# K171171: KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs (Blue, Black)

- Pathway: 510(k) (Traditional)
- Applicant: Koon Seng Sdn Bhd
- Decided: Feb 22, 2018 after 307 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 K042805 (2004). 5 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161422: Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs, Wrp Asia Pacific Sdn. Bhd. (2016) Summary page 5.

## Most influential descendants
- K190403: Disposable Powder Free Nitrile Examination Glove, White, Tested for Use With Chemotherapy Drugs, Disposable Powder Free Nitrile Examination Glove, Blue, Tested for Use With Chemotherapy Drugs (2019), 4 descendants of its own
- K193555: Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate (2020), 3 descendants of its own
- K244034: Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate and Xylazine (2025), 1 descendant of its own
- K252244: Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, Xylazine, Gastric acid, Fentanyl in Gastric acid and Xylazine in Gastric acid (2025), 0 descendants of its own
- K230662: Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, And Select Other Drugs (2023), 0 descendants of its own

## Indications for use
A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner’s hand or finger to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs: Test Chemotherapy Drug and Concentration Minimum Breakthrough Detection time in Minutes 1. Carmustine (BCNU), 3.3 mg/ml 22.6 2. Cisplatin, 1.0 mg/ml > 240 3. Cyclophosphamide (Cytoxan), 20.0 mg/ml >240 4. Dacarbazine (DTIC), 10.0 mg/ml > 240 5. Doxorubicin Hydrochloride, 2.0 mg/ml > 240 6. Etoposide (Toposar), 20.0 mg/ml >240 7. Fluorouracil, 50.0 mg/ml > 240 8. Methotrexate, 25 mg/ml > 240 9. Paclitaxel (Taxol), 6.0 mg/ml > 240 10. Thiotepa, 10.0 mg/ml 14.0 The maximum testing time is 240 minutes. Please note that the following drug has an extremely low permeation time: Carmustine (BCNU), 3.3 mg/ml 22.6 minutes Thiotepa, 10.0 mg/ml 14.0 minutes A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner’s hand or finger to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs: Test Chemotherapy Drug and Concentration Minimum Breakthrough Detection Time in Minutes 1. Carmustine (BCNU), 3.3 mg/ml 14.8 2. Cisplatin, 1.0 mg/ml > 240 3. Cyclophosphamide (Cytoxan), 20.0 mg/ml > 240 4. Dacarbazine (DTIC), 10.0 mg/ml > 240 5. Doxorubicin Hydrochloride, 2.0 mg/ml > 240 6. Etoposide (Toposar), 20.0 mg/ml >240 7. Fluorouracil, 50.0 mg/ml > 240 8. Methotrexate, 25 mg/ml > 240 9. Paclitaxel (Taxol), 6.0 mg/ml > 240 10. Thiotepa, 10.0 mg/ml 35.2 The maximum testing time is 240 minutes. Please note that the following drug has an extremely low permeation time: Carmustine (BCNU), 3.3 mg/ml 14.8 minutes Thiotepa, 10.0 mg/ml 35.2 minutes

Source page: https://510kreport.com/device/K171171
Methodology: https://510kreport.com/methodology