Fiber, Medical, Absorbent
Medical absorbent fiber is a material used in wound care and other clinical applications to absorb fluids such as blood or exudate, contributing to wound management and patient hygiene. It is classified as FDA Class 1 (lowest risk), subject to general controls only, and does not require premarket notification. The product code is FRL, regulated under 21 CFR 880.5300, within the General Hospital medical specialty. This device is exempt from GMP requirements.
Basic Information
- Product Code
- FRL
- Device Class
- FDA class 1
- Regulation Number
- 880.5300
- 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 19 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K121898 | STAY FRESH SKIN FOLD MANAGEMENT TEXTILE | May 24, 2013 | Substantially Equivalent | Quick-Med Technologies, Inc. |
| K110715 | INTERDRY SILVER | Nov 04, 2011 | Substantially Equivalent | Milliken Healthcare Products, LLC |
| K061615 | INTERDRY TEXTILE WITH SILVER | Dec 22, 2006 | Substantially Equivalent | Milliken Chemical |
| K931626 | CARAPACE STERILE COTTON BALLS | Dec 02, 1993 | Substantially Equivalent | Carapace, Inc. |
| K914081 | ICAN COTTON RAYON BALLS | Oct 09, 1991 | Substantially Equivalent | Icn Pharmaceuticals, Inc. |
| K811990 | TRACH CLEANING TRAY | Jul 27, 1981 | Substantially Equivalent | Associated Medical Products Co. |
| K810242 | UTENSIL & PROCEDURE TRAYS | Apr 15, 1981 | Substantially Equivalent | American Hospital Supply Corp. |
| K800277 | MEDSPEC RAYON BALLS | Mar 12, 1980 | Substantially Equivalent | Medspec Corp. |
| K800249 | SURGITEK FOERSTER MAMMARY BANDAGE | Feb 19, 1980 | Substantially Equivalent | Medical Engineering Corp. |
| K800248 | SURGITEK FOERSTER FACE LIFT BANDAGE | Feb 19, 1980 | Substantially Equivalent | Medical Engineering Corp. |
| K792295 | SORBIES | Dec 20, 1979 | Substantially Equivalent | American Hospital Supply Corp. |
| K792294 | BREAST PAD | Dec 11, 1979 | Substantially Equivalent | American Hospital Supply Corp. |
| K791167 | DEXIDE DISPOSABLE PREP PAD | Aug 03, 1979 | Substantially Equivalent | Dexide, Inc. |
| K780974 | BACILLUS PUMILUS | Jul 27, 1978 | Substantially Equivalent | Urol, Inc. |
| K771712 | CATHETER DRESSING CHANCE SET | Oct 13, 1977 | Substantially Equivalent | Shield Laboratories, Inc. |
| K771551 | I.V. PREP & CARE KIT | Oct 04, 1977 | Substantially Equivalent | Jelco Laboratories |
| K770853 | STERILE COTTON | May 23, 1977 | Substantially Equivalent | Stat Medical Corp. |
| K770588 | COTTON BALL KIT | May 23, 1977 | Substantially Equivalent | American Hospital Supply Corp. |
| K761099 | DOVER HYPERALIMENTATION DRESSING CHNG KT | Jan 28, 1977 | Substantially Equivalent | Will Ross Co. |
FEI Numbers
This FDA classification entry is associated with 391 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 392 registration numbers. Click on an entry to view related FDA registrations.