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510(k) Data Aggregation
K Number
K221570Device Name
Antibacterial bandage
Manufacturer
Date Cleared
2023-09-29
(486 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Allmed Medical Products Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Antibacterial bandages are to be applied to the skin for the management of minor cuts.minor scrapes. This device is only applicable to adults.
Device Description
The device, Antibacterial bandage, is to be applied topically to the skin for management of minor cuts, minor scrapes. Antibacterial bandage is made of polyethylene tape, absorbent pad and release paper. The absorbent pad contains 95±10 ug/cm2 (0.8% by weight) benzalkonium chloride. Antibacterial bandage is available in different sizes. The antibacterial bandage is EO sterilized and is for single use only.
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K Number
K202128Device Name
Allmed Surgical Face Masks (Ear loops)
Manufacturer
Date Cleared
2021-06-03
(307 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Allmed Medical Products Co., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Allmed Surgical Face Masks(Ear Loops) are intended to be worn to protect both patients and healthcare workers from transfer of microorganisms, body fluids, and particulate material. The surgical face mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. The surgical face mask is a single use, disposable device provided non-sterile.
Device Description
Allmed surgical face masks (ear loops) are composed of 3-layers and is flat-pleated. The mask materials consist of an outer layer (polypropylene spunbond, blue), filter layer (polypropylene meltblown, white), and inner layer (polypropylene spunbond, white). The three layers of the mask body are collated and sonically welded around the edges. The surgical face mask contains ear loops attached by welding to secure the mask over the user's mouth and face and includes a malleable nosepiece to provide a firm fit over the nose. The surgical face mask is a single use, disposable device, provided non-sterile.
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K Number
K202411Device Name
Surgical Mask
Manufacturer
Date Cleared
2021-03-10
(201 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Allmed Medical Products Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure of the wearer to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
Device Description
The Surgical Masks are blue color, single use, three-layer, flat -folded masks with nose clip and ear loops. The Surgical Masks are manufactured with three layers, the inner and outer layers are made of polypropylene spunbonded nonwoven, and the middle layer is made of polypropylene melt-blown nonwoven filter. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose clip in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of iron strip wrapped by plastic. The surgical masks are sold non-sterile and are intended to be single use, disposable devices.
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K Number
K202409Device Name
Surgical Mask
Manufacturer
Date Cleared
2021-03-09
(200 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Allmed Medical Products Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
Device Description
The Surgical Masks are blue color, single use, three-layer, flat -folded masks with nose clip and ear loops. The Surgical Masks are manufactured with three layers, the inner and outer layers are made of polypropylene spunbonded nonwoven, and the middle layer is made of polypropylene melt-blown nonwoven filter. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose clip in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of iron strip wrapped by plastic. The surgical masks are sold non-sterile and are intended to be single use, disposable devices.
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