LYOFOAM EXTRA 'A' STERILE ADHESIVE WOUND DRESSING

K961452 · Acme United Corp. · KMF · May 31, 1996 · General Hospital

Device Facts

• Record ID: K961452
• Device Name: LYOFOAM EXTRA 'A' STERILE ADHESIVE WOUND DRESSING
• Applicant: Acme United Corp.
• Product Code: KMF · General Hospital
• Decision Date: May 31, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5090
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Lyofoam® Extra "A" Sterile Adhesive Wound Dressing is intended for the treatment of moderately to heavily exuding wounds while the Modified Lyofoam® Wound Dressing would be used to treat lightly to moderately exuding, wounds. Lyofoam® Extra "A" provides a waterproof barrier for the wound which is moisture vapor permeable and helps to prevent bacterial contamination of the wound.

Device Story

Lyofoam® Extra "A" is a sterile, adhesive, polyurethane foam island dressing; combines extra-absorbent foam pad with adhesive border. Device functions as a waterproof, moisture vapor permeable barrier to prevent bacterial contamination; absorbs excess wound fluid. Used in clinical or home settings for wound management. Healthcare providers apply dressing over wound; adhesive border secures device in place. Benefits include enhanced fluid management for heavily exuding wounds and protection against external contaminants.

Clinical Evidence

No clinical data. Performance and safety data rely on previously submitted files K952565 and K895764.

Technological Characteristics

Polyurethane foam island dressing; adhesive border; waterproof and moisture vapor permeable; sterilized via gamma radiation (SAL 10⁻⁶); packaged in paper/foil peel pouch.

Indications for Use

Indicated for patients with moderately to heavily exuding wounds requiring a sterile, waterproof, moisture vapor permeable, and bacterial-resistant dressing.

Regulatory Classification

Identification

A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.

Predicate Devices

• Modified Lyofoam® Wound Dressing (K895764)
• Lyofoam® Extra Absorbent Wound Dressing (K952565)

Submission Summary (Full Text)

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K961452
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Acme United Corporation

MAY 31 1996

510(K) SUMMARY

Submitter's Name: Acme United Corporation
75 Kings Highway Cutoff
Fairfield, CT 06430

Contact Person: Thomas E. Flynn, Director of Regulatory
Affairs and Quality Assurance

Telephone Number: 203-332-7330
Fax Number: 203-576-0007
Date of Submission:

"This summary of 510(K) safety and effectiveness information
is being submitted in accordance with the requirements of SMDA
1990 and 21 CFR 807.92."

The assigned 510(K) number is:

Proprietary Name of Device: Lyofoam® Extra "A" Sterile Adhesive
Wound Dressing
Common/Usual Name: Extra absorbent, polyurethane foam
island dressing.
Classification Name: Dressing, Class I
Product Claiming
Equivalence To: Modified Lyofoam® Wound Dressing and
Lyofoam® Extra Absorbent Wound
Dressing
Description of Device: Lyofoam® Extra "A", Extra Absorbent,
Non-Adherent Polyurethane Foam
Dressing with adhesive boarder.

)

Medical Products Division • 75 Kings Highway Cutoff, Fairfield, Connecticut 06430 • Phone [phone]

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# Acme United Corporation

Intended Use, Comparison To Predicate Device:

The Lyofoam® Extra "A" Sterile Adhesive Wound Dressing is a combination of the Lyofoam® Extra product and the Modified Lyofoam® Dressing Product (Lyofoam® "A"). The main difference between them is that Lyofoam® Extra Foam Dressing is used in place of the regular Lyofoam® for the wound dressing pad segment of this product. The third layer of thin foam is extended beyond the wound pad and has a adhesive coating which is used to hold the product in place over the wound.

The inner absorbent layer of Lyofoam® Extra Wound Dressing Pad holds more excess wound fluid than the Modified Lyofoam® Wound Dressing Pad which is made from regular Lyofoam®. The Lyofoam® Extra "A" Sterile Adhesive Wound Dressing is intended for the treatment of moderately to heavily exuding wounds while the Modified Lyofoam® Wound Dressing would be used to treat lightly to moderately exuding, wounds. Lyofoam® Extra "A" provides a waterproof barrier for the wound which is moisture vapor permeable and helps to prevent bacterial contamination of the wound.

Medical Products Division • 75 Kings Highway Cutoff, Fairfield, Connecticut 06430 • Phone [phone]

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Acme United Corporation

Performance data for this product can be found in the Lyofoam® Extra 510(K) File K952565.

Safety:
Safety test data can be found in both the Lyofoam® Extra 510(K) file K952565 and Modified Lyofoam® Dressing file; K895764. All safety data is summarized in those files and indicates product is safe for use.

Sterility and Packaging:
Lyofoam® Extra "A" Sterile Adhesive Wound Dressing is packaged in a paper/foil peel pouch and is sterilized using gamma radiation and has a SAL 10⁻⁶.

Medical Products Division • 75 Kings Highway Cutoff, Fairfield, Connecticut 06430 • Phone [phone]