Submission Details
| 510(k) Number | K202447 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 26, 2020 |
| Decision Date | April 02, 2021 |
| Days to Decision | 219 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
Cleared
Traditional
Medline Orbis Surgical Gown
Apr 2021
Decision
219d
Days
Class 2
Risk
About This 510(k) Submission
K202447 is an FDA 510(k) clearance for the Medline Orbis Surgical Gown, a Gown, Surgical (Class II — Special Controls, product code FYA), submitted by Medline Industries, Inc. (Nortfield, US). The FDA issued a Cleared decision on April 2, 2021, 219 days after receiving the submission on August 26, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.
Device Classification
| Product Code | FYA — Gown, Surgical |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4040 |
Manufacturer
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