Cover, Mattress (Medical Purposes)
The Medical-Purpose Mattress Cover is a protective covering placed over a hospital mattress to provide a hygienic barrier and protect the mattress from contamination, fluid exposure, or damage during patient care. It is classified as FDA Class 1 (lowest risk) and is subject only to general controls. The product code is FMW, regulated under 21 CFR 880.6190 in the General Hospital specialty. This device is exempt from Good Manufacturing Practice (GMP) requirements.
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Basic Information
- Product Code
- FMW
- Device Class
- FDA class 1
- Regulation Number
- 880.6190
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 14 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K152884 | DermaTherapy Bed Linens | Jun 20, 2016 | Substantially Equivalent | Precision Fabrics Group, Inc. |
| K061242 | DERMATHERAPY, MODEL 22216 | Jan 25, 2007 | Substantially Equivalent | Precision Fabrics Group, Inc. |
| K001003 | Z-NET | Dec 10, 2001 | Substantially Equivalent | Demite Limited |
| K992702 | EVENT ALLERGEN BARRIERS, EVENT MATTRESS ENCASING, EVENT DUVET ENCASING, EVENT PILLOW ENCASING, EVENT BEDDING SYSTEM | Nov 08, 1999 | Substantially Equivalent | Allergy Direct |
| K940327 | INTERVENT ALLERGEN EXCLUSION TECHNOLOGY, INTERVENT BEDDING SYSTEM, INTERVENT MATTRESS INTERLINER, INTERVIEW PILLOW | Feb 25, 1994 | Substantially Equivalent | W. L. Gore & Associates, Inc. |
| K935220 | CORE PREVENT MATTRESS MODIFICATION | Nov 29, 1993 | Substantially Equivalent | Paladin Medical, Inc. |
| K924807 | REUSABLE INCONTIENT UNDERPAD | Feb 10, 1993 | Substantially Equivalent | Perfect Fit Industries, Inc. |
| K924477 | WIPEABLE PILLOW | Jan 29, 1993 | Substantially Equivalent | Perfect Fit Industries, Inc. |
| K923173 | OBALON COVER | Nov 06, 1992 | Substantially Equivalent | Turnsoft, Inc. |
| K921928 | SOFT-COVER | Nov 06, 1992 | Substantially Equivalent | Adroit Medical Systems, Inc. |
| K903382 | ALLERGY CONTROL COVERS | Nov 02, 1990 | Substantially Equivalent | Allergy Control Products, Inc. |
| K902446 | DISPOSABLE STERILE TABLE TOP COVER FOR HYDRADJUST | Aug 10, 1990 | Substantially Equivalent | Mallinckrodt Group, Inc. |
| K832483 | MATTRESS COVER, ANTI-MICROBIAL | Feb 04, 1984 | Substantially Equivalent | American Threshold Industries, Inc. |
| K780033 | MATTRESSES, CONDUCTIVE & COVERS | Feb 21, 1978 | Substantially Equivalent | Chase Mfg. Co. |
FEI Numbers
This FDA classification entry is associated with 210 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 210 registration numbers. Click on an entry to view related FDA registrations.