# K000391: Vital Shield Gold Powder Free Latex Examination Gloves with Protein Content Labeling Claim (50 Micrograms or Less)

- Pathway: 510(k) (Traditional)
- Applicant: Sgmp Co., Ltd.
- Decided: Apr 12, 2000 after 65 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 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
- K020042: Hycare Latex Examination Glove, Powder Free (2002), 1 descendant of its own
- K211209: Hycare Med+ Nitrile Examination Gloves; Hycare Touch Latex Examination Gloves (2021), 0 descendants of its own

Source page: https://510kreport.com/device/K000391
Methodology: https://510kreport.com/methodology