# 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

- Pathway: 510(k) (Abbreviated)
- Applicant: Sri Trang Gloves (Thailand) Public Company Limited
- Decided: Mar 20, 2020 after 88 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: 5 generations back to K000323 (2000). 5 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182241: Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs, Sri Trang Gloves (Thailand) Co., Ltd. (2019) Summary page 4.

## Most influential descendants
- 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
- K223859: Rhino Non-sterile Powder-Free Nitrile Exam Glove – Periwinkle Color Tested for Use with Chemotherapy Drugs and Fentanyl (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 and permeation times are as follows: Bleomycin Sulfate 15 mg/mL, >240 minutes Ifosfamide 50 mg/mL, >240 minutes Busulfan 6 mg/mL, >240 minutes Irinotecan 20 mg/mL, >240 minutes Carboplatin (Paraplatin) 10 mg/mL, >240 minutes Mechlorethamine 1 mg/mL, >240 minutes Carmustine (BCNU) 3.3 mg/mL, 17.1 minutes Melphalan 5 mg/mL, >240 minutes Cisplatin 1.0 mg/mL, >240 minutes Methotrexate 25 mg/mL, >240 minutes Cyclophosphamide (Cytoxan) 20 mg/mL, >240 minutes Mitomycin C 0.5 mg/mL, >240 minutes Cytarabine 100 mg/mL, >240 minutes Mitoxantrone 2 mg/mL, >240 minutes Dacarbazine (DTIC) 10 mg/mL, >240 minutes Paclitaxel (Taxol) 6 mg/mL, >240 minutes Daunorubicin 5 mg/mL, >240 minutes Rituximab 10 mg/mL, >240 minutes Docetaxel 10 mg/mL, >240 minutes Thiotepa 10 mg/mL, 27.9 minutes Doxorubicin Hydrochloride 2 mg/mL, >240 minutes Trisenox 1 mg/mL, >240 minutes Epirubicin (Ellence) 2 mg/mL, >240 minutes Vincristine Sulfate 1 mg/mL, >240 minutes Etoposide (Toposar) 20 mg/mL, >240 minutes Fludarabine 25 mg/mL, >240 minutes Fluorouracil 50 mg/mL, >240 minutes Gemcitabine 38 mg/mL, >240 minutes Idarubicin 1 mg/mL, >240 minutes Fentanyl tested as follows: Fentanyl citrate 100 mcg/2mL, >240 minutes WARNING: Not for use with Carmustine or Thiotepa.

Source page: https://510kreport.com/device/K193581
Methodology: https://510kreport.com/methodology