Nitrile Gloves for examination are mainly used to protect the wearer and/or the patient from the spread of infection or illness during medical procedures and examinations and are also an example of personal protective equipment. Medical gloves are part of an infection-control plan. Medical gloves are disposable which include examination gloves, surgical gloves, and also medical gloves for handling chemotherapy agents (chemotherapy gloves).
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| Product code | ||
| LYY
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Device Name | Latex Patient Examination Glove |
| Class | 1 | |
| Regulation Name |
Non-powdered patient examination glove
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Regulation No.
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880.6250 |
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| Identification |
A non-powdered patient examination glove is a disposable device intended for medical purposes that are worn on the examiner’s hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.
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| Status | 510k | |
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Remarks
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A latex patient examination glove is a disposable device made of natural rubber latex that may or may not bear a trace amount of residual powder and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
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| LYZ | Device Name |
Vinyl Patient Examination Glove
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| Class |
1
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| Regulation Name |
Non-powdered patient examination glove
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Regulation No.
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| Identification |
A non-powdered patient examination glove is a disposable device intended for medical purposes that are worn on the examiner’s hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.
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| Status |
510k
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Remarks
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A vinyl patient examination glove is a disposable device made of poly(vinyl chloride) that may or may not bear a trace amount of residual powder and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
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| FMC |
Device Name
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Patient Examination Glove |
| Class |
1
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|
| Regulation Name |
Non-powdered patient examination glove
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|
Regulation No.
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|
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|
Identification
|
A non-powdered patient examination glove 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. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.
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Status
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510(k)
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Remarks
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NIL | |
| OPJ |
Device Name
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Medical Gloves With Chemotherapy Labelling Claims – Test For Use With Chemotherapy Drugs |
| Class |
1
|
|
| Regulation Name |
Non-powdered patient examination glove.
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Regulation No.
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|
|
| Identification |
A non-powdered patient examination glove 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. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.
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Status
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510(k)
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Remarks
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A disposable medical glove (examination or surgeons) that is worn on the examiner’s hand to prevent contamination between patient and examiner. In addition, these gloves have been tested for permeation and breakthrough resistance against various concentrations and types of chemotherapy drugs using test such as ASTM D6978-05, Standard Practice for Assessment of Resistance of medical Gloves to Permeation by Chemotherapy Drugs
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| OPI |
Device Name
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Antimicrobial Medical Glove |
| Class | 1 | |
| Regulation Name | Non-powdered patient examination glove. | |
| Regulation No.
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|
|
| Identification |
A non-powdered patient examination glove 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. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.
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| Status |
510(k)
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Remarks
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A disposable medical glove (examination or surgeons) that is worn on the examiner’s hand to prevent contamination between patient and examiner and to serve the indicated use of the added antimicrobial agent which may vary with the added antimicrobial agent.
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| LZC |
Device Name
|
Patient Examination Glove, Specialty |
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Class
|
1 | |
|
Regulation Name
|
Non-powdered patient examination glove. | |
|
Regulation No.
|
|
|
| Identification |
A non-powdered patient examination glove 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. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.
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|
Status
|
510(k)
|
|
|
Remarks
|
A disposable medical glove (examination or surgeons) that is worn on the examiner’s hand to prevent contamination between patient and examiner. In addition, these gloves have been tested for permeation and breakthrough resistance against various concentrations and types of chemotherapy drugs using test such as ASTM D6978-05, Standard Practice for Assessment of Resistance of medical Gloves to Permeation by Chemotherapy Drugs.
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| LZA |
Device Name
|
Polymer Patient Examination Glove |
| Class |
1
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|
|
Regulation Name
|
Non-powdered patient examination glove | |
|
Regulation No.
|
880.6250 | |
| Identification |
A non-powdered patient examination glove 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. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.
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Status
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510(k)
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Remarks
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A nitrile (or polymer) patient examination glove is a disposable device made of nitrile rubber or synthetic polymers that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
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| OIG |
Device Name
|
Powder-Free Guayle Rubber Examination Glove |
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Class
|
1
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|
|
Regulation Name
|
Non-powdered patient examination glove | |
|
Regulation No.
|
880.6250 | |
| Identification |
A non-powdered patient examination glove 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. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.
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Status
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510(k)
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Remarks
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A disposable patient examination glove made from guayule natural rubber latex. This alternative source of natural rubber latex (guayale) does not contain the same protein associated with allergic reactions to latex products from the hevea rubber tree. This device is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
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| OPC |
Device Name
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Powder-Free Polychloroprene Patient Examination Glove |
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Class
|
1 |
|
|
Regulation Name
|
Non-powdered patient examination glove | |
|
Regulation No.
|
880.6250 | |
| Identification |
A non-powdered patient examination glove 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. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.
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Status
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510(k)
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Remarks
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A powder free polychloroprene patient examination glove is a disposable device made of polychloroprene rubber that bears powder to facilitate donning, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
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| OPH |
Device Name
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Radiation Attenuating Medical Glove |
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Class
|
1 |
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Regulation Name
|
Non-powdered patient examination glove
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|
|
Regulation No.
|
880.6250 | |
| Identification |
A non-powdered patient examination glove 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. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.
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Status
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510(k)
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Remarks
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Radiations attenuating medical gloves are medical gloves that are used during medical or surgical procedures involving radiation to shield the hands of the wearer from scattered radiation exposure. The gloves offer some degree of protection to the hand from radiation exposure as well as protection from transmission of infectious agents. The use of these gloves includes procedures that require the use of fluoroscopy or radiography. In addition to meeting the requirements for examination or surgeons gloves, manufacturers should have technical data to show that their attenuation claims meet the energy range of x-rays normally used in medical procedures.
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| OPA |
Device Name |
Powder-Free Non-Natural Rubber Latex Surgeon’s Gloves
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Class
|
1 | |
|
Regulation Name
|
Non-powdered surgeon’s glove. | |
|
Regulation No.
|
878.4460 | |
| Identification |
A non-powdered surgeon’s glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon’s glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.
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| Status | 510(k) | |
| Remarks |
A powder-free surgeon’s glove is a disposable device made of non-natural rubber that may bear a trace amount of residual powder and it is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
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| KGO | Device Name |
Surgeon’s Gloves
|
|
Class |
1
|
|
|
Regulation Name
|
Non-powdered surgeon’s glove. | |
|
Regulation No.
|
878.4460 | |
| Identification |
A non-powdered surgeon’s glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon’s glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.
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|
| Status | 510(k) | |
| Remarks |
A surgeon’s glove is a disposable device made of natural rubber latex that may or may not bear powder to facilitate donning, and it is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
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