LUBRICATING JELLY, LOW VISCOSITY
Device Facts
| Record ID | K961502 |
|---|---|
| Device Name | LUBRICATING JELLY, LOW VISCOSITY |
| Applicant | Span-America Medical Systems, Inc. |
| Product Code | KMJ · General Hospital |
| Decision Date | Jul 18, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6375 |
| Device Class | Class 1 |
Intended Use
To lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.
Device Story
Lubricating jelly; applied to body orifices; facilitates insertion of diagnostic or therapeutic medical devices; used in clinical settings by healthcare professionals; reduces friction during medical procedures; improves patient comfort during device entry.
Clinical Evidence
No clinical data provided; device is a standard lubricating jelly.
Technological Characteristics
Water-based lubricating jelly; non-sterile or sterile (implied by medical use); viscous gel formulation; biocompatible for mucosal contact.
Indications for Use
Indicated for lubrication of body orifices to facilitate entry of diagnostic or therapeutic devices in patients requiring such procedures.
Regulatory Classification
Identification
A patient lubricant is a device intended for medical purposes that is used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.
Predicate Devices
- Lubricating Jelly (K882506)
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- K974768 — PDI STERILE LUBRICATING JELLY · Nice-Pak Products, Inc. · Jan 16, 1998
- K113689 — DUKAL LUBRICATING JELLY · Dukal Corporation · May 4, 2012
