# K080606: Alatech Powdered Latex Patient Examination Glove

- Pathway: 510(k) (Abbreviated)
- Applicant: Alatech Healthcare, LLC
- Decided: Aug 7, 2008 after 156 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
Longest line of descent: 1 generation back to K050527 (2005). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050527: Powdered Latex Examination Gloves with Protein Labeling Claim (Contains 200 Micrograms or Less of Total Water Extractabl, Spi Gloves Sdn. Bhd. (2005) Summary page 2.

## Indications for use
A powdered Patient Examination Glove is a disposable device made of natural rubber latex or synthetic material that bears powder to facilitate donning and is intended to be worn on the hand or finger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants.

Source page: https://510kreport.com/device/K080606
Methodology: https://510kreport.com/methodology