FDA product code FME: Gown, Examination
FME is the FDA product code for gown, examination. It is a Class I device, regulated under 21 CFR 880.6265 and reviewed by the General Hospital panel. FDA has cleared 5 510(k) submissions under FME, from 5 different applicants. The average 510(k) review took 48 days (median 56). FDA has posted 1 recall for FME devices.
Classification
| Field | Value |
|---|---|
| Device name | Gown, Examination |
| Device class | Class I |
| Regulation | 21 CFR 880.6265 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every FME clearance
Top FME applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kimberly-Clark Corp. | 1 | 1988-02-19 |
| American Hospital Supply Corp. | 1 | 1981-07-28 |
| General Medical Co. | 1 | 1977-05-06 |
| Graham Manufacturing Co. | 1 | 1976-12-30 |
| Precept, Inc. | 1 | 1976-10-20 |
Most recent FME clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K880385 | Kimberly-Clark Corp. | KIMBERLY-CLARK PROFESSIONAL JACKET | 1988-02-19 | 22 |
| K811915 | American Hospital Supply Corp. | MONITOR/VITAL SIGNS TRAY | 1981-07-28 | 27 |
| K770476 | General Medical Co. | EXAM GOWN | 1977-05-06 | 56 |
| K760954 | Graham Manufacturing Co. | CROWNTEX EXAM. CAPE & GOWN | 1976-12-30 | 58 |
| K760360 | Precept, Inc. | SHIRT, MITTEN CUFF INFANT | 1976-10-20 | 79 |
Recalls for FME devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2009-12-23.
Frequently asked questions
What is FDA product code FME?
FME is the FDA product code for gown, examination. It is a Class I device, regulated under 21 CFR 880.6265 and reviewed by the General Hospital panel.
What device class is FME?
Class I, regulation 21 CFR 880.6265. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FME?
Across 5 cleared submissions the average was 48 days from receipt to decision (median 56).
Which companies have the most FME clearances?
Kimberly-Clark Corp. (1); American Hospital Supply Corp. (1); General Medical Co. (1); Graham Manufacturing Co. (1); Precept, Inc. (1).
Have FME devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2009-12-23.
Next steps
- Run an FDA pathway report with predicate devices for product code FME
- Run a recall and safety report across every FME manufacturer
- Watch product code FME 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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