# K083761: Alatech Powder Free Latex Examination Glove

- Pathway: 510(k) (Abbreviated)
- Applicant: Alatech Healthcare, LLC
- Decided: Jul 22, 2009 after 216 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.
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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
A powder free Patient Examination Glove is a disposable device -made of natural rubber latex or synthetic material intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between the patient and'examiner. and as a barrier against potentially infectious materials and other contaminants.

Source page: https://510kreport.com/device/K083761
Methodology: https://510kreport.com/methodology