FYC — Gown, Isolation, Surgical Class II
FDA product code FYC covers "Gown, Isolation, Surgical", a Class II medical device regulated under 21 CFR 878.4040. Submissions are reviewed by the General, Plastic Surgery panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FYC
- Device Class
- Class II
- Regulation Number
- 878.4040
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K232849 | owens and minor (o and m) halyard | Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI | May 16, 2024 |
| K230135 | copioumed international | Copioumed Chemotherapy Isolation Gown | October 4, 2023 |
| K223467 | nanning tecbod biological technology co | Disposable Isolation Gown | February 10, 2023 |
| K223304 | xiamen probtain medical technology co | Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) | February 8, 2023 |
| K223411 | xiamen probtain medical techology co | Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) | January 4, 2023 |
| K212717 | paneffort | Paneffort AAMI Level 3 Isolation Gown | November 30, 2022 |
| K210414 | medtecs (taiwan) | CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable G | October 21, 2022 |
| K214116 | hubei xinxin non-woven co | AAMI4 Isolation Gown | October 11, 2022 |
| K221027 | allmed medical (hubei) protective products co | Isolation Gown (S, M, L, XL, XXL (Yellow, Blue)) | August 12, 2022 |
| K220528 | wuhan dymex healthcare co | Surgical Isolation Cover Gown | June 10, 2022 |
| K213832 | hubei xinxin non-woven co | AAMI3 Isolation Gown | May 16, 2022 |
| K212422 | crown name disposable hygiene products fty | Disposable Surgical Isolation Gown | April 29, 2022 |
| K210148 | flomak tekstil makine muh. mum. taah. san. tic. ltd. sti | Flosteril Poly-reinforced Isolation Gowns Model 8120 (Catalogue Number 8120400), | April 13, 2022 |
| K212698 | foshan nanhai plus medical co | Plus Medical Isolation Gown Level 3 | March 2, 2022 |
| K212357 | wuhan zonsen medical products co | Surgical isolation gown | January 20, 2022 |
| K212633 | string king lacrosse | Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Lev | November 24, 2021 |
| K211538 | azac group | Protect X Level 3 Isolation Gown | November 17, 2021 |
| K210785 | chongqing litai fashion group limited | Disposable Surgical Gowns | November 13, 2021 |
| K212504 | kenpax international limited | Isolation Gown AAMI Level 3 | November 7, 2021 |
| K210131 | gri-alleset | ComfortGuard Surgical Isolation Gown | August 26, 2021 |