# K073299: Blue Latex Exam Gloves Non Sterile Chlorinated Powder Free

- Pathway: 510(k) (Traditional)
- Applicant: Betel Care Sdn. Bhd.
- Decided: Mar 5, 2008 after 103 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
A patient examination gloves is a disposable device intended for medical purposes worm on the examiners hand to prevent contamination between patient and examiner. This gloves is intended for medical and dental Use.

Source page: https://510kreport.com/device/K073299
Methodology: https://510kreport.com/methodology