Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311)
FDA 510(k) K232849 · Owens & Minor (O&M) Halyard, Inc.
510(k) numberK232849
Submission
- Device name
- Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311)
- Applicant
- Owens & Minor (O&M) Halyard, Inc.
Mechanicsville, VA, US - Received
- September 14, 2023
- Decision date
- May 16, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FYC – Gown, Isolation, Surgical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4040
- Specialty
- General, Plastic Surgery
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K230135 | Copioumed Chemotherapy Isolation GownFYC · Traditional | Copioumed International, Inc. | 10/04/2023SE |
| K223467 | Disposable Isolation GownFYC · Traditional | Nanning Tecbod Biological Technology Co., Ltd. | 02/10/2023SE |
| K223304 | Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)FYC · Traditional | Xiamen Probtain Medical Technology Co., Ltd. | 02/08/2023SE |
| K223411 | Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)FYC · Traditional | Xiamen Probtain Medical Techology Co., Ltd. | 01/04/2023SE |
| K212717 | Paneffort AAMI Level 3 Isolation GownFYC · Traditional | Paneffort, LLC | 11/30/2022SE |
| K210414 | CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with…FYC · Traditional | Medtecs (Taiwan) Corp. | 10/21/2022SE |
| K214116 | AAMI4 Isolation GownFYC · Traditional | Hubei Xinxin Non-Woven Co., Ltd. | 10/11/2022SE |
| K221027 | Isolation Gown (S, M, L, XL, XXL (Yellow, Blue))FYC · Traditional | Allmed Medical (Hubei) Protective Products Co.… | 08/12/2022SE |
| K220528 | Surgical Isolation Cover GownFYC · Traditional | Wuhan Dymex Healthcare Co., Ltd. | 06/10/2022SE |
| K213832 | AAMI3 Isolation GownFYC · Traditional | Hubei Xinxin Non-Woven Co., Ltd. | 05/16/2022SE |
More from Hubei Xinxin Non-Woven Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K243010 | Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804)…FXX · Abbreviated | 05/30/2025SE |
| K232824 | FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White…FXX · Traditional | 07/02/2024SE |
| K232777 | FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender…FXX · Traditional | 07/01/2024SE |
| K232807 | Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869)…FXX · Traditional | 06/21/2024SE |
| K232812 | Fluidshield* 2 Fog-Free Surgical Mask (62113); Fluidshield* 2 Fog-Free Surgical Mask…FXX · Traditional | 06/14/2024SE |
| K232806 | HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867)…FXX · Traditional | 06/07/2024SE |
| K232820 | HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806)FXX · Traditional | 06/04/2024SE |
| K233022 | Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft…MSH · Traditional | 01/12/2024SE |
| K232894 | HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining…FXX · Traditional | 01/08/2024SE |
| K214007 | HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization WrapFRG · Traditional | 07/27/2022SE |
Questions and answers
When was Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311) cleared by the FDA?
Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311) (K232849) received a 510(k) decision of Substantially Equivalent on May 16, 2024, 245 days after the submission was received.
What is the product code of K232849?
The FDA product code is FYC – Gown, Isolation, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.4040.