# K053305: Senstouch Powdered Examination Gloves, Non Sterile

- Pathway: 510(k) (Traditional)
- Applicant: Pt Mahakarya Inti Buana
- Decided: Jun 2, 2006 after 186 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
A Powdered Latex Examination Glove Non Sterile is a disposable device made of natural rubber latex that bears powder to facilitate donning and is intended to be worn on the hand of finger(s) for a medical purpose to provide a barrier againts potentially insfectious material and other contaminations.

Source page: https://510kreport.com/device/K053305
Methodology: https://510kreport.com/methodology