# K980916: Powder-Free Latex Examination Gloves with Protein Labeling Claim

- Pathway: 510(k) (Traditional)
- Applicant: Perusahaan Getah Asas Sdn. Bhd.
- Decided: Aug 18, 1998 after 160 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
A patient examination glove that is worn on the examiner's hand in order to prevent contamination between patient and examiner. This glove contains 50 milligrams or less of total water extractable protein.

Source page: https://510kreport.com/device/K980916
Methodology: https://510kreport.com/methodology