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Found 20 results
510(k) Data Aggregation
K Number
K242615Device Name
Intermittent pressure compression system (Compression Pump PT1005A; Leg Compression Cuffs; L-1001S, L-1001L, L-1001XL, L-1001XXL, L-1001XXXL)
Manufacturer
Xiamen Taotao Technology Co.,Ltd.
Date Cleared
2025-07-23
(323 days)
Product Code
IRP
Regulation Number
890.5650Why did this record match?
Applicant Name (Manufacturer) :
Xiamen Tao**tao **Technology Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K240916Device Name
Surgical Face Mask (Tie on/ Ear loops)
Manufacturer
Xiantao Daoqi Plastic Co., Ltd.
Date Cleared
2024-10-18
(198 days)
Product Code
FXX
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Xian**tao **Daoqi Plastic Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Surgical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. It is 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 face mask is single use, three-layer, flat-pleated style with ear loops/ties and nose piece. The mask is manufactured with three layers, the inner and outer layers, and the straps are made of nonwoven fabrics, the middle layer is made of melt blown fabrics.
The model of proposed device, tie-on, is held in place over the user's mouth and nose by four ties welded to the face mask. The tie is made of spun-bond polypropylene.
The model of proposed device, ear loops, is held in place over the user's mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are not made with natural rubber latex.
The ties/ear loops are not made with natural rubber latex. The nose piece on the layers of face mask is to allow the user to fit the face mask around their nose, which is made of Polypropylene with iron core. The Surgical face mask will be provided in blue. The masks are sold non-sterile and are intended to be single use, disposable devices.
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K Number
K231510Device Name
Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S,M,L,XL,XXL,XXXL)
Manufacturer
Xiantao Zhibo Non-Woven Products Co., Ltd.
Date Cleared
2023-08-22
(89 days)
Product Code
FYA
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Xian**tao **Zhibo Non-Woven Products Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Surgical Gowns are intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate matter. This is a single use, disposable device, provided sterile.
Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the Surgical Gown and Reinforced Surgical Gown met the requirements for Level 3 classification.
Device Description
The proposed device Surgical Gown its body, sleeve and belt are made of SMMS non-woven material, and cuff is made of cotton. The proposed device is available in S(110×130cm), M(120×140cm), L(130×150cm), XL(140×160cm), XXL(150×170cm), XXXL(155×180cm) sizes . This proposed device can meet the requirements for Level 3 per ANSI/AAMI PB70:2012.
The proposed device Reinforced Surgical Gown is its body, sleeve and belt are made of SMMS nonwoven material, and cuff is made of cotton. The reinforced and critical zone is front chest and sleeves. This zone is reinforced with PP/PE composite breathable film. The proposed device is available in S(110×130cm), M(120×140cm), L(130×150cm), XL(140×160cm), XXL(150×170cm), XXXL(155×180cm) sizes. This proposed device can meet the requirements for Level 3 per ANSI/AAMI PB70:2012.
The proposed devices are disposable medical devices and provided in sterile.
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K Number
K222651Device Name
Surgical Face Mask
Manufacturer
Xiantao Sanda Industrial Co., Ltd
Date Cleared
2022-12-13
(103 days)
Product Code
FXX
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Xian**tao **Sanda Industrial Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Surgical Face Mask is intended to be worn to protect both the patient and healthcare personnel 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. This a single use, disposable device(s), provided non-sterile.
Device Description
The Surgical Face Masks are blue color, there-layer, flat-pleaded masks with nose piece and ear loops/ties, which are composed of outer layer, middle layer and inner layer. The outer layer and inner layer of the mask are made of polypropylene, the middle layer is made of melt-blown polypropylene. The ear loop/ties of the subject mask is held in place over the users' mouth and nose by two ear loops/ties welded to the face mask. The ear loop is made with polyester and spandex. The nose piece in the layers of face mask is to allow the user to fit the mask around their nose, which is made of high density polyethylene. The Surgical Face Mask is sold non-sterile and are intended to be single use, disposable devices. The mask is designed and manufactured in accordance with ASTM F2100 Standard Specification for Performance of Materials Used in Surgical Face Masks.
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K Number
K223055Device Name
Disposable Medical Face Mask
Manufacturer
Xiantao Zhuobo Industrial Co., LTD
Date Cleared
2022-12-05
(67 days)
Product Code
FXX
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Xian**tao **Zhuobo Industrial Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Disposable Medical Face Mask is intended to be worn to protect 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
Disposable Medical Face Mask is a blue flat-pleated mask, which is worn in the way of earrings and has a nose clip design to fit the mask around the nose. This product is composed of a mask body (three-layer structure: two layers of polypropylene adhesive nonwoven fabric with a layer of polypropylene melt-blown nonwoven fabric in the middle), a nose clip (made of polyethylene) and ear loops (made of polyester + spandex). The nose clip is located in the middle layer of the mask. Ear loops, string-like material, are attached to the mask and placed behind the ears. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
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K Number
K222529Device Name
Surgical Face Mask
Manufacturer
Xiantao Rayxin Medical Products Co., Ltd.
