# K022343: Glovetex Powder Free Latex Examination Gloves, Non Sterile (Protein Content Labeling Claim 50UG/G or Less)

- Pathway: 510(k) (Traditional)
- Applicant: Pt. Wrp Buana Multicorpora
- Decided: Sep 16, 2002 after 59 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 K970115 (1997). 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)
- K970115: Powder Free Latex Examination Gloves, Pt Mbf Buana Multicorpora (1997) Summary page 1.

## Indications for use
The Powder Free Latex Examination Gloves, Non-Sterile (Protein Content Labeling 50 pglg or less) is a disposable device and made of Natural Rubber Latex 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/K022343
Methodology: https://510kreport.com/methodology