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

K Number

K011613

Device Name

POWDER-FREE GREEN BARRIER-PRO SYNTHETIC BUTADIENE COPOLYMER EXAMINATION GLOVE

Manufacturer

SHIELD GLOVES MANUFACTURER (M) SDN BHD

Date Cleared

2001-09-17

(115 days)

Product Code

LZA

Regulation Number

880.6250

Intended Use

This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

Device Description

Class I latex patient examination glove 80LZA, powder free and meeting all the requirements of ASTM-D3578-61) Standard Specification for Latex Examination Gloves for Medical Application, except for the elongation at break parameter.

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K Number

K000156

Device Name

SMART SHIELD NON-STERILE POWDER-FREE PEPPERMINT SCENTED GREEN LATEX EXAMINATION GLOVES

Manufacturer

SHIELD GLOVES MANUFACTURER (M) SDN BHD

Date Cleared

2000-02-18

(30 days)

Product Code

LYY

Regulation Number

880.6250

Intended Use

Device Description

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K Number

K000217

Device Name

ROYAL SHIELD NON-STERILE PURPLE (PINK/BLUE) COLORED POWDERED LATEX EXAM WITH PROTEIN LABELING CLAIM [<200 MCG OR LESS] W

Manufacturer

SHIELD GLOVES MANUFACTURER (M) SDN BHD

Date Cleared

2000-02-18

(25 days)

Product Code

LYY

Regulation Number

880.6250

Intended Use

Device Description

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K Number

K992417

Device Name

ROYAL SHIELD NON-STERILE POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABELING CLAIM) 200 MCGM OR LESS OF TOTAL WATER EXTR

Manufacturer

SHIELD GLOVES MANUFACTURER (M) SDN BHD

Date Cleared

1999-09-13

(55 days)

Product Code

LYY

Regulation Number

880.6250

Intended Use

This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

Device Description

Class I latex patient examination gloves 80LYY, powdered and meeting all the requirements of ASTM-D3578-99 Standard Specification for Latex Examination Gloves for Medical Application.

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K Number

K992418

Device Name

ROYAL SHIELD NON-STERILE PINK COLORED POWDERED LATEX EXAMINATION GLOVE WITH AND WITHOUT STRAWBERRY SCENT AND WITH PROTEI

Manufacturer

SHIELD GLOVES MANUFACTURER (M) SDN BHD

Date Cleared

1999-09-13

(55 days)

Product Code

LYY

Regulation Number

880.6250

Intended Use

A medical glove to be worn on the hand of the health care and similar personnel to prevent contamination between health care personnel and patient.

Device Description

Class I latex patient examination gloves 80L Y Y, powdered and meeting all the requirements of ASTM-D3578-99 Standard Specification for Latex Examination Gloves for Medical Application.

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K Number

K992419

Device Name

ROYAL SHIELD NON-STERILE BLUE COLORED POWDERED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (200 MCGM OR

Manufacturer

SHIELD GLOVES MANUFACTURER (M) SDN BHD

Date Cleared

1999-09-13

(55 days)

Product Code

LYY

Regulation Number

880.6250

Intended Use

This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

Device Description

Class I latex patient examination gloves 80LYY, powdered and meeting all the requirements of ASTM-D3578-99 Standard Specification for Latex Examination Gloves for Medical Application.

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K Number

K991743

Device Name

ROYAL SHIELD NON-STERILE BUBBLE GUM SCENTED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (5O

Manufacturer

SHIELD GLOVES MANUFACTURER (M) SDN BHD

Date Cleared

1999-06-23

(33 days)

Product Code

LYY

Regulation Number

880.6250

Intended Use

This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

Device Description

Class I latex patient examination gloves 80LYY, powder free and meeting all the requirements of ASTM-D3578-95 Standard Specification for Latex Examination Gloves for Medical Application.

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K Number

K991744

Device Name

SMART SHIELD NON-STERILE POWDER-FREE, BLUE NITRILE EXAMINATION GLOVES WITH BUBBLEGUM SCENT

Manufacturer

SHIELD GLOVES MANUFACTURER (M) SDN BHD

Date Cleared

1999-06-23

(33 days)

Product Code

LZA

Regulation Number

880.6250

Intended Use

This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

Device Description

Class I Nitrile patient examination gloves 80LZA, powder free and meeting all the requirements of the ASTM Draft Standard Specification for Nitrile Examination Gloves for Medical Application.

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K Number

K991745

Device Name

ROYAL SHIELD NON-STERILE POWDER-FREE, GREEN LATEX EXAMINATION GLOVES WITH A PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM

Manufacturer

SHIELD GLOVES MANUFACTURER (M) SDN BHD

Date Cleared

1999-06-23

(33 days)

Product Code

LYY

Regulation Number

880.6250

Intended Use

A medical glove to be worn on the hand of the health care and similar personnel to prevent contamination between health care personnel and patient.

Device Description

Class I latex patient examination gloves 80LYY, powder free and meeting all the requirements of ASTM-D3578-95 Standard Specification for Latex Examination Gloves for Medical Application.

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K Number

K991746

Device Name

ROYAL SHIELD POWDER-FREE PINEAPPLE SCENTED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR

Manufacturer

SHIELD GLOVES MANUFACTURER (M) SDN BHD

Date Cleared

1999-06-23

(33 days)

Product Code

LYY

Regulation Number

880.6250

Intended Use

This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

Device Description

Class I latex patient examination gloves 80LYY, powder free and meeting all the requirements of ASTM-D3578-95 Standard Specification for Latex Examination Gloves for Medical Application.

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