# K990488: Sensiflex Powderfree Latex Examination Glove

- Pathway: 510(k) (Traditional)
- Applicant: Terang Nusa Sdn Bhd
- Decided: May 28, 1999 after 101 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 its predicate without a number.
- (no number) UNISEAL Gloves, powderfree: named in the summary without a submission number

## Indications for use
These examination gloves are for use by healthcare workers or similar personnel during work to prevent cross contamination or cross infection between the user and the patient.

Source page: https://510kreport.com/device/K990488
Methodology: https://510kreport.com/methodology