FUJIAN MEIDE KN95-001 USER AND CERTIFICATION INFORMATION

FUJIAN MEIDE KN95-001 RESPIRATOR


Manufacturer: Fujian Meide Medical Device Manufacturing Co., Ltd.

Manufacturer Address: No. 1, Heping Rd, ShiTing, Hanjiang District, Putina, Fujian, China

Manufacturer website:https://www.interestprint.com/mask-KN95-001

Quality statement: Fujian Meide Medical Device Manufacturing Co., Ltd. is a certified manufacturer according to international standards ISO9001 and ISO13485


Respirator Model number: KN95-001

Testing and standards certification: GB2626:2006: KN95


USE AND FITTING INSTRUCTIONS

BIOCOMPATIBILITY INFORMATION:

STANDARDS CERTIFICATION

ADVERSE ISSUES ADVISORY:


USE AND FITTING INSTRUCTIONS: MODEL FUJIAN MEIDE KN95-001 RESPIRATOR.

Version control. Version date 2020-05-04. Refer to manufacturer website (below) for most up-to-date information.

General description. This respirator is type KN95 according to standard GB2626:2006. The use of this respirator is subject to authorization in accordance with prevailing government standards and rulings in respective jurisdictions.

Use and warnings: This respirator is for use for protection against non-toxic dusts in dry, non-poisonous, non-flammable atmospheres.

Do not use the respirator if:

a) It is damaged

b) If it is wet

c) In a flammable or poisonous gas atmosphere.

d) In oily particle or aerosol environment

e) In atmospheres of under 19.5% oxygen

f) If it has not been properly fitted according to instructions below.

g) If user is unable to breathe comfortably through the respirator.

h) If the user has facial hair that prevents sealing of respirator to user's face.

i) If it is beyond the expiration date printed on the package.

Do not use the respirator in environments for which it is not approved by prevailing government standards and rulings.

Fit testing. It is necessary for user to ensure proper fit and seal of respirator before entering work or potentially hazardous area.

Start in a safe, non-hazardous and clean area.


1. Inspect package and confirm date validity.

2. Carefully remove respirator from sealed package and inspect for damage, and check security of straps.

3. With clean hands, or gloves, pick up respirator with nosepiece facing away from you. Open respirator into cup shape and pinch lower seam so that lower edge forms a smooth curve that can conform to chin.

4. With open side of cupped respirator towards face, hold earloop straps, one in each hand and pull each strap over respective ear.

5. With fingertips press metal nose brace at top of respirator on either side of nose, pressing towards face so that metal brace bends and conforms to nose bridge and forms good seal. Do not pinch brace across nose, as this will likely cause less effective seal.

6. Before entering work or potentially hazardous area, check the seal of the respirator on the face by breathing in and out as follows:

7. Breath out strongly. If air leaks adjust the position or respirator, and if necessary, adjust the bend of the nose brace.

8. This is a standard sized respirator. For small users, if air leaks at the respirator edges, tighten the ear loop straps by tying a knot securely in both ear loops to reduce each length by 1 to 3 cms (0.4 to 1.25 inches). Pull knots tight before final donning.

9. Breathe in a slow deep breath. If air leaks around edges of respirator, adjust respirator position, shape of nose brace, and if necessary, shorten ear loops as above.

10. Take enough time to ensure comfortable fit, so that you will not be inclined to adjust respirator during use. If adjustment is needed, first move away from potential hazards and use clean hands or gloves.

11. If respirator is removed temporarily, fitting instructions and seal testing should be followed upon re-donning.


Manufacturer information.

Model Number: KN95-001

Manufacturer: Fujian Meide Medical Device Manufacturing Co., Ltd.

Manufacturer Address: No. 1, Heping Rd, ShiTing, Hanjiang District, Putina, Fujian, China

Manufacturer Website:https://www.interestprint.com/mask-KN95-001

Telephone: +86-594-3791888

STATEMENT OF BIO-COMPATIBILITY FUJIAN MEIDE KN95-001 RESPIRATOR

The type KN95-001 respirator does not include components made of natural latex rubber,

The construction is 5-layers:

· Outer layer (away from user): non-woven fabrics

·  Intermediate layer A: melt-blown fabrics

·  Intermediate layer B: cotton filter fabrics

·  Intermediate layer C: melt-blown fabrics

· Inner layer (closest to user): non-woven fabrics

The ear loop straps are made from: polypropylene

The nose brace is aluminum metal.

Fujian Meide Medical Device Manufacturing Co., Ltd.

2020-04-20

ADVERSE ISSUES NOTIFICATION FUJIAN MEIDE KN95-001 RESPIRATOR

The manufacturer will publish reports of know adverse issues relating to this respirator here:

DATE /ISSUE TITLE /ISSUE DESCRIPTION /STATUS

No known issues at this time

Manufacturer will advise US FDA of known issues.

Manufacturer: Fujian Meide Medical Device Manufacturing Co., Ltd. Fujian, China


STANDARDS CERTIFICATION FUJIAN MEIDE KN95-001 RESPIRATOR

The type KN95-001 respirator has been tested to the following standards by independent testing laboratories:

1/. Performance Standard: GB2626:2006 KN95.

Tested by: Zhejiang Light Industrial Products Inspection and  Research Institute

Test Laboratory website: www.zjttj.cn:807

Certificate number: W202011493E

Issue date of the report: 2020-04-26

Requester: Fujian Meide Medical Device Manufacturing Co., Ltd

Requester Address: No.1 Heping Rd, Shiting, Hanjiang District, Putian, Fujian, China

Results: Meets standard in all categories of test. (Refer to test certificate for details).

2/. Quality Standards: ISO9001, ISO13495

3/. Quality and authenticity control. Each package of respirators contains statement of production batch identification, date and conformance.

Fujian Meide Medical Device Manufacturing Co., Ltd..

2020-05-04