Submission Details
| 510(k) Number | K223304 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 27, 2022 |
| Decision Date | February 08, 2023 |
| Days to Decision | 104 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)
Feb 2023
Decision
104d
Days
Class 2
Risk
About This 510(k) Submission
K223304 is an FDA 510(k) clearance for the Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL), a Gown, Isolation, Surgical (Class II — Special Controls, product code FYC), submitted by Xiamen Probtain Medical Technology Co., Ltd. (Xiamen, CN). The FDA issued a Cleared decision on February 8, 2023, 104 days after receiving the submission on October 27, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.
Device Classification
| Product Code | FYC — Gown, Isolation, Surgical |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4040 |
Manufacturer
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