# K011377: Non-Sterile Powder-Free Blue Latex Examination Gloves, with and Without Bubblegum Scenting & a Protein Labeling Claim (5

- Pathway: 510(k) (Traditional)
- Applicant: Sgmp Co., Ltd.
- Decided: Jun 7, 2001 after 34 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.
3 later devices descend from it; 1 cites it directly.
0 of 4 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
- K052016: Non-Sterile Powder Free Multicolor - Red, Blue, Purple and Yellow Latex Examination Gloves with Protein Content Labeling (2005), 2 descendants of its own
- K071060: Non-Sterile, Latex Powder Free Patient Examination Gloves (Multicolored with Xylitol and Calcium Carbonate) (2007), 1 descendant of its own
- K093375: KS-Care Powder Free Polymer Coated Latex Examination Glove with Protein Content Labeling Claim (50UG or Less) (2009), 0 descendants of its own

Source page: https://510kreport.com/device/K011377
Methodology: https://510kreport.com/methodology