# K061553: Non-Sterile, Powder-Free Black Nitrile Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Yty Industry (Manjung) Sdn Bhd
- Decided: Jul 17, 2006 after 42 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. The FDA summary names its predicate without a number.
- (no number) Class I patient examination glove (product code LZA): named in the summary without a submission number

## Most influential descendants
- K123116: Chlorinated Powder Free Nitrile Examination Gloves (Black Colour) (2013), 2 descendants of its own
- K161099: Powder Free Nitrile Examination Gloves, Black (2017), 0 descendants of its own
- K151528: Powder Free Nitrile (Black) Examination Gloves (2015), 0 descendants of its own

## Indications for use
This Non-Sterile, Powder-Free, Black Nitrile 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.

Source page: https://510kreport.com/device/K061553
Methodology: https://510kreport.com/methodology