# K021007: Ultra Preserve with Aloe Vera (Green) Natural Rubber Latex Examination Glove Made From Allotex an Enzyme Treated Natural

- Pathway: 510(k) (Traditional)
- Applicant: Tillotson Healthcare Corp.
- Decided: Jul 5, 2002 after 99 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: 3 generations back to K910383 (1991). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002718: Ultra Care 2 Latex Examination Gloves Made From Allotex (Enzyme Treated) Natural Rubber Latex with a Protein Content Lab, Tillotson Healthcare Corp. (2001) Summary page 1.
- K982505: Ultra Care Non-Sterile Powder Free (Green) Natural Rubber Latex Patient Examination Glove, Tillotson Healthcare Corp. (1999) Summary page 1.
- K013286: Cymunvera Powder Free Green Natural Rubber Latex Patient Examination Glove Lined with Aloe Vera, Tillotson Healthcare Corp. (2001) Summary page 1.

## Indications for use
The Ultra Preserve With Aloe Vera (Green) Examination Glove is "a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.".

Source page: https://510kreport.com/device/K021007
Methodology: https://510kreport.com/methodology