# K052502: Non-Sterile, Powder-Free Nitrile Blue & White Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Yty Industry (Manjung) Sdn Bhd
- Decided: Nov 18, 2005 after 66 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; 3 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. The FDA summary names its predicate without a number.
- (no number) Class I Nitrile Patient Examination Glove 80 LZA, powder free: named in the summary without a submission number

## Most influential descendants
- K143289: Non-Sterile, Power Free Nitrile Examination Gloves-Orange, Green, Blue and Violet Color (2015), 4 descendants of its own
- K222721: Violet Nitrile Powder Free Patient Examination Glove, Non Sterile (2022), 0 descendants of its own
- K220121: Non Sterile Nitrile Powder Free Examination Gloves – Blue,Green, and Black (2022), 0 descendants of its own
- K210388: Non Sterile Nitrile Powder Free Examination Gloves – Blue, Green and Black color (2021), 0 descendants of its own
- K210587: Violet Nitrile Powder Free Patient Examination Glove, Non Sterile (2021), 0 descendants of its own

## Indications for use
The Non-Sterile, Powder-Free Nitrile Blue & White Examination Gloves 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/K052502
Methodology: https://510kreport.com/methodology