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MASK14-3 Three Pack Blue Disposable Single Mask Particulate Respirator 3 Layer High Filtration

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SKU:
MASK14-3
UPC:
802074010004
Weight:
0.50 Ounces
Shipping:
Calculated at Checkout
  • MASK14-3 Face Mask is built to cover the mouth, nose and chin while providing a comfortable and soft experience
  • Breathable blue filter masks designed for allergy prevention and is 3-ply disposable face covering
MSRP: $6.60
$4.99
— You save $1.61

Description

MASK14-3 Three Pack of a three ply disposable protective multi-use face mask. Made of top quality materials. This 3 ply Face Mask fits nearly any face size with an elastic stretch ear loop and adjustable embedded nose clip. This 3 ply Face Mask is built to cover the mouth, nose and chin while providing a comfortable and soft experience. This  ear loop mask provides Breathable Fabric filtration. This 3 Ply Design is great for daily use to guard against airborne substances such as pollen, dust, smoke, air pollution and much more. Pack comes with 3 masks. We also carry larger packs such as the 50 piece Disposable 3 Ply Ear Loop Breathable Face Guard Masks. Single use disposable mask.

  • GOOD QUALITY FILTER MASK - Make of safety medical standard material.
  • SAY GOODBYE TO DUST - When working outside,our face masks filter out allergens that can aggregate airway disease
  • BREATHE WELL - Breathable design allergy mask, 3-ply disposable face mask, you can still carefree breathing.Each mask is individually package
  • SOFT AND COMFORTABLE - They are soft and comfortable ear hook masks, not easy to drop, no need to adjust it when you work
  • GREAT VALUE - Big value face mask, Suitable for people: Cleaner, Builder, Farmer, Doctor, Student, Nurs

CERTIFICATIONS 

Listing No: D378663 Code KHA Device name MASK SCAVENGING

Instructions How To Use:

  1. Open the mask from the container.
  2. The white side of face mask to the face, nose strip at the top.
  3. Hang on the ears.
  4. Adjust the mask size, will be carried out under the mask, completely cover the nose and mouth.
  5. Use both hands to regulate the binding bridge of the nose bridge of the nose on both sides of the face mask.

Inner and outer fluid resistant layers.

  • Material: Non-woven Fiber Fabric
  • Elastic Soft Ear-loops
  • Measurement: 7"L x 3.5"W ( Un-expanded)
  • Comfortable, Breathable, Soft and Skin-friendly, and Easy to use
  • All sizes are approximate measurements

MASK-14

3 Ply Disposable Mask FDA Description

Device

mask, scavenging

Regulation Description

Scavenging mask.

Regulation Medical Specialty

Anesthesiology

Review Panel

Anesthesiology

Product Code

KHA

Premarket Review

Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices (DHT1C)

Submission Type

510(K) Exempt

Regulation Number

868.5590

Device Class

1

Total Product Life Cycle (TPLC)

TPLC Product Code Report

GMP Exempt?

No

Summary Malfunction
Reporting

Eligible

Note: FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996. It is important to confirm the exempt status and any limitations that apply with 21 CFR Parts 862-892. Limitations of device exemptions are covered under 21 CFR XXX.9, where XXX refers to Parts 862-892.

If a manufacturer's device falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-892, a premarket notification application and fda clearance is not required before marketing the device in the U.S. however, these manufacturers are required to register their establishment. Please see the Device Registration and Listing website for additional information.

Implanted Device?

No

Life-Sustain/Support Device?

No

Third Party Review

Not Third Party Eligible

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Warranty Information

This unit is warranted to be free from material and workmanship defects for a period of thirty (30) days from the date of original purchase. Supplier's limit of liability under this warranty is to repair or replace the product at Supplier's option. Consequential costs such as, but not limited to, loss of use, loss of time or freight charges are not covered. Any product that has been abused, altered, tampered or incorrectly operated is not covered. Product finish is excluded from this warranty. No other warranties are expressed or implied. We reserve the right to make changes in design, materials and specifications without prior notice.
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