# K981893: Health + Aid Premium Pre-Powdered Latex Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: M.R.G. Industries Sdn. Bhd.
- Decided: Jun 22, 1998 after 24 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) Class 1 patient examination glove 80LYY: named in the summary without a submission number

## Indications for use
HEALTH + AID © PREMIUM Pre-powdered Latex Examination Glove is a single use device intended for medical purposes that is worn on the hand of health care and similar personnel to prevent contamination between the health care personnel and the patient.

Source page: https://510kreport.com/device/K981893
Methodology: https://510kreport.com/methodology