Description
MASK-14 is a three ply disposable protective multi-use mask.
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 |
Contents: 50 disposable 3-ply pleated face masks with ear loops
Storage Requirements: 59° – 86° F
- Comfortable fitting and easy breathing
- High BFE and PFE filtration
- High elasticity ear hook
- Suitable for sensitive skin
DAILY USE: Disposable face masks act as a protective barrier to prevent splashes, sprays, large droplets or splatter from entering the wearer’s mouth and nose. Disposable face masks also help prevent the wearer from spreading respiratory droplets.
ONE SIZE FITS MOST:
- Before putting on a mask, clean hands with soap & water or an alcohol based sanitizer
- Cover mouth and nose with mask and make sure there are no gaps between your face and the mask
- Avoid touching the mask while using it; if you do, clean your hands with soap & water or an alcohol based sanitizer
- Replace the mask with a new one as soon as it is damp and do not re-use single-use masks.
3-LAYER PROTECTION: Non-woven fabric outer layer, high density filter layer & skin friendly contact layer
SUITABLE USE: Ideal for running errands and visiting public areas such as grocery stores, pharmacies, parks, post offices and more where social distancing may be more difficult to maintain
