Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80)
FDA 510(k) clearance K222266 · decided 2022-09-26
Clearance details
- K-number
- K222266
- Device name
- Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80)
- Applicant
- Jingzhou Haixin Green Cross Medical Products Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2022-07-28
- Decision date
- 2022-09-26
- Days to decision
- 60 days
- Clearance type
- Traditional
- Product code
- FXX
- Device class
- 2
- Regulation number
- 878.4040
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Jingzhou, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.