# K052273: Polymer Coated Latex Examination Gloves, Powder Free, Non-Sterile

- Pathway: 510(k) (Traditional)
- Applicant: Pt Mahakarya Inti Buana
- Decided: Sep 30, 2005 after 39 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
Polymer Examination Glove , Powder Free Non Sterile is a disposable device and made of Synthetic Polymer that exhibits rubber like characteristics intended for medical purpose that is worn on the examiner's hand or finger or prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K052273
Methodology: https://510kreport.com/methodology