# K003867: Exam Room Astroglide (Professional Market), Target Lubricating Jelly (Otc Consumer Market)

- Pathway: 510(k) (Traditional)
- Applicant: Biofilm, Inc.
- Decided: Mar 9, 2001 after 87 days
- Product code: NUC (Lubricant, Personal)
- Device class: 2
- Regulation: 21 CFR 884.5300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
A lubricant for non-sterile gynecological and hospital procedures. Not harmful to rubber appliances or medical instruments. Recommended for personal lubrication when vaginal dryness causes discomfort. Lubrication for insertion of rectal thermometers, enemas, douches, and similar types of nozzles.

Source page: https://510kreport.com/device/K003867
Methodology: https://510kreport.com/methodology