# K192315: Medline Green Ambidextrous Power-Free Nitrile Examination Gloves with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs)

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: Jan 10, 2020 after 137 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: 3 generations back to K160562 (2016). 3 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180696: Medline Green Ambidextrous Powder-Free Nitrile Examination Gloves with Colloidal Oatmeal (Tested for use with Chemotherapy Drugs), Medline Industries, Inc. (2018) Summary page 5.

## Most influential descendants
- K211220: Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs (2021), 5 descendants of its own
- K213040: Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs,  Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs,Nitrile Patient Examination Gloves Black Tested For Use With Chemotherapy Drugs (2022), 3 descendants of its own
- K261793: Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color) (2026), 0 descendants of its own
- K221747: Nitrile Patient Examination Gloves Tested For Use With Chemotherapy Drugs (2022), 0 descendants of its own
- K223235: Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs) (2022), 0 descendants of its own

## Indications for use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner’s hand to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Blenoxane (Bleomycin) 15.0 mg/ml >240 minutes Bortezomib 1.0 mg/ml >240 minutes Busulfan 6.0 mg/ml >240 minutes Carboplatin 10.0 mg./ml >240 minutes Carmustine (BCNU) 3.3 mg/ml 13.2 minutes Cetuximab (Eributux) 2.0 mg/ml >240 minutes Cisplatin 1.0 mg/ml >240 minutes Cyclophosphamide (Cytoxan) 20.0 mg/ml >240 minutes Dacarbazine (DTIC)10.0 mg/ml >240 minutes Docetaxel 10.0 mg/ml >240 minutes Doxorubicin Hydrochloride 2.0 mg/ml >240 minutes Epirubicin (Ellence) 2.0 mg/ml >240 minutes Etoposide (Toposar) 20.0 mg/ml >240 minutes Fludarabine 25.0 mg/ml >240 minutes Fluorouracil 50.0 mg/ml >240 minutes Gemcitabine (Gemzar) 38.0 mg/ml >240 minutes Idarubicin 1.0 mg/ml >240 minutes Ifosfamide 50.0 mg/ml >240 minutes Irinotecan 50.0 mg/ml >240 minutes Mechlorethamine HCI 1.0 mg/ml >240 minutes Melphalan 5.0 mg/ml >240 minutes Methotrexate 25.0 mg/ml >240 minutes Mitomycin C 0.5 mg/ml >240 minutes Mitoxantrone 2.0 mg/ml >240 minutes Oxaliplatin 5.0 mg/ml >240 minutes Paclitaxel (Taxol) 6.0 mg/ml >240 minutes Paraplatin 10.0 mg/ml >240 minutes Pemetrexed 25.0 mg/ml >240 minutes Raltitrexed 0.5 mg/ml >240 minutes Rituximab 10.0 mg/ml >240 minutes Thiotepa 10.0 mg/ml 44 minutes Trisonex (Arsenic Trioxide) 1.0 mg/ml >240 minutes Vidaza (Azacitidine) 25.0 mg/ml >240 minutes Vinblastine 1.0 mg/ml >240 minutes Vincristine Sulfate 1.0 mg/ml >240 minutes Vinorelbine 10.0 mg/ml >240 minutes

Source page: https://510kreport.com/device/K192315
Methodology: https://510kreport.com/methodology