Disposable Surgical Gown— 510(k) K214088
Substantially EquivalentWeihai Hongyu Nonwoven Fabric Products Co., Ltd.
FDA 510(k) clearance K214088 for Disposable Surgical Gown, Substantially Equivalent on 2022-04-12. Applicant: Weihai Hongyu Nonwoven Fabric Products Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Weihai Hongyu Nonwoven Fabric Products Co., Ltd.
- 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
- Weihai, CN
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)
More clearances from Weihai Hongyu Nonwoven Fabric Products Co., Ltd.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.