FME · Gown, Examination
General Hospital · 21 CFR 880.6265 · Class 1
Overview
| Product Code | FME |
|---|---|
| Device Name | Gown, Examination |
| Regulation | 21 CFR 880.6265 |
| Device Class | Class 1 |
| Review Panel | General Hospital |
| GMP Exempt | Yes |
Identification
An examination gown is a device intended for medical purposes that is made of cloth, paper, or other material that is draped over or worn by a patient as a body covering during a medical examination.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. If the device is not labeled or otherwise represented as sterile, it is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K880385 | KIMBERLY-CLARK PROFESSIONAL JACKET | Kimberly-Clark Corp. | Feb 19, 1988 | SESE |
| K811915 | MONITOR/VITAL SIGNS TRAY | American Hospital Supply Corp. | Jul 28, 1981 | SESE |
| K770476 | EXAM GOWN | General Medical Co. | May 6, 1977 | SESE |
| K760954 | CROWNTEX EXAM. CAPE & GOWN | Graham Manufacturing Co. | Dec 30, 1976 | SESE |
| K760360 | SHIRT, MITTEN CUFF INFANT | Precept, Inc. | Oct 20, 1976 | SESE |
Top Applicants
- American Hospital Supply Corp. — 1 clearance
- General Medical Co. — 1 clearance
- Graham Manufacturing Co. — 1 clearance
- Kimberly-Clark Corp. — 1 clearance
- Precept, Inc. — 1 clearance
