Product Code: FYB
FDA class 2
21 CFR 878.4040
Gown, Patient
General, Plastic Surgery
A patient gown is a garment worn by patients in clinical and hospital settings to provide access for examination and treatment while maintaining patient comfort and modesty. It is classified as FDA Class 2 (moderate risk), subject to general and special controls, and requires 510(k) premarket notification. The product code is FYB, regulated under 21 CFR 878.4040, within the General, Plastic Surgery medical specialty. This device is eligible for third-party 510(k) review.
510(k)s
6
FEI Numbers
0
Registration Numbers
0
Unique Applicants
6
Years Active
13
Basic Information
- Product Code
- FYB
- Device Class
- FDA class 2
- Regulation Number
- 878.4040
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✓
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K911921 | DISPOSABLE ISOLATION GOWN | May 13, 1991 | Substantially Equivalent | Liaoning-Usa Corp. |
| K891820 | DISPOSABLE MEDICAL GOWNS | Jul 24, 1989 | Substantially Equivalent | Bioshield, Inc. |
| K891053 | DENTAL BIB | Apr 12, 1989 | Substantially Equivalent | Dispomed, Inc. |
| K803171 | PROCEDURE & RECOVERY PATIENT SUIT | Mar 04, 1981 | Substantially Equivalent | Alba Health Care |
| K801570 | SHIELD DISP. PATIENTS PONCHO GOWNS | Jul 28, 1980 | Substantially Equivalent | American Convertors Div., American Pharmaseal |
| K771929 | PEDIATRICS GOWN | Nov 16, 1977 | Substantially Equivalent | Convertors |