Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL)— 510(k) K230577
Substantially EquivalentMedcare Saglik Urunleri Sanayi VE Ticaret Anonim Sirketi
FDA 510(k) clearance K230577 for Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL), Substantially Equivalent on 2023-08-16. Applicant: Medcare Saglik Urunleri Sanayi VE Ticaret Anonim Sirketi. Device class: 2.
Clearance details
- Applicant
- Medcare Saglik Urunleri Sanayi VE Ticaret Anonim Sirketi
- Product code
- Code FYA
- 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
- Izmir, TR
Recent devices under product code FYA
view all- K260407 — Principle & Will ANSI/AAMI PB 70 (Sterile/Non-sterile) Level 3 Surgical Gowns (Reinforced) and Principle & Will ANSI/AMMI PB70 (Sterile/Non-sterile) Level 4 Surgical Gowns/Isolation Gowns
- K261028 — Surgical Gown Level2 (S, M, L, XL, XXL, XXXL)
- K261949 — NYES Tuff Cuff L3 Disposable Gowns
- K252575 — Tuff Cuff Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)
- K260725 — BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)
Data sourced from openFDA. This site is unofficial and independent of the FDA.