# K120693: Latex Examination Gloves (Powdered)

- Pathway: 510(k) (Traditional)
- Applicant: Top Calibre Sdn Bhd
- Decided: May 8, 2012 after 62 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 K003737 (2001). 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)
- K003737: Powdered Latex Patient Examination Glove with Protein Content Labeling Claim (200 Microgramsper or Less), Perusahaan Getah Asas Sdn. Bhd. (2001) Summary page 3.

## Indications for use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K120693
Methodology: https://510kreport.com/methodology