# K052016: Non-Sterile Powder Free Multicolor - Red, Blue, Purple and Yellow Latex Examination Gloves with Protein Content Labeling

- Pathway: 510(k) (Traditional)
- Applicant: Sgmp Co., Ltd.
- Decided: Sep 1, 2005 after 37 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 K011377 (2001). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011377: Non-Sterile Powder-Free Blue Latex Examination Gloves, with and Without Bubblegum Scenting & a Protein Labeling Claim (5, Sgmp Co., Ltd. (2001)
- K011371: Non-Sterile Powder Free Pink Latex Examination Glove and Non-Sterile Powder Free Pink Latex Examination Glove with Straw, Sgmp Co., Ltd. (2001) Summary page 1.

## Most influential descendants
- 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

## Indications for use
The Non-Sterile, Latex, Powder-Free Patient Examination Gloves (Multicolored), with Protein Labeling Claim (50 Micrograms or less) is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K052016
Methodology: https://510kreport.com/methodology