Gown, Examination
The Examination Gown is a disposable or reusable garment worn by patients during medical examinations to provide modesty and access to the body for examination. It is classified as FDA Class 1 (lowest risk) and is subject only to general controls. The product code is FME, regulated under 21 CFR 880.6265 in the General Hospital specialty. This device is exempt from Good Manufacturing Practice (GMP) requirements.
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Basic Information
- Product Code
- FME
- Device Class
- FDA class 1
- Regulation Number
- 880.6265
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K880385 | KIMBERLY-CLARK PROFESSIONAL JACKET | Feb 19, 1988 | Substantially Equivalent | Kimberly-Clark Corp. |
| K811915 | MONITOR/VITAL SIGNS TRAY | Jul 28, 1981 | Substantially Equivalent | American Hospital Supply Corp. |
| K770476 | EXAM GOWN | May 06, 1977 | Substantially Equivalent | General Medical Co. |
| K760954 | CROWNTEX EXAM. CAPE & GOWN | Dec 30, 1976 | Substantially Equivalent | Graham Manufacturing Co. |
| K760360 | SHIRT, MITTEN CUFF INFANT | Oct 20, 1976 | Substantially Equivalent | Precept, Inc. |
FEI Numbers
This FDA classification entry is associated with 234 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 234 registration numbers. Click on an entry to view related FDA registrations.