# K040841: Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: Jul 8, 2004 after 98 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.
7 later devices descend from it; 2 cite it directly.
0 of 8 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
- K071072: Shanghai China Star Corp. Powder Free Blue Nitrile Patient Examination Glove (2007), 6 descendants of its own
- K090336: Sunmax Enterprise Shanghai CO. Powder Free Blue Nitrile Patient Examination Glove Tested with Chemotherapy Drugs (2009), 5 descendants of its own
- K102593: Synthetic, Powder-Free Nitrile Examination (2010), 1 descendant of its own
- K101870: Sunmax Vietnam CO. LTD Powder Free White Nitrile Examination Glove (2010), 1 descendant of its own
- K211667: Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile) (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/K040841
Methodology: https://510kreport.com/methodology