# K112612: Powder Free Latex Patient Examination Glove, with Protein Content Labeling Claim

- Pathway: 510(k) (Traditional)
- Applicant: Top Calibre Sdn Bhd
- Decided: Jan 18, 2012 after 133 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 K092492 (2009). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092492: Powder Free Polymer Coated Latex Examination Gloves, Non-Sterile, with Protein Labeling Claim of 50 Micrograms Per DM2 O, Wear Safe (Malaysia) Sdn. Bhd. (2009) Summary page 1.

## Most influential descendants
- K153744: A1 Glove Powder Free Latex Patient Examination Gloves with Protein Content Labeling Claim (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein) (2016), 0 descendants of its own

## 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/K112612
Methodology: https://510kreport.com/methodology