510(k) K221637
K221637 is an FDA 510(k) premarket notification submitted by Allmed Medical (Hubei) Protective Products Co., Ltd. for the device "Surgical Gown (Sterile); Surgical Gown (Non-sterile)". The FDA issued a decision of Substantially Equivalent on September 29, 2022. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040. Allmed Medical (Hubei) Protective Products Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 29, 2022
- Date Received
- June 6, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Gown, Surgical
- Device Class
- Class II
- Regulation Number
- 878.4040
- Review Panel
- HO
- Submission Type