# K182241: Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs

- Pathway: 510(k) (Abbreviated)
- Applicant: Sri Trang Gloves (Thailand) Co., Ltd.
- Decided: Mar 11, 2019 after 203 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: 4 generations back to K000323 (2000). 4 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083755: Non-Sterile, Powder Free Nitrile Examination Glove, Lavender Blue Color, Polymer Coated, Texted with Chemotherapy Drugs, Siam Sempermed Corp., Ltd. (2009) Summary page 5.

## Most influential descendants
- K200072: KIMTECH Purple Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, the Opioid Fentanyl, Gastric acid, and Fentanyl in Gastric acid (2020), 3 descendants of its own
- K193581: Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Lilac, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Orchid, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Oyster (2020), 3 descendants of its own
- K203236: Rhino Health Non-Sterile, Powder-free Nitrile Exam Glove (2021), 2 descendants of its own
- K221082: Rhino Non-Sterile, Powder-Free Nitrile Exam Gloves – Periwinkle Color Tested for Use with Chemotherapy Drugs, and Fentanyl (2022), 1 descendant of its own
- K231435: KIMTECH™ Polaris™ Xtra Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (2023), 0 descendants of its own

## Indications for use
This device is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The tested chemotherapy drugs are as follows: Carmustine (BCNU) 3.3 mg/mL Cisplatin 1.0 mg/mL Cyclophosphamide (Cytoxan) 20 mg/mL Dacarbazine (DTIC) 10.0 mg/mL Doxorubicin Hydrochloride 2.0 mg/mL Etoposide (Toposar) 20.0 mg/mL Fluorouracil 50.0 mg/mL Methotrexate 25 mg/mL Paclitaxel (Taxol) 6.0 mg/mL Thiotepa 10.0 mg/mL Vincristine Sulfate 1.0 mg/mL Note that Carmustine(BCNU) and Thiotepa have low permeation times. Fentayl tested as follows: Fentanyl citrate 100 mcg/2mL

Source page: https://510kreport.com/device/K182241
Methodology: https://510kreport.com/methodology