LUBRICATING JELLY, LOW VISCOSITY

K961502 · Span-America Medical Systems, Inc. · KMJ · Jul 18, 1996 · General Hospital

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

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.

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)

Submission Summary (Full Text)

{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: [phone]
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