/ml (1,000 ppm) — > 240 Vincristine sulfate (Oncovin) — 1 g/ml (1,000 ppm) — > 240 Vinorelbine — 10 mg/ml(10,000 ppm) — > 240 Fentanyl Citrate and other Drugs — Concentration — Breakthrough Detection Time (minutes) Chloroquine — 50 mg/m (50,000 ppm) — > 240 Cyclosporin A — 100.0 mg/ml (100,000 ppm) — > 240 MESNA — 100 mg/ml(100,000 ppm) — > 240 Retrovir — 10 mg/ml(10,000 ppm) — > 240 Triclosan — 3 mg/ml(3,000 ppm) — > 240 Zoledronic Acid — 1 mg/25ml (40 ppm) — > 240 Fentanyl Citrate Injection — 100mcg/2mL — > 240 Note: The maximum testing time is 240 minutes. And testing showed minimum breakthrough time of 21.1 minutes with Carmustine (3.3 mg/ml), 74.9 minutes with Thio Tepa (10 mg/ml). Warning: Do not use with Carmustine and Thiotepa.

Source page: https://510kreport.com/device/K230662
Methodology: https://510kreport.com/methodology