Cotton, Roll
FDA product code EFN · Class I (low risk) · 21 CFR 872.6050 · Dental
14510(k) clearances
0PMA approvals
2recalls
GMP exemptexempt from GMP rules
Manufacturers
- Intl. Verbandstoff-Fabrik Schaffhau 2
- Lorvic Corp. 1
- Parker Laboratories, Inc. 1
- Worldwide Surgical Gauze 1
- Hoyt Laboratories 1
- Medspec Corp. 1
- Veratex Corp. 1
- Henry Schein, Inc. 1
- Molnlycke A/S Hospital Products 1
- Cross Country Paper Products Corp. 1
- The Medical Group, Inc. 1
- Medgroup Enterprises, Inc. 1
- American Silk Sutures, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K872810 | Strung Dental RollsEFN · Traditional | American Silk Sutures, Inc. | 12/04/1987SE |
| K871464 | Medgroup Enterprises Cotton Gauze Sponges-Non SterEFN · Traditional | Medgroup Enterprises, Inc. | 04/30/1987SE |
| K863764 | Cotton Rolls, Non-SterileEFN · Traditional | The Medical Group, Inc. | 10/27/1986SE |
| K861338 | Dental Cotton Rolls, Sterile and Non-SterileEFN · Traditional | Intl. Verbandstoff-Fabrik Schaffhau | 08/06/1986SE |
| K861727 | Cotton Filled Gauze Sponges 2 X 2EFN · Traditional | Cross Country Paper Products Corp. | 07/10/1986SE |
| K843539 | Teledyne Densco Dry Tips Saliva Absorb-EFN · Traditional | Molnlycke A/S Hospital Products | 05/23/1985SE |
| K841327 | Dental Cotton RollsEFN · Traditional | Intl. Verbandstoff-Fabrik Schaffhau | 07/03/1984SE |
| K834056 | Schein Cotton Rolls, Non-SterileEFN · Traditional | Henry Schein, Inc. | 02/03/1984SE |
| K830175 | Sterile Cotton Rolls #3, 1 1/2EFN · Traditional | Veratex Corp. | 02/18/1983SE |
| K812709 | Sterile Dental RollEFN · Traditional | Medspec Corp. | 10/23/1981SE |
| K810830 | Hoyt Cotton RollsEFN · Traditional | Hoyt Laboratories | 04/14/1981SE |
| K802429 | Cotton RollsEFN · Traditional | Worldwide Surgical Gauze | 10/23/1980SE |
| K792391 | Cotton Roll Compression CapsEFN · Traditional | Parker Laboratories, Inc. | 12/06/1979SE |
| K770063 | Disp. Absorbent Compressed Fibre WaferEFN · Traditional | Lorvic Corp. | 01/14/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1747-2022 Class II | FABCO ORS DENTAL ROLLS, 1-1/2" STERILE, COTTON 3/8" Diameter x 1-1/2" (9.5mm x 38.1mm)…Sterility with new cotton source not validated | Carwild Corporation | 08/02/2022Open, Classified |
| Z-1799-2016 Class II | American Surgical Cylindrical Sponges-Strung 1/2" x 1.5" Ref Number: 70-02 Product…Product packaging defective compromising sterility | American Surgical Company | 03/31/2016Terminated |