FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

K Number

K211516

Device Name

Disposable Vinyl Nitrile Synthetic Gloves Powder Free

Manufacturer

Tangshan Hongyun Plastic Products Co., Ltd.

Date Cleared

2021-08-24

(99 days)

Product Code

LYZ

Regulation Number

880.6250

Intended Use

A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands to prevent contamination between patient and examiner.

Device Description

The subject device is powder free vinyl synthetic patient examination gloves. The subject device is blue. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is non-sterile.

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K Number

K141878

Device Name

HONGYUN POWDER-FREE YELLOW VINYL PATIENT EXAMINATION GLOVES

Manufacturer

TANGSHAN HONGYUN PLASTIC PRODUCTS CO., LTD.

Date Cleared

2014-12-24

(166 days)

Product Code

LYZ

Regulation Number

880.6250

Intended Use

Powder-Free Yellow Vinyl Patient Examination Gloves is a non sterile 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

Powder-Free Yellow Vinyl Patient Examination Gloves that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011).

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K Number

K142343

Device Name

Hongyun Powder-Free Vinyl Patient Examination Gloves, Clear( Non-colored)

Manufacturer

TANGSHAN HONGYUN PLASTIC PRODUCTS CO., LTD

Date Cleared

2014-12-10

(111 days)

Product Code

LYZ

Regulation Number

880.6250

Intended Use

Powder-Free Vinyl Patient Examination Gloves, Clear (Non-colored) is a non-sterile 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

Powder-Free Vinyl Patient Examination Gloves, Clear (Non-colored) that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011). PVC films form a barrier to body fluids and bloodborne Pathogens. The PVC rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. PVC gloves are known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151 requirements.

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K Number

K071999

Device Name

POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)

Manufacturer

TANGSHAN HONGYUN PLASTIC PRODUCTS CO., LTD

Date Cleared

2008-05-08

(290 days)

Product Code

LYZ

Regulation Number

880.6250

Intended Use

Powdered vinyl 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.

Device Description

powdered vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-0084.

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K Number

K072001

Device Name

POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)

Manufacturer

TANGSHAN HONGYUN PLASTIC PRODUCTS CO., LTD

Date Cleared

2007-08-15

(23 days)

Product Code

LYZ

Regulation Number

880.6250

Intended Use

Powder free vinyl 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.

Device Description

powder free vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-00ed.

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