Disposable Beard Cover
FDA 510(k) K904276 · Anago, Inc.
510(k) numberK904276
Submission
- Device name
- Disposable Beard Cover
- Applicant
- Anago, Inc.
Fort Worth, TX, US - Received
- September 19, 1990
- Decision date
- November 21, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FXY – Hood, Surgical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4040
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code FXY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K222214 | ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood)FXY · Traditional | Thi Total Healthcare Innovation GmbH | 10/17/2023SE |
| K200493 | Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical…FXY · Traditional | Stryker Corporation | 03/21/2020SE |
| K140588 | Flyte Hybrid Hood, Flyte Hybrid Hood with Peelaway LensFXY · Special | Stryker Corporation | 06/26/2014SE |
| K904969 | Hood, Operating, SurgicalFXY · Traditional | Chicago Assoc. For Retarded Citizens | 12/12/1990SE |
| K903533 | Steri-ShieldFXY · Traditional | Biomedical Devices, Inc. | 10/19/1990SE |
| K902677 | Steri-ShieldFXY · Traditional | Biomedical Devices, Inc. | 08/17/1990SE |
| K880431 | Caretex Surgeon's HoodsFXY · Traditional | James River Corp. | 02/24/1988SE |
| K770261 | Hood, Clarion SurgeonsFXY · Traditional | Sherwood Medical Industries | 03/01/1977SE |
| K770257 | Hood & Beard Cover, Clarion Surgeon'sFXY · Traditional | Sherwood Medical Industries | 02/25/1977SE |
| K761070 | P.S.M. Surgical HoodFXY · Traditional | The Owenby Co. | 12/30/1976SE |
More from The Owenby Co.
| 510(k) | Device | Decision |
|---|---|---|
| K925659 | U.C.E.Z. Lens Cleaner KitOCT · Traditional | 09/17/1993SE |
| K930161 | Anago Spinal Anesthesia TrayCAZ · Traditional | 07/06/1993SEKD |
| K926590 | Anago Disposable Instant Cold PackIMD · Traditional | 05/26/1993SE |
| K926589 | Anago Warm PackIMD · Traditional | 05/26/1993SE |
| K926137 | Anago Fem-Cool/Fem-Cool PetiteIMD · Traditional | 05/26/1993SE |
| K920615 | Anago Continuous Epidural Anesthesia Tray/KitCAZ · Traditional | 03/20/1993SEKD |
| K915415 | Guardall ShieldLYU · Traditional | 10/15/1992SE |
| K913558 | Reliable Cone Style Face MaskFXX · Traditional | 11/07/1991SE |
| K905865 | Anti-For Surgical Face MaskFXX · Traditional | 03/06/1991SE |
| K905749 | Surgical Face MaskFXX · Traditional | 03/04/1991SE |
Questions and answers
When was Disposable Beard Cover cleared by the FDA?
Disposable Beard Cover (K904276) received a 510(k) decision of Substantially Equivalent on November 21, 1990, 63 days after the submission was received.
What is the product code of K904276?
The FDA product code is FXY – Hood, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.4040.