# K111923: Skin Guard, Powder Free Latex Examination Gloves, Non-Sterile

- Pathway: 510(k) (Abbreviated)
- Applicant: Pt. Intan Hevea Industry
- Decided: Nov 4, 2011 after 120 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
Longest line of descent: 1 generation back to K894480 (1989). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K894480: Patient Examination Gloves, Pt. Intan Hevea Industry (1989) Summary page 1.

## Indications for use
Powder Free Latex Examination Gloves, Non Sterile (contains 50 micrograms/dm 2 or less of total water extractable protein) is a disposable device and made of Natural Rubber Latex intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K111923
Methodology: https://510kreport.com/methodology