Isolation Gown AAMI Level 3— 510(k) K212504
Substantially EquivalentKenpax International Limited
FDA 510(k) clearance K212504 for Isolation Gown AAMI Level 3, Substantially Equivalent on 2021-11-07. Applicant: Kenpax International Limited. Device class: 2.
Clearance details
- Applicant
- Kenpax International Limited
- 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
- Hong Kong, CN
Recent devices under product code FYC
view all- K232849 — Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311)
- K230135 — Copioumed Chemotherapy Isolation Gown
- K223467 — Disposable Isolation Gown
- K223304 — Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)
- K223411 — Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)
More clearances from Kenpax International Limited
view allData sourced from openFDA. This site is unofficial and independent of the FDA.