# K050527: Powdered Latex Examination Gloves with Protein Labeling Claim (Contains 200 Micrograms or Less of Total Water Extractabl

- Pathway: 510(k) (Traditional)
- Applicant: Spi Gloves Sdn. Bhd.
- Decided: Mar 18, 2005 after 16 days
- Product code: LYY (Latex 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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 Latex Patient Examination Glove SOLYY: named in the summary without a submission number

## Most influential descendants
- K080606: Alatech Powdered Latex Patient Examination Glove (2008), 0 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 hands or finger to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K050527
Methodology: https://510kreport.com/methodology