Description
MASK14-2 Two 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 2 masks. We also carry larger packs such as the 50 piece Disposable 3 Ply Ear Loop Breathable Face Guard Masks. Single use disposable mask.
High fluid and respiratory protection.
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
- Made through Ultra-Sonic technology for added strength and reliability
- All sizes are approximate measurements
CERTIFICATIONS
Listing No: D378663 Code KHA Device name MASK SCAVENGING
Instructions How To Use:
- Open the mask from the container.
- The white side of face mask to the face, nose strip at the top.
- Hang on the ears.
- Adjust the mask size, will be carried out under the mask, completely cover the nose and mouth.
- Use both hands to regulate the binding bridge of the nose bridge of the nose on both sides of the face mask.
MASK-14
3 Ply Disposable Mask FDA Description
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Device |
mask, scavenging |
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Regulation Description |
Scavenging mask. |
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Regulation Medical Specialty |
Anesthesiology |
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Review Panel |
Anesthesiology |
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Product Code |
KHA |
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Premarket Review |
Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1) |
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Submission Type |
510(K) Exempt |
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Regulation Number |
|
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Device Class |
1 |
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Total Product Life Cycle (TPLC) |
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GMP Exempt? |
No |
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Summary Malfunction |
Eligible |
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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. |
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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. |
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Implanted Device? |
No |
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Life-Sustain/Support Device? |
No |
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Third Party Review |
Not Third Party Eligible |
