Non-Sterile Isolation Gown
FDA 510(k) K970814 · American Seal Co.
510(k) numberK970814
Submission
- Device name
- Non-Sterile Isolation Gown
- Applicant
- American Seal Co.
Hayward, CA, US - Received
- March 6, 1997
- Decision date
- May 27, 1997
- 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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
More from Wuhan Dymex Healthcare Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K972227 | Shoe CoverFYF · Traditional | 09/09/1997SE |
| K972187 | Bouffant CapKKX · Traditional | 09/09/1997SE |
| K964358 | Amseal Surgical Face MaskFXX · Traditional | 02/14/1997SE |
| K892557 | Maytex Non-Sterile Latex Exam GloveLYY · Traditional | 05/31/1989SE |
| K892553 | Maytex Patient Examination GlovesLYY · Traditional | 05/25/1989SE |
Questions and answers
When was Non-Sterile Isolation Gown cleared by the FDA?
Non-Sterile Isolation Gown (K970814) received a 510(k) decision of Substantially Equivalent on May 27, 1997, 82 days after the submission was received.
What is the product code of K970814?
The FDA product code is FYC – Gown, Isolation, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.4040.