# K992419: Royal Shield Non-Sterile Blue Colored Powdered Latex Examination Glove with Protein Content Labeling Claim (200 MCGM or

- Pathway: 510(k) (Traditional)
- Applicant: Shield Gloves Manufacturer (M) Sdn Bhd
- Decided: Sep 13, 1999 after 55 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 no predicate by number.

## Indications for use
This is a medical glove to be womn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

Source page: https://510kreport.com/device/K992419
Methodology: https://510kreport.com/methodology