# K100162: Multiple Private Label

- Pathway: 510(k) (Traditional)
- Applicant: Biogreen Yields Sdn.Bhd
- Decided: Mar 24, 2010 after 63 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.
No later device cites it as a predicate yet.
0 of 1 device 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 80LZA): named in the summary without a submission number

## Indications for use
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. This device is for over-the counter use.

Source page: https://510kreport.com/device/K100162
Methodology: https://510kreport.com/methodology