Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)— 510(k) K223411
Substantially EquivalentXiamen Probtain Medical Techology Co., Ltd.
FDA 510(k) clearance K223411 for Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL), Substantially Equivalent on 2023-01-04. Applicant: Xiamen Probtain Medical Techology Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Xiamen Probtain Medical Techology Co., Ltd.
- Product code
- Code FYC
- Device class
- Class 2
- Regulation
- 21 CFR 878.4040
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Xiamen, CN
Recent devices under product code FYC
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- K223467 — Disposable Isolation Gown
- K223304 — Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)
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More clearances from Xiamen Probtain Medical Techology Co., Ltd.
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