Dynarex Sterile Lubricating Jelly
FDA 510(k) K092488 · Dynarex Corporation
510(k) numberK092488
Submission
- Device name
- Dynarex Sterile Lubricating Jelly
- Applicant
- Dynarex Corporation
Orangeburg, NY, US - Received
- August 13, 2009
- Decision date
- December 18, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KMJ – Lubricant, Patient
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.6375
- Specialty
- General Hospital
Other 510(k)s with product code KMJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K142473 | Lubricating JellyKMJ · Traditional | Sion Biotext Medical , Ltd. | 04/13/2015SE |
| K141028 | Colonglide LubricantKMJ · Special | Pediatric Pharmaceuticals, Inc. | 07/24/2014SE |
| K131617 | Colonglide(R) LubricantKMJ · Traditional | Pediatric Pharmaceuticals, Inc. | 10/03/2013SE |
| K121390 | Lube Jelly SuringeKMJ · Traditional | Nurse Assist, Inc. | 08/10/2012SE |
| K113689 | Dukal Lubricating JellyKMJ · Traditional | Dukal Corporation | 05/04/2012SE |
| K112110 | Sterile Lubricating JellyKMJ · Traditional | Jianerkang Medical Dressing Company | 04/10/2012SE |
| K103718 | Dynacor Lubrication GelKMJ · Traditional | Medline Industries, Inc. | 05/10/2011SE |
| K101522 | Ultra Seal Sterile Lubricating JellyKMJ · Traditional | Ultra Seal Corporation | 12/23/2010SE |
| K083189 | Steri-Lub Lubrication GelKMJ · Special | Avail Medical Products, Inc. | 11/21/2008SE |
| K073684 | Sheffield Pharmaceuticals (Sterile) LubrigelKMJ · Traditional | Sheffield Industries, Div. of Faria , Ltd. | 05/22/2008SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K172266 | Dynarex Three-Way StopcockFMG · Traditional | 03/14/2018SE |
| K152970 | Dynarex Xeroform Petrolatum DressingFRO · Traditional | 10/03/2016SE |
| K151575 | Dynarex Eye CupsLXQ · Traditional | 09/01/2015SE |
| K103086 | Dynarex Intermittent Catheters, Male, Female, PediatricEZD · Traditional | 06/07/2011SE |
| K102637 | Dynarex Ultrasound GelMUI · Traditional | 02/16/2011SE |
| K082863 | Dynarex Enteral Delivery Pump Set with Spike (1000ML), Dynarex Enteral Feeding Sets for…KNT · Traditional | 01/09/2009SE |
| K081569 | Dynarex/Tillotson Non-Sterile Powder Free Blue Nitrile Patient Exam Glove for Use with…LZA · Abbreviated | 09/12/2008SE |
| K052743 | Dynarex CPR Shield with One Way Valve and Barrier Filter, Model 4921CBP · Traditional | 12/22/2005SE |
| K052314 | Dynarex Vaginal Specula 4900, Models 4911-SMALL, 4912-MEDIUM, 4913-LARGEHIB · Traditional | 11/09/2005SE |
| K012816 | Dynarex Iodoform Packing Strips, Models 3411, 3412, 3413, 3414FRO · Traditional | 10/17/2002SE |
Questions and answers
When was Dynarex Sterile Lubricating Jelly cleared by the FDA?
Dynarex Sterile Lubricating Jelly (K092488) received a 510(k) decision of Substantially Equivalent on December 18, 2009, 127 days after the submission was received.
What is the product code of K092488?
The FDA product code is KMJ – Lubricant, Patient, a Class I (low risk) device regulated under 21 CFR 880.6375.