Protectaide Personal Protection Pack No. 18000
FDA 510(k) K942474 · Protectaide, Inc.
510(k) numberK942474
Submission
- Device name
- Protectaide Personal Protection Pack No. 18000
- Applicant
- Protectaide, Inc.
Rockwall, TX, US - Received
- May 25, 1994
- Decision date
- October 18, 1994
- 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
Other 510(k)s with product code FXX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K942469 | Protectaide CPR Protection PackCBP · Traditional | 10/31/1994SE |
| K942468 | Protectaide CPR Protection Pack No. 22100CBP · Traditional | 10/31/1994SE |
| K942476 | Protectaide Biohazard Clean-Up Kit No. B3069FXX · Traditional | 10/18/1994SE |
| K942475 | Protectaide Personal Protection Pack No. 12351FXX · Traditional | 10/18/1994SE |
| K942473 | Protectaide Personal Protection Pack No. 24592FXX · Traditional | 10/18/1994SE |
| K942472 | Protectaide Personal Protection Pack No. 26123FXX · Traditional | 10/18/1994SE |
| K942471 | Protectaide Biohazard Clean-Up Kit No. 29777FXX · Traditional | 10/18/1994SE |
| K942470 | Protectaide Personal Protection Pack No. 08315FXX · Traditional | 10/18/1994SE |
| K942467 | Protectaide Aviator CPR Protection Pack No. 31000CBP · Traditional | 10/06/1994SE |
| K942466 | Protectaide CPR Protection Pack No. 17701CBP · Traditional | 10/06/1994SE |
Questions and answers
When was Protectaide Personal Protection Pack No. 18000 cleared by the FDA?
Protectaide Personal Protection Pack No. 18000 (K942474) received a 510(k) decision of Substantially Equivalent on October 18, 1994, 146 days after the submission was received.
What is the product code of K942474?
The FDA product code is FXX – Mask, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.4040.