# K991304: Health + Aid Premium Powder Free Nitrile Examination Gloves, Blue

- Pathway: 510(k) (Traditional)
- Applicant: M.R.G. Industries Sdn. Bhd.
- Decided: Jun 23, 1999 after 68 days
- Product code: LZA (Polymer 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 (Nitrile) 80LZA: named in the summary without a submission number

## Indications for use
HEALTH + AID ® PREMIUM Powderfree Nitrile 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/K991304
Methodology: https://510kreport.com/methodology