# K063581: Senstouch High Risk Blue Latex Examination Gloves, Powdered, Non Sterile

- Pathway: 510(k) (Traditional)
- Applicant: Pt Mahakarya Inti Buana
- Decided: Mar 15, 2007 after 105 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
senstoacr Hijh RisK Blue Latex Examination Gloves, Powdeced: Non-Sterile- is a disposable device and .nade of aatudcal cubDe' latex foc medical pirPose Unat is wvocf on the examinec'r hand or finger co prewveint contamination oetwee'~l patient ahd exami'ner.

Source page: https://510kreport.com/device/K063581
Methodology: https://510kreport.com/methodology