# K051987: Flexiskin Polymer Coated Latex Examination Gloves, Powder Free, Non-Sterile

- Pathway: 510(k) (Traditional)
- Applicant: Pt. Mandiri Inti Buana
- Decided: Oct 6, 2005 after 76 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 Coated Latex Examination Glove, Powder Free, Non Sterile is a disposable device and made oF Natural Rubber Latex Coated with Polymer 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/K051987
Methodology: https://510kreport.com/methodology