AAMI4 Isolation Gown— 510(k) K214116
Substantially EquivalentHubei Xinxin Non-Woven Co., Ltd.
FDA 510(k) clearance K214116 for AAMI4 Isolation Gown, Substantially Equivalent on 2022-10-11. Applicant: Hubei Xinxin Non-Woven Co., Ltd..
Clearance details
- Applicant
- Hubei Xinxin Non-Woven Co., Ltd.
- Product code
- Code FYC
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Xiantao, CN
Data sourced from openFDA. This site is unofficial and independent of the FDA.