# K905109: Patient Examination Glove/Hypoallergenic

- Pathway: 510(k) (Traditional)
- Applicant: Tactyl Technologies, Inc.
- Decided: Nov 21, 1990 after 8 days
- Product code: FMC (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
No predicates in its family tree.
2 later devices descend 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K955464: Tactylon Powder Free Examination Glove (1996), 1 descendant of its own
- K022095: Duraclean with Lycra Powder Free Polyurethane Medical Examination Glove (2002), 0 descendants of its own

Source page: https://510kreport.com/device/K905109
Methodology: https://510kreport.com/methodology