FDA product code FYB: Gown, Patient
FYB is the FDA product code for gown, patient. It is a Class II device, regulated under 21 CFR 878.4040 and reviewed by the General Hospital panel. FDA has cleared 6 510(k) submissions under FYB, from 6 different applicants. The average 510(k) review took 52 days (median 38).
Classification
| Field | Value |
|---|---|
| Device name | Gown, Patient |
| Device class | Class II |
| Regulation | 21 CFR 878.4040 |
| Review panel | HO — General Hospital |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every FYB clearance
Top FYB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Liaoning-Usa Corp. | 1 | 1991-05-13 |
| Bioshield, Inc. | 1 | 1989-07-24 |
| Dispomed, Inc. | 1 | 1989-04-12 |
| Alba Health Care | 1 | 1981-03-04 |
| American Convertors Div., American Pharmaseal | 1 | 1980-07-28 |
1 more applicants have FYB clearances. See the full list in Caduvo.
Most recent FYB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K911921 | Liaoning-Usa Corp. | DISPOSABLE ISOLATION GOWN | 1991-05-13 | 13 |
| K891820 | Bioshield, Inc. | DISPOSABLE MEDICAL GOWNS | 1989-07-24 | 126 |
| K891053 | Dispomed, Inc. | DENTAL BIB | 1989-04-12 | 44 |
| K803171 | Alba Health Care | PROCEDURE & RECOVERY PATIENT SUIT | 1981-03-04 | 79 |
| K801570 | American Convertors Div., American Pharmaseal | SHIELD DISP. PATIENTS PONCHO GOWNS | 1980-07-28 | 20 |
Recalls for FYB devices
openFDA lists no recalls for product code FYB.
Frequently asked questions
What is FDA product code FYB?
FYB is the FDA product code for gown, patient. It is a Class II device, regulated under 21 CFR 878.4040 and reviewed by the General Hospital panel.
What device class is FYB?
Class II, regulation 21 CFR 878.4040. Typical premarket route: 510(k).
How long does a 510(k) take for product code FYB?
Across 6 cleared submissions the average was 52 days from receipt to decision (median 38).
Which companies have the most FYB clearances?
Liaoning-Usa Corp. (1); Bioshield, Inc. (1); Dispomed, Inc. (1); Alba Health Care (1); American Convertors Div., American Pharmaseal (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FYB
- Run a recall and safety report across every FYB manufacturer
- Watch product code FYB for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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