As a surgical mask, GIKO 1400 is classified as Class II Medical Device under Regulation 21 CFR 878.4040. It is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from the transfer of microorganisms, body fluids, and particulate material. 510(k) Premarket Notification number for Giko 1400 FDA Approved surgical n95 masks is K063334.
GIKO 1400 N95 NIOSH Respirator Overview
GIKO 1400 is NIOSH approved with approval number TC-84A-4282.
As surgical masks in white color, they are designed to be fluid resistant to splash and spatter of blood and other infectious materials according to ASTM F1862.
GIKO 1400 N95 mask for healthcare professionals with duckbill shape suits for most facial sizes with elastic headband and US average size.
Highly efficient filter media which is 95% efficient against a 0.3-micron particulate.
Duckbilled shape medical n95 mask is designed to increase comfort and wearability.
GIKO 1400 n95 respirators and surgical masks come with a white, elastic rubber headband and a closed-cell foam inside nosepiece, and a plastic-coated aluminum outside nosepiece.
Individually wrapped for easy storage.
FDA cleared surgical mask.
ASTM Level 2 F2100 standard.
At least 95% filtration efficiency.
GIKO 1400 n95 surgical masks disposable medical grade FDA approved Certification
GIKO 1400 N95 NIOSH Approval Number TC-84A-4282, approval date 2/22/2006.
GIKO 1400 face mask surgical n95 Details
Size Medium
10pcs per box
Shelf life 2 Years
Alva Moore –
The mask is designed to provide maximum protection against airborne particles, while also being comfortable to wear. The breathable and lightweight design allows me to move around without feeling any discomfort, and the included filters can be easily replaced when needed.The Giko 1400 N95 mask has been a game-changer for me during the COVID-19 pandemic. I have been using it for both personal and professional use, and have found it to be consistently effective in protecting me and my loved ones from the virus. The FGDP approval provides added peace of mind, knowing that the mask has been rigorously tested for both effectiveness and safety.
Gaby –
As a concerned user, I have been looking for high-quality medical equipment that can provide the necessary protection for my family and I. Your product has exceeded all of my expectations in terms of both security and quality.The N95 masks you have approved have a FDA clearance, which is a testament to your dedication to providing safe and effective medical equipment. The masks are designed to provide the same level of protection as a surgical mask, while also being comfortable to wear. This is an essential feature for anyone who needs to be wearing a mask for an extended period of time.
Adam Davis –
I recently purchased the Giko 1400 surgical N95 face mask, and I must say, I’m happy with my purchase. The mask is designed to provide a tight fit and filter out even the tiniest particles in the air, which I can definitely attest to. The mask is made of comfortable material that doesn’t feel restrictive or uncomfortable, and the adjustmentable nose pads help ensure a snug fit for everyone.What really impressed me though, was the affordable price. While I know that investing in high-quality medical equipment is important, the Giko 1400 is an essential tool for protecting myself and my loved ones from the virus, and I’m grateful to have it at an affordable price.
Anthony N. Lewis –
I recently purchased the Giko 1400 surgical N95 face mask, and I couldn’t be happier with my purchase. The mask is made from high-quality materials and has a comfortable fit. The double-layered filter ensures that the air I breathe is clean and safe.What I’m most impressed with is the security features of the mask. The N95 filter is designed to preventviruses和bacteria的传播, and the adjustable air flow system ensures that the mask fits comfortably and securely. The mask is also compatible with a variety of nose and mouth sizes, making it a great option for a range of users.The value for money is also fantastic.
Julia Marsaus –
I have been using the Giko 1400 surgical N95 face mask for a few weeks now, and I am happy with the quality and ease of use. The mask is designed to fit comfortably and does not feel restrictive. The filter is effective in removing the virus and particles from my breath, and the adjustable nosecups provide a snug fit for me. The mask is also easy to clean and maintain. I highly recommend the Giko 1400 surgical N95 face mask to anyone looking for a reliable and comfortable solution for protecting themselves from the virus
Abraham Jones –
As a concerned user, I have been looking for high-quality medical equipment that can provide the necessary protection for my family and I. Your product has exceeded all of my expectations in terms of both security and quality.The N95 masks you have approved have a FDA clearance, which is a testament to your dedication to providing safe and effective medical equipment. The masks are designed to provide the same level of protection as a surgical mask, while also being comfortable to wear. This is an essential feature for anyone who needs to be wearing a mask for an extended period of time.
ROSEMARY H. –
Not very breathable & hot. Nice site.
J.Julliand –
Easy to get good seal.
Alex Goodall –
Lightweight and good fit.
Josie G. –
I’ve tried numerous N95 masks, and these are so comfortable that I have bought several boxes of 20 for my household because COVID started. The cost is greater than the majority of masks, however I ‘d instead pay even more for this sort of convenience considering that I wear them for long durations of time. The mask material is soft as well as also the bands are soft yet tight sufficient to be incredibly safe and secure. The masks are made in the U.S., as well as PHG client service is outstanding. Distribution was instant. I’ve saw that my youngsters wear them a lot longer than various other masks because they are easy and also so comfortable to take a breath in.
DONALD L. –
Great product delivered as stated!
Priscilla –
i think they pretect you
M.G.Safonov –
Super comfortable and breathable –
Victor L. –
Product as described
Jeffrey R. –
Needed feplacements and they work great Overrall good deal.
Ann B. –
Very satisfied with the product. Feel protected
Barry –
Fit good, easy to wear
LINDA S. –
They are very comfortable.
ASGARI S –
Seals tightly around the face. Feels very safe.
Patricia A. –
A heavier product so should stop the germs. My hair obtains entangled in the straps that go over the head. Attleboro as well limited to claim it’s comfortable.
M.Elmasry –
Comfortable to wear all day, indoors or outdoors. Nice site.
NilsJ.Nilsson –
I liked the fit and color
E.Faldella –
It was a gift for my sister, se loves them also.
Celeste –
I like that they are not tight. Thank you.
P.D.Roberts –
It does the job and comfy
S. Velastin –
Work well cover nose and mouth well
Tom Bylander –
So much better fit than a regular surgical mask.
Kimberly M. –
Great fit. Safe filter.
SUSAN G. –
Comfortable fit. Perfect .
Katherine –
Works great still, when needed.
SANDRA W. –
Black, have good shape for face. Last a long time
Erika S. –
My husband likes more than I do
DAMARIS D. –
It was very good, more comfortable.