← Product Code [KMJ](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KMJ) · K092488 # DYNAREX STERILE LUBRICATING JELLY (K092488) _Dynarex Corporation · KMJ · Dec 18, 2009 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KMJ/K092488 ## Device Facts - **Applicant:** Dynarex Corporation - **Product Code:** [KMJ](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KMJ.md) - **Decision Date:** Dec 18, 2009 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.6375 - **Device Class:** Class 1 - **Review Panel:** General Hospital ## Indications for Use Dynarex Sterile Lubricating Jelly 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 Dynarex Sterile Lubricating Jelly is a clear, greaseless, water-soluble lubricant. It is applied to body orifices to reduce friction during the insertion of diagnostic or therapeutic medical devices. The product is provided in sterile foil packs (3g, 5g) or tubes (2oz, 4oz). It is intended for use by healthcare professionals in clinical settings requiring a sterile field. The jelly facilitates device entry, potentially increasing patient comfort and reducing trauma during procedures. It is formulated with purified water, carbomer thickeners, and preservatives (methylparaben/propylparaben). ## Clinical Evidence Bench testing only. Evidence includes physical testing (viscosity, pH), preservative effectiveness testing, sterility testing, and comprehensive biocompatibility testing per ISO 10993 (in-vitro cytotoxicity, implantation, irritation, hypersensitivity, and systemic toxicity). All tests passed. ## Technological Characteristics Water-soluble gel containing purified water, carbomer thickeners, and methylparaben. Packaged in plastic/film laminate. Sterilized via gamma irradiation (ISO/AAMI 11137, Vdmax25, SAL 10^-6). Biocompatibility per ISO 10993. ## 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 - E-Z Lubricating Jelly ([K041060](/device/K041060.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ K092488 ## DEC 1 8 2009 ### 510(K) SUMMARY (as required by 807.92(c)) | Submitter of 510(k): | Dynarex Corporation
10 Glenshaw Street
Orangeburg, NY 10972
USA
Phone: (845) 365-8200
Fax: (845) 365-8201 | | |-------------------------|--------------------------------------------------------------------------------------------------------------------------|--| | Contact Person: | Daniel Consaga | | | Date of Summary: | December 17, 2009 | | | Trade/Proprietary Name: | Dynarex Sterile Lubricating Jelly | | | Classification Name: | Lubricant, Patient | | | Product Code: | KMJ | | #### Intended Use: Dynarex Sterile Lubricating Jelly 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 Description: Dynarex Sterile Lubricating Jelly is a clear, greaseless, water soluble jelly. Typical packaging configurations for the Dynarex Sterile Lubricating Jelly is 3 g or 5 g foil packs, and 2 oz or 4 oz tubes, Other sizes may become available. #### Predicate Device: E-Z Lubricating Jelly, 510k Number K041060 is manufactured by Chester Labs, Inc. 1900 Section Rd., Cincinnati, OH 45237. ### Substantial Equivalence: The Dynarex Sterile Lubricating Jelly provides effective lubrication during the insertion of diagnostic and therapeutic devices into body orifices. Its function and performance are similar to the predicate device as presented in this 510(k) #### Safety and Effectiveness of the device: This device is as safe and effective as the predicate device cited above based on . {1}------------------------------------------------ ### 510(K) SUMMARY (as required by 807.92(c)) ### Safety and Effectiveness of the device: This device is as safe and effective as the predicate device cited above based on the following; Summary comparing technological characteristics with other predicate device: Dynarex Sterile Lubricating Jelly is similar in terms of intended use and technological characteristics to predicate devices reviewed as a lubricating jelly to facilitate the entry of a diagnostic or therapeutic device. The device is substantially equivalent with respect to indications for use and other physical characteristics to predicate devices in terms of section 510(k) substantial equivalency. Please find below a tabulated comparison supporting that this device is substantially equivalent to the predicate device in commercial distribution. | TECHNOLOGICAL
CHARACTERISTICS | Dynarex Lubricating Jelly | E-Z Lubricating Jelly | |-------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------| | Purified water | Yes | Yes | | Carbomer thickeners | Yes | Yes | | Methylparaben | Yes | Yes | | Labeled water soluble | Yes | Yes | | Labeled non-staining | Yes | Yes | | Labeled alcohol and
fragrance free | Yes | Yes | | Container material | Plastic/Film Laminate | Plastic | | Sterile | Yes | Yes | | Physical Tests | Viscosity & pH | Viscosity & pH | | | Preservative effectiveness | Preservative effectiveness | | | Sterility Test Study | Sterility Test Study | | | ISO 10993 | ISO 10993 | | Biocompatability
Testing | In-Vitro Cytotoxicity - Pass* | In-Vitro Cytotoxicity - Pass | | | Implantation - Pass | Implantation - Pass | | | Irritation & Hypersensitivity - Pass | Irritation & Hypersensitivity - Pass | | | Systemic Toxicity - Pass | Systemic Toxicity - Pass | | In-Vitro Cytotoxicity -
Pass* Grade 2 Result
Response | The two preservatives (Methylparaben and Propylparaben) are well
known to cause this type result. Sodium Hydroxide also can cause
this phenomena, but the concentration in the gel of sodium
hydroxide is very low (less than 1%) so it is believed that its'
contribution to this grade 2 result is very low if any. | | #### Sterilization: The Dynarex Sterile Lubricating Jelly is sterilized by gamma irradiation 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). Method: Vdmax25 with an SAL of 10-6. {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002 Mr. Daniel Consaga Regulatory Affairs Engineer Dynarex Corporation 10 Glenshaw Street Orangeburg, New York 10962 ### DEC 1 8 3009 Re: K092488 Trade/Device Name: Dynarex Sterile Lubricating Jelly Regulation Number: 21 CFR 880.6375 Regulation Name: Patient Lubricant Regulatory Class: I Product Code: KMJ Dated: October 26, 2009 Received: December 8, 2009 Dear Mr. Consaga: 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. 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. {3}------------------------------------------------ Page 2- Mr. Consaga 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely, Susan Runez 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 {4}------------------------------------------------ # Indications for Use 510(k) Number (if known): Device Name: Dynarex Sterile Lubricating Jelly Indications for Use: Dynarex Sterile Lubricating Jelly 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 _ (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) An Stin for liz (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: K 992488 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KMJ/K092488](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KMJ/K092488) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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