Modified American Lubricating Jelly, 2.7 & 5.0
FDA 510(k) K882506 · Span-America Medical Systems, Inc.
510(k) numberK882506
Submission
- Device name
- Modified American Lubricating Jelly, 2.7 & 5.0
- Applicant
- Span-America Medical Systems, Inc.
Greenville, SC, US - Received
- June 9, 1988
- Decision date
- September 9, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K973169 | Pressure Guard Site Select (a)FNM · Traditional | 02/20/1998SE |
| K972486 | Pressureguard IVIKZ · Traditional | 02/20/1998SE |
| K960188 | Pressureguard: SelectcareFNM · Traditional | 10/02/1996SE |
| K961502 | Lubricating Jelly, Low ViscosityKMJ · Traditional | 07/18/1996SE |
| K961159 | Powered Low Air Loss Mattress SystemFNM · Traditional | 06/14/1996SE |
| K960620 | Pressureguard: Low Air Loss Mattress SystemFNM · Traditional | 04/25/1996SE |
| K960189 | Gel-T CushionKIC · Traditional | 02/07/1996SE |
| K954766 | Pressure Guard Alternating Pressure MattressFNM · Traditional | 01/11/1996SE |
| K953503 | Pressureguard IVFNM · Traditional | 10/24/1995SE |
| K954117 | Customcare Seating SystemKIC · Traditional | 10/13/1995SE |
Questions and answers
When was Modified American Lubricating Jelly, 2.7 & 5.0 cleared by the FDA?
Modified American Lubricating Jelly, 2.7 & 5.0 (K882506) received a 510(k) decision of Substantially Equivalent on September 9, 1988, 92 days after the submission was received.
What is the product code of K882506?
The FDA product code is KMJ – Lubricant, Patient, a Class I (low risk) device regulated under 21 CFR 880.6375.