FDA / CE certified medical goggle

Material

Polycarbonate

Function

anti-fog, Splash proof, Anti-impact, Anti-dust, Anti-virous, Anti-UV

Operating Environment

Temperature: 10 to 40°C (50 to 104.0ºF)
Humidity: 20%-85% RH, non-condensing
Atmospheric pressure: 86kPa – 106kPa

Storage & Shopping Environment

Temperature: -20 to 55°C (-4 to 131ºF)
Humidity: 20%-93% RH, non-condensing
Atmospheric pressure: 86kPa – 106kPa

N.W.

62g

Dimension

150*45*130mm

1、Product name: Medical goggle

2、Model / Specification: MG01

3、Structure composition of products

The medical goggle comprises protective shields made of polymer materials

and the fixing device. Non-sterile, disposable use.

4、Intended purposes

The product is used for protection and blocking the spatter or splash of bodily

fluid and blood at the time of inspection and treatment in the medical institution.

5、Product performance

5.1  Appearance and Structure

a) The surface of the protective shield should be smooth, colorless and

transparent without burr or sharp angle and should not cause eye and face

discomfort when wearing.

b) The surface of the lens shall be flat, smooth and free of scratches, ripples,

bubbles, impurities or other obvious defects that may impair vision.

c) Adjustable parts or structural parts shall be easily adjustable or replaced. The

headband should be elastic.

5.2.Specification

a)、The size of goggles shall be in accordance with the manufacturer’s

requirements with an error not greater than ±10%.

b)、The width of the headband should be larger than 10mm. The length shall be

adjustable and the range shall be in accordance with the requirements of the

manufacturer.

c)、Designs should conform to the ergonomics and guarantee good fitting with

the face.

5.3.Material

a)、The parts in contact with the user should not use materials that cause skin

irritation.

b)、Lens material should use anti-fogging material or add anti-fogging coati

5.4.The visible light transmittance of the lens

The materials used in the field of view (mirror area) should have a well

visible light transmittance, and the visible light transmittance should not be less

than 90%.

5.5.Anti-fall performance

If the Goggle falls freely with three different kinds of starting postures from 1m

height onto a hard surface, its structural parts should not peel off, its appearance

should not be damaged, and the lens should be without cracks.

5.6.Impact resistance

The lens and protective shield shall be able to withstand the impact of a steel

ball with a diameter of 22mm and a weight of about 45g falling freely from a

height of 1.3m.

5.7.Heat resistance

The goggles should be insulated at 67°C±2°C water for 3min without

deformation.

6、Contraindications and precautions

6.1.Contraindications: No

6.2 Precautions:

1) If itch, rash or blister appears during use of the product, the user should

stop using the product in severe conditions;

2) The product is disposable and should not be reused.- 5-

3) Please put it into the medical waste bin after use and don’t throw it about.

4) The shape of the instrument is subject to change without prior notice.

7、 Use method:

Tear the package, hang the band on your ears and wear this product on your

eyes.

8、 Storage condition

1) Temperature: 0°C~45°C;

2) Humidity: The relative humidity does not exceed 80%;

3) Clean and dry places with good ventilation and without corrosive gases.

9、The date of production/batch number is shown in the label: The validity term of

the product is two years.