← Product Code EFQ · K970455

# DUKAL NON ADHERENT DRESSING (K970455)

_Dukal Corp. · EFQ · May 8, 1997 · SU · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K970455

## Device Facts

- **Applicant:** Dukal Corp.
- **Product Code:** EFQ
- **Decision Date:** May 8, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Device Class:** Class U
- **Review Panel:** SU
- **Attributes:** Therapeutic

## Intended Use

Absorbent non adherent dressing is used as a topical dressing to cover a wound or operative site while providing absorbency.

## Device Story

Dukal Non Adherent Pad; topical wound dressing; provides wound coverage and absorbency; used in clinical or home settings; applied by healthcare providers or patients; physical barrier function; prevents adherence to wound bed.

## Clinical Evidence

Bench testing only; physical property comparison provided.

## Technological Characteristics

Non-adherent pad; thickness 47 mil; Delnet fracture 5lb/in; T-Peel 700 lb/in; absorptive capacity 38 oz/yd²; MD tensile 6lb/in; basis weight 5.0 oz/yd².

## Predicate Devices

- Kendell Non Adherent Dressing

## Submission Summary (Full Text)

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4F-1997 15:26 RMS 813 942 3828 P.04
K970455

# 510(K) SUMMARY
(as required by 807.92(c))

MAY - 8 1997

Submitter of 510(k):
Regulatory & Marketing Services, Inc. (RMS)
40178 U.S. 19 North
Tarpon Springs, FL 34689
Phone: 813-942-3908
Fax: 813-942-3828

Contact Person: Ed Ransom

Date of Summary: February 3, 1997

Trade Name: Dukal Non Adherent Pad

Classification Name: Dressing

Predicate Device: Kendell Non Adherent Dressing

Device Description/
Comparison:

|  Material | Dukal | Kendall  |
| --- | --- | --- |
|  Thickness | 47 mil | same  |
|  Delnet Fracture | 5lb/in | same  |
|  T-Peel | 700 lb/in | same  |
|  Absorptive Capacity | 38 oz/yd² | same  |
|  MD Tensile | 6lb/in | same  |
|  Basis weight | 5.0 oz/yd² | same  |
|  Intended Use | Absorbent non adherent dressing is used as a topical dressing to cover a wound or operative site while providing absorbency. | same  |

Intended Use: Absorbent non adherent dressing is used as a topical dressing to cover a wound or operative site while providing absorbency.

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**Source:** [https://fda.innolitics.com/device/K970455](https://fda.innolitics.com/device/K970455)

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