← Product Code [FME](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FME) · K880385

# KIMBERLY-CLARK PROFESSIONAL JACKET (K880385)

_Kimberly-Clark Corp. · FME · Feb 19, 1988 · General Hospital · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FME/K880385

## Device Facts

- **Applicant:** Kimberly-Clark Corp.
- **Product Code:** [FME](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FME.md)
- **Decision Date:** Feb 19, 1988
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.6265
- **Device Class:** Class 1
- **Review Panel:** General Hospital

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FME/K880385](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FME/K880385)

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