# K231643: Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)

- Pathway: 510(k) (Traditional)
- Applicant: Syntex Healthcare Products Co., Ltd.
- Decided: Sep 8, 2023 after 95 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 K200581 (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)
- K200581: Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue), Hartalega NGC Sdn. Bhd. (2020) Summary page 5.

## Indications for use
The 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 and Fentanyl Citrate using ASTM D6978-05(2019) Chemotherapy Drug Minimum BDT (Minutes) Azacytidine (Vidaza) 25 mg/ml (25000ppm) >240 Bleomycin Sulfate 15mg/ml (15000 ppm) >240 Busulfan 6mg/ml (6,000 ppm) >240 Carboplatin 10mg/ml (10,000 ppm) >240 Carmustine (BCNU)3.3 mg/ml (3,300 ppm) 12.9 Chloroquine 50mg/ml (50,000ppm) >240 Cisplatin 1mg/ml (1,000 ppm) >240 Cyclophosphamide 20mg/ml (20,000 ppm) >240 Cyclosporin A 100 mg/ml (100,000 ppm) >240 Cytarabine HCL, 100 mg/ml (100,000 ppm) >240 Dacarbazine 10 mg/ml (10,000 ppm) >240 Daunorubicin HCL, 5 mg/ml (5,000 ppm) >240 Docetaxel, 10 mg/ml (10,000 ppm) >240 Doxorubicin HCL, 2 mg/ml (2,000 ppm) >240 Etoposide, 20 mg/ml (20,000 ppm) >240 Epirubicin HCL, 2 mg/ml (2,000 ppm) >240 Fludarabine, 25 mg/ml (25,000 ppm) >240 Fluorouracil, 50mg/ml (50,000ppm) >240 Gemcitabine, 38mg/ml (38,000ppm) >240 Idarubicin HCL, Img/ml (1,000ppm) >240 Ifosfamide, 50mg/ml (50,000ppm) >240 Irinotecan, 20mg/ml (20,000ppm) >240 Mechlorethamine HCI, 1mg/ml (1,000ppm) >240 Melphalan, Smg/ml (5,000ppm) >240 Methotrexate, 25mg/ml (25,000ppm) >240 Mitomycin C, 0.5mg/ml (500ppm) >240 Mitoxantrone HCL, 2mg/ml (2,000ppm) >240 Oxaliplatin, Smg/ml (5,000ppm) >240 Paclitaxel, 6mg/ml (6,000ppm) >240 Paraplatin, 10mg/ml (10,000ppm) >240 Retrovir, 10mg/ml (10,000ppm) >240 Rituximab, 10mg/ml (10,000ppm) >240 Thio Tepa, 10mg/ml (10,000ppm) 35.6 Topotecan, 1mg/ml (1,000ppm) >240 Trisenox, 1mg/ml (1,000ppm) >240 Velcade (Bortezomib), 1mg/ml (1,000ppm) >240 Vincristine Sulfate (Oncovin), 1mg/ml (1,000ppm) >240 Vinorelbine, 10 mg/ml (10000ppm) >240 Fentanyl Citrate Minimum BD'T Minutes Fentanyl Citrate Injection (100 mcg/2ml) >240 *Please note that the following drugs have extremely low permeation times: Carmustine: 12.9 minutes, Thio Tepa: 35.6 minutes Warning: Do not use with Carmustine and Thio Tepa.

Source page: https://510kreport.com/device/K231643
Methodology: https://510kreport.com/methodology