ComfortGuard Surgical Isolation Gown
FDA 510(k) K210131 · Gri-Alleset, Inc.
510(k) numberK210131
Submission
- Device name
- ComfortGuard Surgical Isolation Gown
- Applicant
- Gri-Alleset, Inc.
Flowery Branch, GA, US - Received
- January 19, 2021
- Decision date
- August 26, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
Other 510(k)s with product code FYC
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|---|---|---|---|
| K232849 | Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3…FYC · Abbreviated | Owens & Minor (O&M) Halyard, Inc. | 05/16/2024SE |
| 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 |
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| K242664 | gentleheel® Adult Incision DeviceFMK · Traditional | 11/05/2024SE |
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| K210860 | Comfort Guard Mask, level 1, Comfort Guard Mask, level 3FXX · Traditional | 04/07/2022SE |
Questions and answers
When was ComfortGuard Surgical Isolation Gown cleared by the FDA?
ComfortGuard Surgical Isolation Gown (K210131) received a 510(k) decision of Substantially Equivalent on August 26, 2021, 219 days after the submission was received.
What is the product code of K210131?
The FDA product code is FYC – Gown, Isolation, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.4040.