# K252117: Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid Solution

- Pathway: 510(k) (Special)
- Applicant: Sw Technologies, Inc.
- Decided: Jun 24, 2026 after 352 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
A disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. Chemotherapy Drug and Concentration Breakthrough times in minutes per ASTM D6978-05 (2019) Carmustine (BCNU), 3.3mg/ml 86.3 Cisplatin, 1.0mg/ml >240 Cyclophosphamide (Cytoxan), 20mg/ml >240 Dacarbazine (DTIC) 10g mg/ml >240 Doxorubicin Hydrochloride, 2.0 mg/ml >240 Etoposide (Toposar), 20mg/ml >240 Fluorouracil 50mg/ml >240 Paclitaxel (Taxol), 6.0mg/ml >240 Thiotepa, 10mg/ml 89.3 Bleomycin Sulfate,15 mg/ml (15,000 ppm) >240 Busulfan,6 mg/ml (6,000 ppm) >240 Carboplatin, 10 mg/ml (10,000 ppm) >240 Cytarabine, 100 mg/ml (100,000 ppm) >240 Daunorubicin HCI,5 mg/ml (5,000 ppm) >240 Docetaxel HCI, 10 mg/ml (10,000 ppm) >240 Epirubicin HCI (Ellence),2 mg/ml (2,000 ppm) >240 Fludarabine Phosphate,25 mg/ml (25,000 ppm) >240 Gemcitabine HCIL,38 mg/ml (38,000 ppm) >240 Idarubicin HCI,1 mg/ml (1,000 ppm) >240 Mechlorethamine HCI,1 mg/ml (1,000 ppm) >240 Melphalan HCL5 mg/ml (5,000 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,2 mg/ml (2,000 ppm) >240 Rituximab, 10 mg/ml (10,000 ppm) >240 Trisenox (Arsenic Trioxide), 1 mg/ml (1,000 ppm) >240 Vincristine Sulfate,1 mg/ml (1,000 ppm) >240 Vinorelbine, 10 mg/ml (10,000 ppm) >240 Ifosfamide (50.0 mg/ml) >240 Irinotecan (20.0 mg/ml) >240 Fentanyl Citrate 100mcg/2ml >240 Simulated Gastric Acid >240 Fentanyl-Simulated Gastric Acid Solution 50/50 >240 Caution: Please note low permeation times for Carmustine at 86.3 minutes and Thiotepa at §9.3 minutes.

Source page: https://510kreport.com/device/K252117
Methodology: https://510kreport.com/methodology