# K200072: KIMTECH Purple Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, the Opioid Fentanyl, Gastric acid, and Fentanyl in Gastric acid

- Pathway: 510(k) (Traditional)
- Applicant: Kimberly-Clark Corporation
- Decided: Apr 10, 2020 after 87 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). 7 ancestors in all.
3 later devices descend from it; 3 cite 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)
- K170686: Nitrile Examination Gloves, Powder Free [Purple] Tested for Use with Chemotherapy Drugs, Brightway Holdings Sdn. Bhd. (2017) Summary page 6.
- K182241: Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs, Sri Trang Gloves (Thailand) Co., Ltd. (2019) Summary page 6.

## Most influential descendants
- 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
The Nitrile Powder Free patient examination glove is non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. Test Results Follow: Chemotherapy Drug Concentration Minimum Breakthrough Detection Time Blenoxane (15mg/mL),(15,000 ppm) >240 Busulfan (6mg/mL),(6,000 ppm) >240 Carmustine (BiCNU) (3.3mg/mL),(3,300 ppm) >3.6 Cisplatin (lmg/mL),(1,000 ppm) >240 Cyclophosphamide/cytoxan (20mg/mL),(20,000 ppm) >240 Cytarabine (100mg/mL),(100,000 ppm) >240 Dacarbazine(DTIC) (10mg/mL),(10,000 ppm) >240 Daunorubicin (5mg/mL),(5,000 ppm) >240 Docetaxel (10mg/mL),(l 0,000ppm) >240 Doxorubicin (2mg/mL),(2,000 ppm) >240 Ellence (2mg/mL),(2,000 ppm) >240 Etoposide/Toposar (20mg/mL,(20,000 ppm) >240 Fludarabine (25mg/mL),(25,000 ppm) >240 Fluorouracil (50mg/mL),(50,000 ppm) >240 Gemcitabine (38mg/mL),(38,000 ppm) >240 Idarubicin (1mg/mL),(1,000 ppm) >240 Ifosfamide (50mg/mL),(50,000 ppm) >240 Irinotecan (20mg/mL),(20,000 ppm) >240 Mechlorethamine HCL (l mg/mL),(1,000 ppm) >240 Melphalan (5mg/mL),(5,000 ppm) >240 Methotrexate (25mg/mL),(25,000 ppm) >240 Mitomycin C (0.5mg/mL),(500 ppm) >240 Mitoxantrone (2mg/mL),(2,000 ppm) >240 Paclitaxel (6mg/mL),(6,000 ppm) >240 Paraplatin (10mg/mL),(10,000 ppm) >240 Rituximab (10mg/mL),(10,000 ppm) >240 Thiotepa (10mg/mL),(10,000 ppm) >15.9 Trisenox (0.l mg/mL),(100 ppm) >240 Vincristine Sulfate (l mg/ m ),(1,000 ppm) >240 The Fentanyl Citrate and Gastric acid tested as follows: Fentanyl Citrate 100mcg/2mL >240 Gastric Acid (simulated) 0.2% NaCl in 0.7% HCL >240 Fentanyl in Gastric Acid 50/50 Mix >240 Note: Carmustine and Thiotepa have extremely low permeation times of 3.6 and 15.9 minutes respectively Warning: Do Not Use With: Carmustine, Thiotepa

Source page: https://510kreport.com/device/K200072
Methodology: https://510kreport.com/methodology