E-Z Lubricating Jelly
FDA 510(k) K041060 · Chester Labs, Inc.
510(k) numberK041060
Submission
- Device name
- E-Z Lubricating Jelly
- Applicant
- Chester Labs, Inc.
Cincinnati, OH, US - Received
- April 23, 2004
- Decision date
- May 7, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
- Third-party review
- Yes
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 |
| K092488 | Dynarex Sterile Lubricating JellyKMJ · Traditional | Dynarex Corporation | 12/18/2009SE |
| K083189 | Steri-Lub Lubrication GelKMJ · Special | Avail Medical Products, Inc. | 11/21/2008SE |
More from Avail Medical Products, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K001705 | Statsign Electrode Conductivity Gel, Graham-Field Electrode Conductivity Gel, Models…GYB · Special | 06/29/2000SE |
| K001593 | Modification to Statsign Saline Electrolyte Gel, Graham-Field Saline Electrolyte GelGEI · Special | 06/14/2000SE |
| K944599 | Graham-Field Conductive ECG SprayGYB · Traditional | 05/07/1996SE |
| K944598 | Graham-Field Electrode Conductivity GelGYB · Traditional | 05/07/1996SE |
| K944600 | Graham-Field Saline Electrolyte GelGYB · Traditional | 11/20/1995SE |
| K944597 | Graham-Field Ultrasound Scanning GelIYO · Traditional | 06/21/1995SE |
| K944596 | Graham-Field Ultrasound LotionIMI · Traditional | 06/07/1995SE |
| K940256 | Bioshield Blue Latex GlovesLYY · Traditional | 03/23/1994SE |
| K940254 | Bioshield Blue Powder Free GloveLYY · Traditional | 03/23/1994SE |
| K841871 | Liqua-Sonic GelGYB · Traditional | 03/14/1985SE |
Questions and answers
When was E-Z Lubricating Jelly cleared by the FDA?
E-Z Lubricating Jelly (K041060) received a 510(k) decision of Substantially Equivalent on May 7, 2004, 14 days after the submission was received.
What is the product code of K041060?
The FDA product code is KMJ – Lubricant, Patient, a Class I (low risk) device regulated under 21 CFR 880.6375.