# K170686: Nitrile Examination Gloves, Powder Free [Purple] Tested for Use with Chemotherapy Drugs

- Pathway: 510(k) (Traditional)
- Applicant: Brightway Holdings Sdn. Bhd.
- Decided: Jul 14, 2017 after 129 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 K992162 (1999). 1 ancestor in all.
4 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992162: Safeskin Purple Powder-Free Nitrile Examination Gloves for Use with Chemotherapeutic Drugs Labeling Claim, Safeskin Corp. (1999) 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
- 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
- K231021: KIMTECH™ Polaris™ 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
- K202416: Kimtech Prizm Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid, Kimtech Prizm Xtra Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid (2020), 0 descendants of its own

## Indications for use
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS is a disposable device intended for medical purpose worn on the examiners hand or finger to prevent contamination between patient and examiner. The tested chemotherapy drugs and their breakthrough detection times are as follows: Test Chemotherapy Drug Name and Concentration — Minimum Breakthrough Detection Time Blenoxane (15mg/ml), (15,000 ppm) — >240 Minutes Busulfan (6mg/ml), (6,000 ppm) — >240 Minutes Carmustine (BCNU) (3.3mg/ml), (3,300 ppm) — 3.6 Minutes Cisplatin (1.0mg/ml), (1,000 ppm) — >240 Minutes Cyclophosphamide/Cytoxan (20mg/ml), (20,000 ppm) — >240 Minutes Cytarabine (100mg/ml), (100,000 ppm) — >240 Minutes Dacarbazine (DTIC) 10mg/ml, (10,000 ppm) — >240 Minutes Daunorubicin (5mg/ml), (5,000 ppm) — >240 Minutes Docetaxel (10mg/ml), (10,000 ppm) — >240 Minutes Doxorubicin HCL (2mg/ml), (2,000 ppm) — >240 Minutes Ellence (2mg/ml), (2,000 ppm) — >240 Minutes Etoposide /Toposar (20mg/ml), (20,000 ppm) — >240 Minutes Fludarabine (25mg/ml), (25,000 ppm) — >240 Minutes Fluorouracil (50mg/ml), (50,000 ppm) — >240 Minutes Gemcitabine (38mg/ml), (38,000 ppm) — >240 Minutes Idarubicin (1.0mg/ml), (1,000 ppm) — >240 Minutes Ifosfamide (50mg/ml), (50,000 ppm) — >240 Minutes Irinotecan (20mg/ml), (20,000 ppm) — >240 Minutes Mechlorethamine HCI (1.0mg/ml), (1,000 ppm) — >240 Minutes Melphalan (5mg/ml), (5,000 ppm) — >240 Minutes Methotrexate (25mg/ml), (25,000 ppm) — >240 Minutes Mitomycin C (0.5 mg/ml), (500 ppm) — >240 Minutes Mitoxantrone (2mg/ml), (2,000 ppm) — >240 Minutes Paclitaxel (6.0mg/ml), (6,000 ppm) — >240 Minutes Paraplatin (10mg/ml), (10,000 ppm) — >240 Minutes Rituximab (10mg/ml), (10,000 ppm) — >240 Minutes Thiotepa (10mg/ml), (10,000 ppm) — 15.9 Minutes Trisenox (0.1mg/ml), (100 ppm) — >240 Minutes Vincristine Sulfate (1.0mg/ml), (1,000 ppm) — >240 Minutes Please note that Carmustine and Thiotepa have extremely low permeation times of 3.6 minutes and 15.9 minutes, respectively WARNING: Do Not Use With: Carmustine, ThioTEPA

Source page: https://510kreport.com/device/K170686
Methodology: https://510kreport.com/methodology