← Product Code FRO · K964701

# MITRAFLEX PIGMENTED WOUND DRESSING (K964701)

_Polymedica Industries, Inc. · FRO · Feb 7, 1997 · SU · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K964701

## Device Facts

- **Applicant:** Polymedica Industries, Inc.
- **Product Code:** FRO
- **Decision Date:** Feb 7, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Device Class:** Class U
- **Review Panel:** SU
- **Attributes:** Therapeutic

## Intended Use

MITRAFLEX Pigmented Wound Dressings are intended for use in the management of: Venous stasis ulcers Diabetic ulcers Pressure sores Donor sites Blisters Incisions Severe sunburn Poison Ivy Dermabrasions and other dermatologic procedures Facelifts and other plastic surgery procedures (e.g. laser resurfacing) Partial-thickness wounds Superficial burns Abrasions and lacerations Full-thickness wounds Skin tears Dermal lesions Minor chemical burns Thermal burns

## Device Story

Sterile, absorptive, adhesive, conformable wound dressing; three-layer construction. Wound contact surface: porous adhesive for application. Second layer: microporous polyurethane membrane; absorbs/acts as reservoir for exudate; moisture vapor permeable; maintains moist environment; impermeable to microorganisms/liquids. Used in clinical/home settings for wound management; applied by healthcare providers or patients. Benefits: promotes optimal wound repair; protects wound site.

## Clinical Evidence

Bench testing only. Laboratory tests demonstrated the device is nontoxic, nonirritating, and nonsensitizing.

## Technological Characteristics

Three-layer construction; microporous polyurethane membrane; porous adhesive contact surface. Moisture vapor permeable; impermeable to microorganisms and liquids. Sterile.

## Predicate Devices

- MITRAFLEX Wound Dressings
- MITRAFLEX Wound Dressings, Wet-Stick

## Submission Summary (Full Text)

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k964701
FEB - 7 1997

# 510(k) Summary

|  Proprietary Name: | MITRAFLEX® Pigmented Wound Dressing  |
| --- | --- |
|  Common Name: | Dressing  |
|  Classification: | Unclassified  |
|  Submitter’s Details: | PolyMedica Industries, Inc.
581 Conference Place
Golden, CO 80401
Tel: (303)271-0300
FAX: (303)271-0397
Contacts: Andrew M. Reed, Ph.D., Julie Chaffee  |

## Description:

MITRAFLEX Pigmented Wound Dressings are sterile, absorptive dressings.

MITRAFLEX combines the moist wound environment properties of film dressings with the absorptive qualities of traditional therapies in a structure which is both adhesive and conformable.

MITRAFLEX dressings are constructed of three layers, each specifically engineered to give MITRAFLEX its unique blend of “ease of use” features while providing a microenvironment conducive to moist wound healing.

The wound contact surface of MITRAFLEX is a porous adhesive which facilitates ease of application to the wound site. A second layer consisting of a microporous polyurethane membrane absorbs and acts as a reservoir for wound exudate. This layer is also moisture vapor permeable which facilitates the reduction of exudate while maintaining a moist environment to promote optimal wound repair. MITRAFLEX is impermeable to microorganisms and liquids.

MITRAFLEX Pigmented Wound Dressings are intended for use in the management of:

- Venous stasis ulcers
- Diabetic ulcers
- Pressure sores
- Donor sites
- Blisters
- Incisions
- Severe sunburn
- Poison Ivy
- Dermabrasions and other dermatologic procedures
- Facelifts and other plastic surgery procedures (e.g. laser resurfacing)
- Partial-thickness wounds
- Superficial burns
- Abrasions and lacerations
- Full-thickness wounds
- Skin tears
- Dermal lesions
- Minor chemical burns
- Thermal burns

MITRAFLEX Pigmented Wound Dressings are substantially equivalent to MITRAFLEX Wound Dressings, Wet-Stick, and MITRAFLEX Wound Dressings. These devices are all self-adhesive wound dressings which provide a degree of absorption and breathability. They are all intended for use in the management of a wide variety of dermal lesions and injuries.

MITRAFLEX Pigmented Wound Dressings have been shown in laboratory tests to be nontoxic, nonirritating, and nonsensitizing.

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**Source:** [https://fda.innolitics.com/device/K964701](https://fda.innolitics.com/device/K964701)

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