# K081488: Powder Free Latex Examination Gloves, Non-Sterile

- Pathway: 510(k) (Traditional)
- Applicant: Pt. Maja Agung Latexindo
- Decided: Aug 28, 2008 after 92 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 Examination Gloves 80 LYY meeting ASTM D 3578-05ae2: named in the summary without a submission number

## Most influential descendants
- K093375: KS-Care Powder Free Polymer Coated Latex Examination Glove with Protein Content Labeling Claim (50UG or Less) (2009), 0 descendants of its own

## Indications for use
A powder-free 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.

Source page: https://510kreport.com/device/K081488
Methodology: https://510kreport.com/methodology