# K955464: Tactylon Powder Free Examination Glove

- Pathway: 510(k) (Traditional)
- Applicant: Tactyl Technologies, Inc.
- Decided: Apr 25, 1996 after 147 days
- Product code: LZA (Polymer 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 K905109 (1990). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K905109: Patient Examination Glove/Hypoallergenic, Tactyl Technologies, Inc. (1990) Summary page 1.

## Most influential descendants
- K022095: Duraclean with Lycra Powder Free Polyurethane Medical Examination Glove (2002), 0 descendants of its own

## Indications for use
The examination 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/K955464
Methodology: https://510kreport.com/methodology