FYB
6 FDA 510(k) clearances · Product code
44 daysmedian time to decision
126 days90th percentile
6clearances measured
FDA profile
- Official device name
- Gown, Patient
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4040
- Medical specialty
- General, Plastic Surgery
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 2003: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| DISPOSABLE ISOLATION GOWN (K911921) | Liaoning-Usa Corp. | 1991-05-13 |
| DISPOSABLE MEDICAL GOWNS (K891820) | Bioshield, Inc. | 1989-07-24 |
| DENTAL BIB (K891053) | Dispomed, Inc. | 1989-04-12 |
| PROCEDURE & RECOVERY PATIENT SUIT (K803171) | Alba Health Care | 1981-03-04 |
| SHIELD DISP. PATIENTS PONCHO GOWNS (K801570) | American Convertors Div., American Pharmaseal | 1980-07-28 |
| PEDIATRICS GOWN (K771929) | Convertors | 1977-11-16 |
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Every clearance here is in the API, with alerts when new ones post.