# K041060: E-Z Lubricating Jelly

- Pathway: 510(k) (Traditional)
- Applicant: Chester Labs, Inc.
- Decided: May 7, 2004 after 14 days
- Product code: KMJ (Lubricant, Patient)
- Device class: 1
- Regulation: 21 CFR 880.6375
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K092488: Dynarex Sterile Lubricating Jelly (2009), 3 descendants of its own
- K073684: Sheffield Pharmaceuticals (Sterile) Lubrigel (2008), 1 descendant of its own
- K142473: Lubricating Jelly (2015), 0 descendants of its own
- K113689: Dukal Lubricating Jelly (2012), 0 descendants of its own
- K112110: Sterile Lubricating Jelly (2012), 0 descendants of its own

## Recalls of this device
- Dec 12, 2016 · Class II · Z-0984-2017: Product was not sterilized. Product was shipped to distribution centers instead of the sterilization facility due to an operations error by a 3rd party shipping company.

## Indications for use
E-Z Lubricating Jelly is a medical device intended for medical purposes to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices. E-Z Lubricating Jelly (sterile) is a medical device Intended for medical purposes to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices when a sterile field Is required.

Source page: https://510kreport.com/device/K041060
Methodology: https://510kreport.com/methodology