# K052666: Non-Sterile Powder Free Natural/Green Lano-E Latex Exam Gloves, with or Wihout Citrus/Peppermint Scent Plus a Protein

- Pathway: 510(k) (Traditional)
- Applicant: Ascend Eagle, Inc.
- Decided: Jan 25, 2006 after 120 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: 2 generations back to K011370 (2001). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032293: Non-Sterile, Powder Free Green Latex Examination Gloves with or Without Sour Apple or Peppermint Scenting Plus a Protein, Sgmp Co., Ltd. (2003) Summary page 1.
- K013163: Uniglove Lano-E Powder-Free Latex Examination Gloves, N.S. Uni-Gloves Sdn. Bhd. (2002) Summary page 1.

## Indications for use
The Non-Sterile, Powder-Free, Latex Examination Gloves, with Lanolin and Vitamin E Coating, Natural or Green Color, With or Without Scent (Combined Citrus-Peppermint), and with Protein Labeling Claim (50 micrograms or less total water extractable protein per gram of glove) 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/K052666
Methodology: https://510kreport.com/methodology