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510(k) Data Aggregation
K Number
K231088Device Name
Copper Foam Dressing (Prescription and OTC)
Manufacturer
Roosin Medical Co., Ltd.
Date Cleared
2024-01-11
(269 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Roosin Medical Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Prescription use indications (Rx-only):
- · Partial and full thickness wounds,
- · Pressure ulcers (stage I-IV),
- · Diabetic ulcers,
- · Venous stasis ulcers,
- · Arterial ulcers.
- · 1st and partial thickness burns,
- · Surgical wounds,
- · Vascular access or peripheral IV sites,
- · Orthopedic external pin sites, and
- · Acute wounds such as lacerations, abrasions, and skin tears.
Over-The-Counter (OTC) use indications:
Local management of superficial wounds, minor burns, abrasions and lacerations (tears).
Device Description
"Copper Foam Dressing (Prescription and OTC)" is a sterile, single-use dressing composed of polyurethane and copper oxide particles, which absorbs wound exudate and releases copper ions in the presence of wound fluid. It also assists in maintaining a moist environment for optimal wound healing, and allows intact removal.
Based on in vitro laboratory testing, the copper has been shown to inhibit bacterial growth within the dressing for up to 7 days.
The dressing has an off-white appearance and is available in the form of pad and in various different sizes packaged in pouches. All dressings have the exactly the same material, chemical, and physical properties and are different only in size.
All dressings are sterilized and sold directly to users after sterilization by radiation using conditions validated following ISO 11137-2: 2006.
Stability study shows the product has a shelf life of three years.
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K Number
K230190Device Name
Polyver Silver Alginate Dressing (Prescription and OTC)
Manufacturer
Roosin Medical Co., Ltd.
Date Cleared
2023-11-17
(297 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Roosin Medical Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Prescription Use:
"Polyver Silver Alginate Dressing" is indicated for the management of moderate to heavily exuding partial to full thickness wounds, including, postoperative wounds, leg ulcers, pressure ulcers, diabetic ulcers, graft and donor sites.
OTC Use:
First aid to help in minor abrasions, minor lacerations, minor scrapes, minor scalds and minor burns
Device Description
"Polyver Silver Alginate Dressing (Prescription and OTC)" is a sterile, non-woven pad composed of a high G (guluronic acid) calcium alginate and silver particles, which releases silver ions within the dressing and absorbs wound exudate. As wound exudate is absorbed, the alginate forms a gel, which assists in maintaining a moist environment.
The dressing may be used for periods up to 7 days, and can be removed intact during dressing changes
The alginate material consists of silver that controls bacterial growth within the dressing. Based on in vitro laboratory testing, the silver has been shown to protect the dressing against Gram positive and Gram negative bacteria, such as Escherichia coli, Klebsiella pneumonia, Pseudomonas aeruginosa, Staphylococcus aureus, Staphylococcus epidermidis, Enterococcus faecalis.
Based on in vitro testing, the silver effectively reduces bacterial growth within the dressing for up to seven days. Use of this device should be discontinued completely after 7 days.
No clinical benefit has been demonstrated regarding the effectiveness of silver in the subject dressing.
The dressing has an off-white appearance and is available in the form of pad and in various different sizes packaged in pouches. All dressings have the exactly the same material, chemical, and physical properties and are different only in size.
All dressings are sterilized and sold directly to users after sterilization by radiation using conditions validated following ISO 11137-2: 2006.
Stability study shows the product has a shelf life of three years.
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K Number
K181478Device Name
Roosin Xeroform Petrolatum Dressing
Manufacturer
Roosin Medical Co., Ltd
Date Cleared
2019-09-13
(465 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Roosin Medical Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Roosin Xeroform Petrolatum Dressing is intended for use as a primary contact layer in dressing wounds such as lacerations, skin graft recipient sites, newly sutured wounds, abrasions, and minor or partial thickness burns. It may also be used as an initial layer in dressing surgical wounds with light exudate.
Device Description
Roosin Xeroform Petrolatum Dressing is a type of wound dressing and has ingredients of finely woven mesh gauze infused with a blend of petrolatum and 3% Bismuth Tribromophenate. It is a sterile, single use dressing. This is a combination product. Roosin Xeroform Petrolatum Dressing is used as a primary contact layer in dressing for wounds such as lacerations, skin graft recipient sites, newly sutured wounds, abrasions, and minor or partial thickness burns. The dressing has a yellow appearance and is available in the form of pad and in four different sizes (2" x 2", 1" x 8", 4" x 4", 5" x 9"), packaged in pouches. All dressings are sterilized by gamma radiation using conditions validated following ISO 11137-2: 2013.
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