# K051378: Powder-Free Blue Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)

- Pathway: 510(k) (Traditional)
- Applicant: Medline
- Decided: Aug 3, 2005 after 69 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
No predicates in its family tree.
3 later devices descend 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K200960: Medline Powder Free Examination Gloves (Tested for use with Chemotherapy Drugs) (2020), 2 descendants of its own
- 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
Medline Powder-Free Blue Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K051378
Methodology: https://510kreport.com/methodology