# K200150: Medline Powder-Free Orange Nitrile Patient Examination Glove (Tested for use with Fentanyl)

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: Oct 26, 2020 after 278 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: 2 generations back to K090194 (2009). 2 ancestors in all.
1 later device descends from it; 1 cites 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)
- K120890: Powder-Free Nitrie Examination Gloves, Orange, Shen Wei (Usa), Inc. (2012) Summary page 4.

## Most influential descendants
- K220825: Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves (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. It has also been tested for use against Fentanyl Citrate, ASTM D6978-05 (Reapproved 2019, Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs). Drugs Tested: Breakthrough Time (Minutes) Fentanyl Citrate, 100mcg/2mL >240 min

Source page: https://510kreport.com/device/K200150
Methodology: https://510kreport.com/methodology