STERILE LUBRICATING JELLY

K112110 · Jianerkang Medical Dressing Company · KMJ · Apr 10, 2012 · General Hospital

Device Facts

• Record ID: K112110
• Device Name: STERILE LUBRICATING JELLY
• Applicant: Jianerkang Medical Dressing Company
• Product Code: KMJ · General Hospital
• Decision Date: Apr 10, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6375
• Device Class: Class 1

Intended Use

The Jianerkang Sterile Lubricating Jelly is intended for medical purposes, to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices when a sterile field is required.

Device Story

Jianerkang Sterile Lubricating Jelly is a clear, greaseless, water-soluble sterile lubricant. It is used in clinical settings to facilitate the insertion of diagnostic or therapeutic devices into body orifices where a sterile field is required. The device is supplied in foil packs or tubes. It functions as a physical lubricant to reduce friction during medical procedures. It is intended for both prescription and over-the-counter use.

Clinical Evidence

No clinical data. Safety established via bench testing and biocompatibility testing per ISO 10993, including in-vitro cytotoxicity, implantation, irritation, hypersensitivity, and systemic toxicity studies.

Technological Characteristics

Water-soluble gel containing purified water, carbomer thickeners, methylparaben, and propylparaben. Packaged in plastic/film laminate. Sterilized via gamma radiation per ISO/AAMI 11137 (SAL 10^-6).

Indications for Use

Indicated for lubrication of body orifices to facilitate entry of diagnostic or therapeutic devices requiring a sterile field. Suitable for use 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

• Dynarex Sterile Lubricating Jelly (K092488)

Submission Summary (Full Text)

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KII2110

APR 1 0 2012

## 510(K) SUMMARY (as required by 807.92 (c))

| Submitter of 510(k): | Jianerkang Medical Dressing Company<br>Zhixi Town<br>Jintan City, Jiangsu, PRC 213251<br>Tel. 0086-519822444628 |
|-------------------------|-----------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jordan Chu<br>Vice General Manager |
| Date of Summary: | March 22, 2012 |
| Trade/Proprietary Name: | Jianerkang Sterile Lubricating Jelly |
| Classification Name: | Lubricant, Patient<br>21 C.F.R. § 880.6375<br>Class I |
| Common Name | Sterile Lubricating Jelly |
| Product Code: | KMJ |

Intended Use: The Jianerkang Sterile Lubricating Jelly is intended for medical purposes, to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices when a sterile field is required.

Device Description: The Jianerkang Sterile Lubricating Jelly is a clear, greaseless, watersoluble sterile lubricating jelly.

Device Packaging: A typical packaging configuration for the Jianerkang Sterile Lubricating Jelly is 2.7g or 5gm foil packs and 2oz or 4oz tubes. Other sizes may become available.

Predicate Device: Dynarex Sterile Lubricating Jelly, 510(k) K092488 is manufactured for Dynarex, 10 Glenshaw St., Orangeburg, NY 10962.

Substantial Equivalence: The Jianerkang Sterile Lubricating Jelly provides effective lubrication for the insertion of diagnostic and therapeutic devices into body orifices. Its function, performance, technological characteristics, and indications for use are substantially equivalent to the predicate device as presented in this 510(k).

Safety and Effectiveness of the Device is as safe and effective as the predicate device based on the following:

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# 510(K) SUMMARY (as required by 807.92 (c))

# Summary comparing technological characteristics with predicate device:

| TECHNOLOGICAL<br>CHARACTERISTICS | Jianerkang Sterile Lubricating Jelly | Dynarex Sterile Lubricating Jelly |
|-------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Purified Water | YES | YES |
| Carborner thickeners | YES | YES |
| Methylparaben and<br>Propylparaben | YES | YES |
| Labeled water soluble | YES | YES |
| Labeled colorless | YES | Labeled "Non Staining" |
| Labeled alcohol and<br>fragrance free | YES | YES |
| Container material | Plastic/Film Laminate | Plastic/Film Laminate |
| Sterile | YES | YES |
| Physical Tests | | |
| Biocompatibility<br>Testing | ISO 10993<br>In-Vitro Cytotoxicity - Pass<br>Implantation - Pass<br>Irritation & Hypersensitivity-Pass<br>Systemic Toxicity -- Pass | ISO 10993<br>In-Vitro Cytotoxicity - Pass<br>Implantation - Pass<br>Irritation & Hypersensitivity-Pass<br>Systemic Toxicity -- Pass |
| In-Vitro Cytotoxicity -<br>Pass* Grade 2 Result<br>Response | YES | YES |

Sterilization: The Jianerkang Sterile Lubricating Jelly is sterilized by gamma radiation under parameters that have been validated according to ISO/AAMI 11137 requirements (sterilization of health care products - requirements for validation and routine control - radiation sterilization) with an SAL of 10th.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Jordan Chu Vice General Manager Jianerkang Medical Dressing Company Zhixi Town Jintan City, Jiangsu CHINA 213251

Re: K112110

Trade/Device Name: Sterile Lubricating Jelly Regulation Number: 21 CFR 880.6375 Regulation Name: Patient Lubricant Regulatory Class: I Product Code: KMJ Dated: February 22, 2012 Received: February 29, 2012

### Dear Mr. Chu:

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 Medical 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

APR 1 0 2012

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### Page 2 -- Mr. Chu

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. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information 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.goy/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Anthony D. Watson, B.S., M.S., M.B.A. 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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# INDICATIONS FOR USE

510(k) Number: K112110

Device Name: Sterile Lubricating Jelly

Indications for Use:

The Jianerkang Sterile Lubricating Jelly is intended for medical purposes, to lubricate body orifices to facilitate entry of diagnostic and therapeutic devices when a sterile field is required.

Prescription Use (21 C.F.R. Part 801, Subpart D)

AND/OR

Over-the-Counter Use X (21 C.F.R. Part 801, Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number: K112110

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