# K953496: Royal Shield Non-Sterile Powder-Free Hypoallergenic Latex Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Shield Gloves Manufacturer (M) Sdn Bhd
- Decided: Sep 8, 1995 after 44 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K991746: Royal Shield Powder-Free Pineapple Scented Latex Examination Glove with Protein Content Labeling Claim (50 Micrograms or (1999), 0 descendants of its own

Source page: https://510kreport.com/device/K953496
Methodology: https://510kreport.com/methodology