E-Z LUBRICATING JELLY

K041060 · Chester Labs, Inc. · KMJ · May 7, 2004 · General Hospital

Device Facts

• Record ID: K041060
• Device Name: E-Z LUBRICATING JELLY
• Applicant: Chester Labs, Inc.
• Product Code: KMJ · General Hospital
• Decision Date: May 7, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6375
• Device Class: Class 1
• Attributes: 3rd-Party Reviewed

Intended 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.

Device Story

E-Z Lubricating Jelly is a topical lubricant used to facilitate the insertion of diagnostic or therapeutic medical devices into body orifices. It is available in both sterile and non-sterile formulations to accommodate different clinical requirements, including procedures where a sterile field is necessary. The product is applied by healthcare professionals or patients to reduce friction during medical examinations or interventions. It functions as a physical barrier and lubricant to enhance patient comfort and ease of device entry.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Patient lubricant; topical gel formulation; sterile and non-sterile versions; Class I device.

Indications for Use

Indicated for lubrication of body orifices to facilitate entry of diagnostic or therapeutic devices. Suitable for both sterile and non-sterile clinical applications.

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 7 2004

Chester Labs, Incorporated C/O Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street NW Buffalo, Minnesota 55313

Re: K041060

Trade/Device Name: E-Z Lubricating Jelly Regulation Number: 880.6375 Regulation Name: Patient Lubricant Regulatory Class: I Product Code: KMJ Dated: April 19, 2004 Received: April 23, 2004

Dear Mr. Job: -

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Mcdical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 -Mr. Job

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. or the Act of ally with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 11 Jou donto the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You entitious "Theormation on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

CwLs

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known): _ KO4 | 060

Device Name: E-Z Lubricating Jelly

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.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use る (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Antar Dm

(Division Sign-Off) (Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: 上文中1466