# K111300: Senstouch Nitrile Examination Gloves, Powder Free, Non Sterile (Green, Orange, Violet and White)

- Pathway: 510(k) (Traditional)
- Applicant: Pt Mahakarya Inti Buana
- Decided: Aug 12, 2011 after 95 days
- Product code: LZA (Polymer 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
Green, Orange, Violet and White Nitrile examination gloves, Powder Free, Non - Sterile are disposable device and made of Synthetic Polymer that exhibits rubber like characteristics intended for medical purposes that is worn on the examiner's hand or finger to prevent contaminatiqn between patient and examiner.

Source page: https://510kreport.com/device/K111300
Methodology: https://510kreport.com/methodology