# K022765: Nitrile Powder-Free Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Allegiance Healthcare Corp.
- Decided: Oct 11, 2002 after 52 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.
19 later devices descend from it; 4 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Flexam Nitrile T Ambi Examination Gloves: named in the summary without a submission number

## Most influential descendants
- K110921: Nitrile Powder-Free Examination Gloves Tested for Use with Chemotherapy Drugs (2011), 7 descendants of its own
- K141623: Emg Blue Nitrile Medical Examination Glove with Chemotherapy Drug Labeling Claim (2014), 6 descendants of its own
- 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
- K152542: Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for Use with Chemotherapy Drugs (2015), 3 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 or finger to prevent contamination between patient and examiner. In addition, these gloves are worn to protect the wearer against exposure to chemotherapy drugs.

Source page: https://510kreport.com/device/K022765
Methodology: https://510kreport.com/methodology