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

K Number

K982600

Device Name

PROFEEL SYNTHETIC COPOLYMER SURGICAL GLOVES (POWDERED)

Manufacturer

WEMBLEY RUBBER PRODUCTS (M) SDN BHD

Date Cleared

1999-03-12

(228 days)

Product Code

KGO

Regulation Number

878.4460

Intended Use

The surgeon's glove is a device made of synthetic copolymer intended to be worn by surgeons and/or operating room personnel to protect a surgical wound from contamination.

Device Description

Class I synthetic surgeon's glove, 79 KGO, powdered. It is a styrene-butadiene block copolymer glove.

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K Number

K972616

Device Name

ONCOLOGY PLUS POWDER FREE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING)

Manufacturer

WEMBLEY RUBBER PRODUCTS (M) SDN BHD

Date Cleared

1999-01-27

(562 days)

Product Code

LYY

Regulation Number

880.6250

Intended Use

1. The chemotherapy examination glove is a specialty medical glove which is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between examiner and chemotherapy agents.

Device Description

Class I latex patient examination glove 80 LZC, powder free, protein content labeling, that meets all of the requirements of ASTM standard D3578-91.

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K Number

K972615

Device Name

CHEMO PLUS POWDER FREE BLUE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING)

Manufacturer

WEMBLEY RUBBER PRODUCTS (M) SDN BHD

Date Cleared

1999-01-26

(561 days)

Product Code

LYY

Regulation Number

880.6250

Intended Use

1. The chemotherapy examination glove is a specialty medical glove which is a The onemedial device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between examiner and chemotherapy agents.

Device Description

Class I latex patient examination glove 80 LZC, powder free, protein content labeling, that meets all of the requirements of ASTM standard D3578-91.

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K Number

K972621

Device Name

PROFEEL POWDER FREE SURGICAL GLOVES (PROTEIN CONTENT LABELING)

Manufacturer

WEMBLEY RUBBER PRODUCTS (M) SDN BHD

Date Cleared

1997-10-24

(102 days)

Product Code

KGO

Regulation Number

878.4460

Intended Use

The surgeon's glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

Device Description

Class I natural rubber latex surgeon glove, 79 KGO, powder free, protein content labeling, that meets all of the requirements of ASTM standard D3577-91.

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K Number

K953213

Device Name

COMFIT (POWDER FREE EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN, BEADED)

Manufacturer

WEMBLEY RUBBER PRODUCTS (M) SDN BHD

Date Cleared

1996-10-11

(459 days)

Product Code

LYY

Regulation Number

880.6250

Intended Use

The gloves are intended to be worn on the hand of healthcare personnel, operating room personnel and similar personnel to prevent contamination between the healthcare or similar personnel and the patient's body, fluids, waste, or environment.

Device Description

Class I latex patient examination glove 80 LYY, powder free, hypoallergenic, protein labeling content, that meets all of the requirements of ASTM standard D3578-91.

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K Number

K962188

Device Name

COMFIT POWDER FREE BLUE EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN)

Manufacturer

WEMBLEY RUBBER PRODUCTS (M) SDN BHD

Date Cleared

1996-07-26

(50 days)

Product Code

LYY

Regulation Number

880.6250

Intended Use

The gloves are intended to be worn on the hand of healthcare personnel, operating room personnel and similar personnel to prevent contamination between the healthcare or similar personnel and the patient's body, fluids, waste, or environment.

Device Description

Class I latex patient examination glove 80 LYY, powder free, hypoallergenic, low protein, that meets all of the requirements of ASTM standard D3578-91.

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K Number

K962189

Device Name

COMFIT POWDER FREE GREEN EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN)

Manufacturer

WEMBLEY RUBBER PRODUCTS (M) SDN BHD

Date Cleared

1996-07-26

(50 days)

Product Code

LYY

Regulation Number

880.6250

Intended Use

The gloves are intended to be worn on the hand of healthcare personnel, operating room personnel and similar personnel to prevent contamination between the healthcare or similar personnel and the patient's body, fluids, waste, or environment.

Device Description

Class I latex patient examination glove 80 LYY, powder free, hypoallergenic, low protein, that meets all of the requirements of ASTM standard D3578-91.

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K Number

K953590

Device Name

COMFIT

Manufacturer

WEMBLEY RUBBER PRODUCTS (M) SDN BHD

Date Cleared

1996-06-27

(332 days)

Product Code

LYY

Regulation Number

880.6250

Intended Use

The gloves are intended to be worn on the hand of healthcare personnel, operating room personnel and similar personnel to prevent contamination between the healthcare or similar personnel to provent containmation between environment environment.

Device Description

Class I latex patient examination glove 80 LYY, powder free, hypoallergenic, protein labeling content, that meets all of the requirements of ASTM standard D3578-91.

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K Number

K960178

Device Name

COMFIT BROWN, BEADED SURGEON'S GLOVES (POWDERED, HYPOALLERGENIC)

Manufacturer

WEMBLEY RUBBER PRODUCTS (M) SDN BHD

Date Cleared

1996-05-06

(111 days)

Product Code

KGO

Regulation Number

878.4460

Intended Use

The gloves are intended to be worn on the hand of healthcare personnel, operating room personnel and similar personnel to prevent contamination between the healthcare or similar personnel and the patient's body, fluids, waste, or environment.

Device Description

Class I natural rubber latex surgeon glove, 79 KGO, powdered with absorbable dusting powder, hypoallergenic, that meets all of the requirements of ASTM standard D3577-91.

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K Number

K960407

Device Name

COMFIT ORTHOPEDIC

Manufacturer

WEMBLEY RUBBER PRODUCTS (M) SDN BHD

Date Cleared

1996-04-26

(88 days)

Product Code

KGO

Regulation Number

878.4460

Intended Use

The gloves are intended to be worn on the hand of healthcare personnel, operating room personnel and similar personnel to prevent contamination between the healthcare or similar personnel and the patient's body, fluids, waste, or environment.

Device Description

Class I natural rubber latex surgeon glove, 79 KGO, powdered with absorbable dusting powder, hypoallergenic, that meets all of the requirements of ASTM standard D3577-91. COMFIT ORTHOPAEDIC brown surgical gloves are 0.30 mm (minimum) thick single wall at finger and palm areas to reduce damage from contacting bone, screws, wires or instruments.

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