510(k) K203539
K203539 is an FDA 510(k) premarket notification submitted by Unicoglobal, Inc. for the device "Unico Global level 3 Surgical Gown (Film-reinforced SMS), Unico Global Level 3 Surgical Gown (PP+PE)". The FDA issued a decision of Substantially Equivalent on Dec 10, 2021. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040. Unicoglobal, Inc. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 10, 2021
- Date Received
- Dec 3, 2020
- 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
- 510(k)