# K982691: Multi-Comfort Powdered Examination Gloves with Protein Content Labeling Claim (200 Micrograms or Less)

- Pathway: 510(k) (Traditional)
- Applicant: Perusahaan Intan Emas Sdn. Bhd.
- Decided: Oct 9, 1998 after 67 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
Latex Examination Glove is a disposable medical device intended for medical handling purposes that is womn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the blood, other body fluids, mucous membranes, or non-intact skin of patient.

Source page: https://510kreport.com/device/K982691
Methodology: https://510kreport.com/methodology