Product code FRL
- Device name
- Fiber, Medical, Absorbent
- Medical specialty
- General Hospital
- Device class
- 1
- Regulation number
- 880.5300
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K121898 | STAY FRESH SKIN FOLD MANAGEMENT TEXTILE | Quick-Med Technologies, Inc. | 2013-05-24 |
| K110715 | INTERDRY SILVER | Milliken Healthcare Products, LLC | 2011-11-04 |
| K061615 | INTERDRY TEXTILE WITH SILVER | Milliken Chemical | 2006-12-22 |
| K931626 | CARAPACE STERILE COTTON BALLS | Carapace, Inc. | 1993-12-02 |
| K914081 | ICAN COTTON RAYON BALLS | Icn Pharmaceuticals, Inc. | 1991-10-09 |
| K811990 | TRACH CLEANING TRAY | Associated Medical Products Co. | 1981-07-27 |
| K810242 | UTENSIL & PROCEDURE TRAYS | American Hospital Supply Corp. | 1981-04-15 |
| K800277 | MEDSPEC RAYON BALLS | Medspec Corp. | 1980-03-12 |
| K800248 | SURGITEK FOERSTER FACE LIFT BANDAGE | Medical Engineering Corp. | 1980-02-19 |
| K800249 | SURGITEK FOERSTER MAMMARY BANDAGE | Medical Engineering Corp. | 1980-02-19 |
| K792295 | SORBIES | American Hospital Supply Corp. | 1979-12-20 |
| K792294 | BREAST PAD | American Hospital Supply Corp. | 1979-12-11 |
| K791167 | DEXIDE DISPOSABLE PREP PAD | Dexide, Inc. | 1979-08-03 |
| K780974 | BACILLUS PUMILUS | Urol, Inc. | 1978-07-27 |
| K771712 | CATHETER DRESSING CHANCE SET | Shield Laboratories, Inc. | 1977-10-13 |
| K771551 | I.V. PREP & CARE KIT | Jelco Laboratories | 1977-10-04 |
| K770588 | COTTON BALL KIT | American Hospital Supply Corp. | 1977-05-23 |
| K770853 | STERILE COTTON | Stat Medical Corp. | 1977-05-23 |
| K761099 | DOVER HYPERALIMENTATION DRESSING CHNG KT | Will Ross Co. | 1977-01-28 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10193489001907 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2025-08-06 |
| 10197106935132 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2025-02-24 |
| 10193489012521 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2024-10-24 |
| 10193489009460 | REMEDY | MEDLINE INDUSTRIES, INC. | 2024-10-24 |
| 10326053119450 | Regard™ | Resource Optimization & Innovation, L.L.C. | 2023-06-29 |
| 10326053119412 | Regard™ | Resource Optimization & Innovation, L.L.C. | 2023-06-14 |
| 10326053119429 | Regard™ | Resource Optimization & Innovation, L.L.C. | 2023-06-14 |
| 10326053119436 | Regard™ | Resource Optimization & Innovation, L.L.C. | 2023-06-14 |
| 10080196746248 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2022-12-17 |
| 10182921000448 | ALLCARE | ALLCARE, INC | 2022-07-09 |
| 10182921000233 | ALLCARE | ALLCARE, INC | 2022-06-05 |
| 10182921000134 | AllCare | ALLCARE, INC | 2022-04-06 |
| 10080196469451 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2022-01-01 |
| 10195594159405 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2021-07-29 |
| 10304040152079 | Henry Schein | HENRY SCHEIN, INC. | 2021-04-23 |
| 10304040152062 | Henry Schein | HENRY SCHEIN, INC. | 2021-04-23 |
| 10304040152055 | Henry Schein | HENRY SCHEIN, INC. | 2021-04-23 |
| 10304040152048 | Henry Schein | HENRY SCHEIN, INC. | 2021-04-23 |
| 10080196859580 | Medline | MEDLINE INDUSTRIES, INC. | 2021-03-31 |
| 10193489003581 | Medline | MEDLINE INDUSTRIES, INC. | 2021-03-22 |
| 10080196002139 | Medline | MEDLINE INDUSTRIES, INC. | 2021-01-26 |
| 10080196710744 | Medline | MEDLINE INDUSTRIES, INC. | 2021-01-26 |
| 10080196366972 | Medline | MEDLINE INDUSTRIES, INC. | 2021-01-21 |
| M220P7520233 | PRO ADVANTAGE | NATIONAL DISTRIBUTION & CONTRACTING, INC. | 2019-02-15 |
| M220P7530233 | PRO ADVANTAGE | NATIONAL DISTRIBUTION & CONTRACTING, INC. | 2019-02-15 |
| 10080196778584 | Medline | MEDLINE INDUSTRIES, INC. | 2016-10-14 |
| 10080196744329 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2016-10-14 |
| 10080196743414 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2016-10-14 |
| 10080196285549 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2016-10-14 |
| 10080196285518 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2016-10-14 |