# K991746: Royal Shield Powder-Free Pineapple Scented Latex Examination Glove with Protein Content Labeling Claim (50 Micrograms or

- Pathway: 510(k) (Traditional)
- Applicant: Shield Gloves Manufacturer (M) Sdn Bhd
- Decided: Jun 23, 1999 after 33 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
Longest line of descent: 1 generation back to K953496 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953496: Royal Shield Non-Sterile Powder-Free Hypoallergenic Latex Examination Gloves, Shield Gloves Manufacturer (M) Sdn Bhd (1995) Summary page 4.

## Indications for use
This is a medical glove to be worn 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/K991746
Methodology: https://510kreport.com/methodology