← Product Code [KMJ](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KMJ) · K961502

# LUBRICATING JELLY, LOW VISCOSITY (K961502)

_Span-America Medical Systems, Inc. · KMJ · Jul 18, 1996 · General Hospital · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KMJ/K961502

## Device Facts

- **Applicant:** Span-America Medical Systems, Inc.
- **Product Code:** [KMJ](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KMJ.md)
- **Decision Date:** Jul 18, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.6375
- **Device Class:** Class 1
- **Review Panel:** General Hospital

## Indications for 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.

## Regulatory 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](/device/K882506.md))

## Submission Summary (Full Text)

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{0}

JUL 18 1996
K961502
SPAN-AMERICA
MEDICAL SYSTEMS, INC.

# 510 SUMMARY
## LUBRICATING JELLY, LOW VISCOSITY

1.0. SUBMITTER: Span-America Medical Systems, Inc.
ADDRESS: 70 Commerce Center; Greenville, SC 29615
TELEPHONE: 864-288-8877
FACSIMILE: 864-288-8692

CONTACT PERSON: Wanda J. Totton, Director of Quality
Polly Thompson, Manager of Quality Assurance

DATE PREPARED: April 15, 1996

2.0. TRADE NAME: Lubricating Jelly

COMMON NAME: Lubricating Jelly
CLASSIFICATION NAME: Lubricant, Patient

3.0. PREDICATE DEVICE: Lubricating Jelly, 510K882506

4.0. DESCRIPTION: Lubricating Jelly is a patient lubricant intended for medical purposes that is used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.

5.0. INDICATIONS FOR USE: To lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.

6.0. SUBSTANTIAL EQUIVALENCE: The product is similar in function and intended use to Lubricating Jelly, 510K882506.

WPWINIA:TOTTON\LUBE510K.C96
P.O. Box 5231, Greenville, SC 29606 - 803-222-2277

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KMJ/K961502](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KMJ/K961502)

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