Search Results
Found 4 results
510(k) Data Aggregation
K Number
K141619Device Name
LUOFUCON SILVER FOAM DRESSING
Manufacturer
HUIZHOU FORYOU MEDICAL DEVICES CO, LTD
Date Cleared
2015-04-06
(293 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
HUIZHOU FORYOU MEDICAL DEVICES CO, LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Luofucon Silver Foam Dressing is indicated for exudate absorption and the management of partial to full thickness wounds. Some typical wounds are:
- · Ulcers (venous, arterial, diabetic)
- Pressure Sores
- · Donor Sites
- · Surgical Incisions
- · Surgical Excisions
- · Burns (1st and 2nd degree)
Device Description
Luofucon Silver Foam Dressing is a sterile, single-use dressing composed of polyurethane and silver particles, which absorbs wound exudate and releases silver ions in the presence of wound fluid. It also assists in maintaining a moist environment for optimal wound healing, and allows intact removal.
The polyurethane material consists of metallic silver that provides effective protection of the dressing material (not wound) against bacterial contamination. The silver is a preservative that protects the dressing material (not wound) from a broad spectrum of bacteria over three days, based on in vitro laboratory testing.
All dressings are sterilized and sold directly to users after sterilization by EtO using conditions validated following ISO 11135-1: 2007.
The silver foam dressing in this submission consists of four variants:
The basic model, dressing without backing, is a sterile highly absorbing open cell hydrophilic wound dressing composed of a thick soft, smooth, elastic and breathable Polyurethane foam encapsulated with silver particles as an antimicrobial barrier. The product line is available in different sizes.
A second variant, non adhesive PU backing variant, has a two-layered structure: a thick layer of soft, smooth elastic and breathable Polyurethane foam encapsulated with silver particles, and a thin layer (0.025±0.005 mm thick) of non porous breathable Polyurethane film (backing film) laminated on the outer side (non-wound contacting side) of the thick layer. The thin backing has the same area as the thick soft Polyurethane layer and is for cosmetic purpose. The product line is available in different sizes.
A third adhesive variant, bordered PU adhesive backing variant, has a three-layered structure. A thin Polyurethane film layer (0.04±0.005 mm thick), served as backing, is laminated to the top of the thick layer of soft, breathable, and silver encapsulated Polyurethane foam. Then on top of second layer is a large thin film of Poly(ethylene terephthalate) (PET) (0.04±0.005 mm thick) with pressure-sensitive adhesive to secure the dressing on patient skin surface. The backing polyurethane layer and PET layer are waterproof and semi permeable, and are used to secure the foam onto patient skin. The product line is available in different sizes.
A fourth adhesive variant, bordered non-woven adhesive backing variant, is similar to the third variant and also has a three layered structure. A thin Polyurethane film layer (0.04±0.005 mm thick), served as backing, is laminated to the top of the thick layer of soft, breathable, and silver encapsulated Polyurethane foam. Then on top of second layer is a large thin film of non-woven material (0.28±0.02 mm thick) with pressure-sensitive adhesive to secure the dressing on patient skin surface. The non woven material is made from viscose rayon fiber and poly(ethylene terephthalate) fiber. The backing polyurethane layer and non woven layer are waterproof and semi permeable, and are used to secure the foam onto patient skin. The product line is available in different sizes.
The dressing has white appearance and is available in the form of pad and in different sizes packaged in pouches. All dressings have the exactly the same material, chemical, and physical properties and are different only in size and backing.
Ask a Question
K Number
K132796Device Name
SUNTOUCH EYE SPEAR
Manufacturer
HUIZHOU FORYOU MEDICAL DEVICES CO, LTD
Date Cleared
2013-10-30
(54 days)
Product Code
HOZ
Regulation Number
886.4790Why did this record match?
Applicant Name (Manufacturer) :
HUIZHOU FORYOU MEDICAL DEVICES CO, LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Eye Spears are designed to absorb fluids and remove debris from the operative field or instruments during ophthalmic surgery.
Device Description
SUNTOUCH® Eye Spears are sterilized, single-use devices designed to absorb fluids and remove debris from the operative field or instruments during ophthalmic surgery. The Eye Spears include seven models which share same material. The models are different in size and configuration of plastic handle.
They are provided sterilized with Sterility Assurance Level (SAL) of 10-6.
Ask a Question
K Number
K120181Device Name
LUFUCON SILVER ALGINATE DRESSING 50X50MM, LUFUCON SILVER ALGINATE DRESSING 100X100MM, LUFUCON SILVER DRESSING 200X100MM
Manufacturer
HUIZHOU FORYOU MEDICAL DEVICES CO, LTD
Date Cleared
2013-02-14
(391 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
HUIZHOU FORYOU MEDICAL DEVICES CO, LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Prescription: Luofucon Silver Alginate Dressing is indicated for the management of moderate to heavily exuding partial to full thickness wounds, including postoperative wounds, trauma wounds, leg ulcers, pressure ulcers, diabetic ulcers, graft and donor sites.
OTC: First aid to help in minor abrasions, minor cuts, lacerations, scrapes, minor scalds and burns.
Device Description
Luofucon Silver Alginate Dressing is a sterile, non-woven pad composed of a high G (guluronic acid) calcium alginate and metallic silver particles, which absorbs wound exudate. As wound exudate is absorbed, the alginate forms a gel, which assists in maintaining a moist environment for optimal wound healing, and allows intact removal. The alginate material consists of metallic silver that provides effective protection against microbial contamination of the dressing material. Odour reduction results from the bacteria reduction effect in the dressing. The dressing has an off-white appearance and is available in the form of pad and in three different sizes (50 mm x 50 mm, 100 mm x 10 mm, 200 mm x 100 mm), packaged in pouches. Additional sizes may also be manufactured per customer request. 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.
Ask a Question
K Number
K112800Device Name
SUNTOUCH TOPICAL HEMOSTATIC DRESSING
Manufacturer
HUIZHOU FORYOU MEDICAL DEVICES CO, LTD
Date Cleared
2012-05-23
(239 days)
Product Code
QSY, FRO, REG
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
HUIZHOU FORYOU MEDICAL DEVICES CO, LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Prescription: Suntouch Topical Hemostatic Dressing is indicated for the management of topical wounds and to temporary control of external surface bleeding.
Over the Counter: Suntouch Topical Hemostatic Dressing is indicated for temporary external topical bleeding of minor cuts, minor lacerations, and it is contraindicated for internal use.
Device Description
The Suntouch Topical Hemostatic Dressing is made from regenerated cotton cellulose, chemically treated to become water-soluble. When contacting blood and exudates, they expand into clear gel, thereby adhering and creating pressure to seal the wound. The gauzes are sold in the following forms: Sheet, rolls, and pack (four layers).
Ask a Question
Page 1 of 1