# K960247: Ultra Care Powder Free Hypoallergenic Patient Examination Glove

- Pathway: 510(k) (Traditional)
- Applicant: Tillotson Healthcare Corp.
- Decided: Jul 29, 1996 after 195 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 K910383 (1991). 1 ancestor in all.
2 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)
- K910383: Hpi Sensi-Shield Glove Kit, Hpi, Inc. (1991) Summary page 1.

## Cited in the summary but kept off the family tree
- K891936: Patient Examination Gloves (Latex), Ku Shing Industries Sdn. Bhd. (1989). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K982505: Ultra Care Non-Sterile Powder Free (Green) Natural Rubber Latex Patient Examination Glove (1999), 1 descendant of its own
- K021007: Ultra Preserve with Aloe Vera (Green) Natural Rubber Latex Examination Glove Made From Allotex an Enzyme Treated Natural (2002), 0 descendants of its own

## Indications for use
This is a disposable device, intended for medical purposes, that is worn on the examiner's hand to prevent contamination between patient and examiner. Hypoallergenic patient examination gloves are suitable in situations where healthcare worker or patient allergic sensitivity may be a factor. Powder free gloves are intended for use in situations where powder should not be used.

Source page: https://510kreport.com/device/K960247
Methodology: https://510kreport.com/methodology