# K042239: Flexiskin Powder Free Nitrile Examination Gloves, Non Sterile

- Pathway: 510(k) (Traditional)
- Applicant: Pt. Mandiri Inti Buana
- Decided: Dec 16, 2004 after 120 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 its predicate without a number.
- (no number) Class I Nitrile Examination Gloves, 80LZA, powder free: named in the summary without a submission number

## Indications for use
Powder free Nitrile examination gloves, Non Sterile is a disposable device and make of Synthetic Polymer that exhibits rubber like Characteristics intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K042239
Methodology: https://510kreport.com/methodology