# K200960: Medline Powder Free Examination Gloves (Tested for use with Chemotherapy Drugs)

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industires, Inc.
- Decided: Jul 13, 2020 after 94 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 K051378 (2005). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051378: Powder-Free Blue Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs), Medline (2005) Summary page 4.

## Most influential descendants
- K212735: Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs) (2022), 0 descendants of its own
- K212532: Disposable Powder Free Nitrile Exam Gloves (Tested For Use With Chemotherapy Drugs) (2021), 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. Summarized in Table 1 below, the proposed device was tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Chemotherapy Drug Concentration Breakthrough time Carmustine (BCNU) 3.3 mg/ml (3,300 ppm) 12.4 minutes Cisplatin 1.0 mg/ml (1,000 ppm) >240 minutes Cyclophosphamide (Cytoxan) 20.0 mg/ml (20,000 ppm) >240 minutes Dacarbazine (DTIC) 10.0 mg/ml (10,000 ppm) >240 minutes Doxorubicin Hydrochloride 2.0 mg/ml (2,000 ppm) >240 minutes Etoposide (Toposar) 20.0 mg/ml (20,000 ppm) >240 minutes Fluorouracil 50.0 mg/ ml (50,000 ppm) >240 minutes Methotrexate 25 mg/ml (25,000 ppm) >240 minutes Mitomycin C 0.5 mg/ml (500 ppm) >240 minutes Paclitaxel (Taxol) 6.0 mg/ml (6,000 ppm) >240 minutes ThioTepa 10.0 mg/ml (10,000 ppm) 27.4 minutes Vincristine Sulfate (Oncovin) 1.0 mg/ml (1,000 ppm) >240 minutes Do Not Use with Carmustine or Thiotepa

Source page: https://510kreport.com/device/K200960
Methodology: https://510kreport.com/methodology