Non-sterile Level 3 Surgical Gown (4025) +3 more— 510(k) K253003
Substantially EquivalentHubei Xinxin Non-Woven Co., Ltd.
FDA 510(k) clearance K253003 for Non-sterile Level 3 Surgical Gown (4025) +3 more, Substantially Equivalent on 2026-04-20. Applicant: Hubei Xinxin Non-Woven Co., Ltd.. Device class: 2.
Clearance details
- Device name as filed
- Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025); Non-sterile Reinforced Level 4 Surgical Gown (G4025); Reinforced Sterile Level 4 Surgical Gown (GM4025)
- Applicant
- Hubei Xinxin Non-Woven 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
- Xiantao, CN
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More clearances from Hubei Xinxin Non-Woven Co., Ltd.
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