US FDA 510k and Registration for Gloves

Medical gloves are mainly used to protect the wearer and/or the patient from the spread of infection or illness during medical procedures and examinations and also an example of the personal protective equipment. Medical gloves are the 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).

 

 
Product code 
LYY

 

Device Name Latex Patient Examination Glove
Class1
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.

 

Status510(k)
 

Remarks

 

 

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.

 

 
LYZDevice Name 

Vinyl Patient Examination Glove

 

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.

 

 

Status 

510(k)

 

 

Remarks

 

 

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.

 

 
FMC 

Device Name

 

Patient Examination Glove
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.

 

 

Status

 

 

510(k)

 

 

Remarks

 

NIL
 
OPJ 

Device Name

 

Medical Gloves With Chemotherapy Labelling Claims – Test For Use With Chemotherapy Drugs
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.

 

 

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

 

OPI 

Device Name

 

Antimicrobial Medical Glove
Class1
Regulation NameNon-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.

 

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 and to serve the indicated use of the added antimicrobial agent which may vary with the added antimicrobial agent.

 

 
LZC 

Device Name

 

Patient Examination Glove, Specialty
 

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.

 

 

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.

 

 
LZA 

Device Name

 

Polymer Patient Examination Glove
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.

 

 

Status

 

 

510(k)

 

 

Remarks

 

 

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.

 

 
OIG 

Device Name

 

Powder-Free Guayle Rubber Examination Glove
 

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.

 

 

Status

 

 

510(k)

 

 

Remarks

 

 

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.

 

 
OPC 

Device Name

 

 

Powder-Free Polychloroprene Patient Examination Glove

 

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.

 

 

Status

 

 

510(k)

 

 

Remarks

 

 

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.

 

 

 
OPH 

Device Name

 

 

Radiation Attenuating Medical Glove

 

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.

 

 

Status

 

 

510(k)

 

 

Remarks

 

 

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.

 

 
OPA 

Device Name

 

 

Powder-Free Non-Natural Rubber Latex 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.

 

Status510(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.

 

 

 
KGODevice 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.

 

Status510(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.