# K122788: Textured, Natural to Off-White, Latex, Sterile, Powder Free Examination Gloves, with Protein Labeling Claim (50 UG/DM2 O

- Pathway: 510(k) (Traditional)
- Applicant: Northstar Healthcare Holdings
- Decided: Jan 17, 2013 after 128 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 K090327 (2009). 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)
- K090327: Powder Free Polymer Coated Latex Examination Gloves, Sterile, with Protein Labeling Claim of 50 UG Per DM2 of Glove, Wear Safe (Malaysia) Sdn. Bhd. (2009) Summary page 1.

## Indications for use
The 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/K122788
Methodology: https://510kreport.com/methodology