FRL · Fiber, Medical, Absorbent
General Hospital · 21 CFR 880.5300 · Class 1
Overview
| Product Code | FRL |
|---|---|
| Device Name | Fiber, Medical, Absorbent |
| Regulation | 21 CFR 880.5300 |
| Device Class | Class 1 |
| Review Panel | General Hospital |
| GMP Exempt | Yes |
Identification
A medical absorbent fiber is a device intended for medical purposes that is made from cotton or synthetic fiber in the shape of a ball or a pad and that is used for applying medication to, or absorbing small amounts of body fluids from, a patient's body surface. Absorbent fibers intended solely for cosmetic purposes are not included in this generic device category.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. If the device is not labeled or otherwise represented as sterile, it is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (19 of 19)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K121898 | STAY FRESH SKIN FOLD MANAGEMENT TEXTILE | Quick-Med Technologies, Inc. | May 24, 2013 | SESE |
| K110715 | INTERDRY SILVER | Milliken Healthcare Products, LLC | Nov 4, 2011 | SESE |
| K061615 | INTERDRY TEXTILE WITH SILVER | Milliken Chemical | Dec 22, 2006 | SESE |
| K931626 | CARAPACE STERILE COTTON BALLS | Carapace, Inc. | Dec 2, 1993 | SESE |
| K914081 | ICAN COTTON RAYON BALLS | Icn Pharmaceuticals, Inc. | Oct 9, 1991 | SESE |
| K811990 | TRACH CLEANING TRAY | Associated Medical Products Co. | Jul 27, 1981 | SESE |
| K810242 | UTENSIL & PROCEDURE TRAYS | American Hospital Supply Corp. | Apr 15, 1981 | SESE |
| K800277 | MEDSPEC RAYON BALLS | Medspec Corp. | Mar 12, 1980 | SESE |
| K800249 | SURGITEK FOERSTER MAMMARY BANDAGE | Medical Engineering Corp. | Feb 19, 1980 | SESE |
| K800248 | SURGITEK FOERSTER FACE LIFT BANDAGE | Medical Engineering Corp. | Feb 19, 1980 | SESE |
| K792295 | SORBIES | American Hospital Supply Corp. | Dec 20, 1979 | SESE |
| K792294 | BREAST PAD | American Hospital Supply Corp. | Dec 11, 1979 | SESE |
| K791167 | DEXIDE DISPOSABLE PREP PAD | Dexide, Inc. | Aug 3, 1979 | SESE |
| K780974 | BACILLUS PUMILUS | Urol, Inc. | Jul 27, 1978 | SESE |
| K771712 | CATHETER DRESSING CHANCE SET | Shield Laboratories, Inc. | Oct 13, 1977 | SESE |
| K771551 | I.V. PREP & CARE KIT | Jelco Laboratories | Oct 4, 1977 | SESE |
| K770853 | STERILE COTTON | Stat Medical Corp. | May 23, 1977 | SESE |
| K770588 | COTTON BALL KIT | American Hospital Supply Corp. | May 23, 1977 | SESE |
| K761099 | DOVER HYPERALIMENTATION DRESSING CHNG KT | Will Ross Co. | Jan 28, 1977 | SESE |
Top Applicants
- American Hospital Supply Corp. — 4 clearances
- Medical Engineering Corp. — 2 clearances
- Associated Medical Products Co. — 1 clearance
- Carapace, Inc. — 1 clearance
- Dexide, Inc. — 1 clearance
