# K960225: Powder Free Plus Hypoallergenic (with Labeled Protein Content) Patient Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Tillotson Healthcare Corp.
- Decided: Jul 29, 1996 after 194 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). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954855: Powder Free Plus Patient Examination Glove, Tillotson Healthcare Corp. (1995) Summary page 1.
- K910383: Hpi Sensi-Shield Glove Kit, Hpi, Inc. (1991) Summary page 1.

## 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. Gloves with labeled protein content are suitable in situations where health care worker or patient allergic sensitivity may be a factor, Powder free gloves are intended for use in situations where powder should not be used. Hypoallergenic gloves are appropriate for users who may have a previous sensitivity.

Source page: https://510kreport.com/device/K960225
Methodology: https://510kreport.com/methodology