Medical Device Manufacturer · CN , Xiantao

Hubei Xinxin Non-Woven Co., Ltd. - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2022
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Hubei Xinxin Non-Woven Co., Ltd. General Hospital ✕
4 devices
1-4 of 4
Cleared Apr 20, 2026
Non-sterile Level 3 Surgical Gown (4025)
K253003 · FYA
General Hospital · 213d
Cleared Oct 11, 2022
AAMI4 Isolation Gown
K214116 · FYC
General Hospital · 285d
Cleared May 16, 2022
AAMI3 Isolation Gown
K213832 · FYC
General Hospital · 158d
Cleared Jan 28, 2022
Surgical Masks
K212120 · FXX
General Hospital · 205d
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