Description
MASK-14 is a single disposable masks. The MASK-14 is a three ply disposable protective mask These are designed as single use disposable mask with high fluid and respiratory protection.
MASK-14 has inner and outer fluid resistant layers for even better protection.
- 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 the MASK-14:
- 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 |
