Isosafe Earloop Procedure Mask (Blue, Yellow)
FDA 510(k) K972849 · Cypress Medical Products, Ltd.
510(k) numberK972849
Submission
- Device name
- Isosafe Earloop Procedure Mask (Blue, Yellow)
- Applicant
- Cypress Medical Products, Ltd.
Mc Henry, IL, US - Received
- August 1, 1997
- Decision date
- May 28, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FXX – Mask, Surgical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4040
- Specialty
- General, Plastic Surgery
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| K251967 | HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT*…FXX · Traditional | O&M Halyard, Inc. | 03/18/2026SE |
| K252534 | Surgical Face Mask (Ear mount)FXX · Traditional | Zhejiang Hangkang Medical Equipment Co., Ltd. | 03/03/2026SE |
| K253398 | Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)FXX · Special | Efofex, Inc. | 02/19/2026SE |
| K252830 | Disposable Surgical Face Mask (3P00B, C2900)FXX · Traditional | Beatles Medical Supplies (Xiantao) Co., Ltd. | 01/12/2026SE |
| K252650 | Disposable Medical Face MaskFXX · Traditional | Makrite Industries, Inc. | 01/05/2026SE |
| K243342 | KP Protective Face MaskFXX · Traditional | Kp Trading Co., Ltd. | 12/22/2025SE |
| K252941 | HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* EarloopsFXX · Traditional | O&M Halyard, Inc. | 12/11/2025SE |
| K252964 | PRIMED Surgical and Procedure MasksFXX · Traditional | Primed Medical Products, Inc. | 11/04/2025SE |
| K251902 | Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with Shield…FXX · Traditional | Vitacore Industries, Inc. | 09/17/2025SE |
| K250082 | Procedure mask/Surgical mask/Face maskFXX · Traditional | Winner Medical Co., Ltd. | 06/18/2025SE |
More from Winner Medical Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K021676 | Cypress Medical Products, LP Disposable Vaginal Speculum, Non-MetalHIB · Traditional | 07/12/2002SE |
| K012282 | Sterile Powder Free Synthetic Vinyl Patient Exam GloveLYZ · Traditional | 08/06/2001SE |
| K972899 | Cypress Medical Products Aneroid SphygmomanometerDXQ · Traditional | 07/07/1998SE |
| K972883 | Isosafe Earloop Procedure Mask (Blue, Yellow)FXX · Traditional | 02/26/1998SE |
| K952367 | Cypress Medical Products Vinyl Examination GloveLYY · Traditional | 07/05/1995SE |
| K950254 | Cypress Medical Products Sterile Latex Examination GloveLYY · Traditional | 03/31/1995SE |
| K950109 | Cypress Medical Products Catheter (Insertion) Tray/With Out CatheterFCM · Traditional | 02/27/1995SESK |
| K950092 | Cypress Medical Products Catheter (Insertion) TrayFCM · Traditional | 02/27/1995SESK |
| K945082 | Cypress Medical Products StethoscopeLDE · Traditional | 12/08/1994SE |
| K921988 | Laceration Repair TrayMDM · Traditional | 11/19/1992SEKD |
Questions and answers
When was Isosafe Earloop Procedure Mask (Blue, Yellow) cleared by the FDA?
Isosafe Earloop Procedure Mask (Blue, Yellow) (K972849) received a 510(k) decision of Substantially Equivalent on May 28, 1998, 300 days after the submission was received.
What is the product code of K972849?
The FDA product code is FXX – Mask, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.4040.