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510(k) Data Aggregation
K Number
K214017Device Name
Examination gloves-Type A(Latex gloves)
Manufacturer
Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd
Date Cleared
2022-07-14
(204 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
**Jiangxi Kemei Medical Apparatus **& Instruments Group Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Examination gloves-Type A (Latex gloves) is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
The proposed device, The Examination gloves-Type A ( Latex gloves ) is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. The proposed device is made of natural rubber latex and meet all the current specifications listed under the ASTM Specification D3578-19, Standard Specification for Rubber Examination Gloves. The principal operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is provided non-sterile and the shelf life is 5 years.
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K Number
K211953Device Name
Disposable Sterilized Latex Surgical Gloves
Manufacturer
Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd
Date Cleared
2022-05-25
(336 days)
Product Code
KGO
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
**Jiangxi Kemei Medical Apparatus **& Instruments Group Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Disposable Sterilized Latex Surgical Glove is a device made of nature rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Device Description
The proposed device, Disposable Sterilized Latex Surgical Gloves is a sterilized and disposable medical glove intended to be worn by operating room personnel to protect a surgical wound from contamination. The proposed device is made of natural rubber latex, per standard ASTM D3577-09(15), the rubber surgical gloves classification is: "Type 1-gloves compounded primarily from nature rubber latex." The gloves are powder-free and available in white in sizes 6, 6.5, 7, 7.5, 8, and 8.5. The proposed device is provided EO sterilized to achieve the sterility Assurance Level (SAL) of 106. The disposable sterilized latex surgical glove shelf life is 3 years.
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K Number
K212290Device Name
Examination gloves -Type C (Nitrile gloves)
Manufacturer
Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd
Date Cleared
2021-10-28
(99 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
**Jiangxi Kemei Medical Apparatus **& Instruments Group Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Examination gloves-Type C (Nitrile gloves) is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
The proposed device is one kind of patient examination glove made from nitrile rubber compounds. The typical characters of these examination gloves are blue color, single-layer, powder-free, non-sterilized, single-use, variable size (see table 2.). These examination gloves can be worn on the examiner's hands or fingers during a medical examination. In addition, it is for over-the-counter use and also for adult use only.
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