Date Cleared
2022-11-14
(84 days)
Product Code
FXX
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Xian**tao **Rayxin Medical Products Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Surgical Face Mask is 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 Face Mask is single use, three-layer, flat-pleated style with ear loops/tie-coverall and nose piece. The Surgical Face Mask is manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The ties/ear loops are held in place over the users' mouth and nose by two ties/ear loops welded to the facemask. The loops are made of polyester and spandex, the ties are made of spun-bond polypropylene. The nose clamp in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of polypropylene and aluminum. The Surgical Face Mask will be provided in blue. The Surgical Face Mask is sold as non-sterile and are intended to be single use, disposable devices.
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K Number
K211060Device Name
Disposable Surgical Gown Rk-3011C
Manufacturer
Xiantao Rhycom Non-woven Products Co., Ltd
Date Cleared
2022-10-28
(567 days)
Product Code
FYA
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Xian**tao **Rhycom Non-woven Products Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Disposable Surgical Gown Rk-3011C is intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate material.
Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the Disposable Surgical Gown Rk-3011C surgical gowns met the requirements for Level 3 classification.
This is a single use, disposable device(s), provided non-sterile. The Surgical Gowns is to be sold to re-packager/re-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135 prior to marketing to the end user.
Device Description
The proposed surgical gown is a single use, disposable medical device provided as bulk, non-sterile items to repackagers/ relablers for further packaging and Ethylene Oxide (EO) sterilization.
The gown is manufactured with four layers: the inner and outer layers are made of spun-bond polypropylene and the middle layers are made of melt blown polypropylene. All gowns are reinforced with polypropylene and microporous reinforcement material. The proposed surgical gown is only available in the available sizes of the proposed surgical gown are M, L, XL, and XXL.
The cuffs are composed of cotton and terylene. The back is open with ties to secure the gown.
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K Number
K221977Device Name
Disposable Surgical Gown (G4003)
Manufacturer
Xiantao Topmed Nonwoven Protective Products Co., Ltd.
Date Cleared
2022-10-20
(107 days)
Product Code
FYA
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Xian**tao **Topmed Nonwoven Protective Products Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Disposable Surgical Gowns are intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate matter.
In addition, this surgical gown meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). This is a single use, disposable device, provided sterile. The surgical gown has six sizes - S, M, L, XL, XXL and XXXL.
Device Description
The Disposable surgical gown is composed of collar, body, sleeve and tie. The back is full opening, the neck and waist are laced, the sleeve are made of cotton closure by sewing, and the rest are made of heat sealing. It has been tested according to AAMI PB70:2012 and meet AAMI Level 3 barrier level protection for a surgical gown.
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K Number
K221976Device Name
Surgical Face Mask (Non-sterile)
Manufacturer
Xiantao Junhui Plastic Products Co., Ltd.
Date Cleared
2022-09-20
(77 days)
Product Code
FXX
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Xian**tao **Junhui Plastic Products Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Surgical Face Mask (Non-sterile) is intended to be worn to protect both the patient and healthcare personnel 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. This a single use, disposable device(s), provided non-sterile.
Device Description
The Surgical Face Masks (Non-sterile) are blue color, three-layer, flat-pleaded masks with nose piece and ear loops, which are composed of inner layer and outer layer. The colorant is blue polypropylene (PP) master batch.
The inner layer and outer layer of the mask are made of spun-bonded non-woven fabric (polypropylene), the middle layer is made of polypropylene melt-blown non-woven fabric. The ear loop of the subject mask is held in place over the users' mouth and nose by two ear loops welded to the face mask. The ear loop is made with nylon and spandex. The nose piece in the layers of face mask is to allow the user to fit the mask around their nose, which is made of galvanized iron wire coated by PE.
The Surgical Face Mask (Non-sterile) is sold non-sterile and are intended to be single use, disposable devices.
The mask is designed and manufactured in accordance with ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks.
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K Number
K221196Device Name
Disposable Medical Face Mask (ear loop)
Manufacturer
Xiantao Topmed Nonwoven Protective Products Co., Ltd.
Date Cleared
2022-07-22
(88 days)
Product Code
FXX
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Xian**tao **Topmed Nonwoven Protective Products Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Disposable Medical Face 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 Disposable Medical Face Mask is blue color, single use, flat-folded masks with nose piece and ear loops. The blue colorant is polypropylene (PP) master batch.
The body of the mask is composed of three layers: the inner and outer layers are made of polypropylene spun-bond nonwoven fabric, and the middle layer is made of polypropylene melt blown non-woven fabric. The nose clip is made of Galvanized iron wire coated by PE, and the ear loop is made of polyester and spandex.
The disposable medical face masks are sold non-sterile and are intended to be single use, disposable devices.
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