# K023577: Powder Free Latex Exam Gloves, Poly Coated Natural and/or Colored, with Protein Labeling (<50UN/G)

- Pathway: 510(k) (Traditional)
- Applicant: Yty Industry (Manjung) Sdn Bhd
- Decided: Dec 6, 2002 after 44 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 K000156 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K014134: Powder-Free Latex Exam Gloves with Protein Labeling (<50UG/G), Supergrade Healthcare Products Sdn. Bhd. (2002)
- K000156: Smart Shield Non-Sterile Powder-Free Peppermint Scented Green Latex Examination Gloves, Shield Gloves Manufacturer (M) Sdn Bhd (2000)

## Indications for use
A 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/K023577
Methodology: https://510kreport.com/methodology