# K011370: Non-Sterile Powder Free Purple Latex Examination Glove with and Without Grape Scent and with Protein Labeling (50 Microg

- 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; 2 cite 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
- K032293: Non-Sterile, Powder Free Green Latex Examination Gloves with or Without Sour Apple or Peppermint Scenting Plus a Protein (2003), 1 descendant of its own
- K052666: Non-Sterile Powder Free Natural/Green Lano-E Latex Exam Gloves, with or Wihout Citrus/Peppermint Scent Plus a Protein (2006), 0 descendants of its own
- K032294: Non-Sterile, Powder Free Orange Latex Examination Gloves W/ or Without Orange/Vanilla Scenting Plus a Protein Labeling (2003), 0 descendants of its own

Source page: https://510kreport.com/device/K011370
Methodology: https://510kreport.com/methodology