SS9001-N95 Disposable Particulate Respirator
Short Description :
Product Name : N95 Disposable Particulate Respirator
Brand : SHINING STAR
Model : SS9001-N95
Wearing Style : Headband
Color : White
Material : Polyester, Electric Static Meltblown
With Valve : No
Standard : NIOSH N95, TC-84A-8084
Packing : 20PCS/BAG/BOX, 12BOX/CTN
SH9550 Series N95 Particulate Respirator
Polypropylene (P.P.) outer layer provides smooth lining and avoids loose fibers.
Embossed fringe seal avoids fluffy open layer around the edges.
Latex-Free synthetic rubber headstrap.
Contour design ensures the compatibility of glasses/goggles and reduces fogging.
Soft closed-cell nose foam and adjustable nosepiece ensure custom shape and increase the worker comfort and acceptance.
Our 9500 series of NIOSH approved respirators is the "standard" for all the industries in which these products are used. This is the basic N95 product developed to compete with similar appearing disposable respirators. By far, this cone style of N95 mask is the most widely used mask in all work environments.
It has been designed to easily meet NIOSH's stringent approval requirements for breathing resistance and filtration efficiency. Most companies interested in adding N95 respirators to their line of business will select either our 9500 series or the alternative MK series as the focal point around which to build a disposable respirator line.
These NIOSH approved Makrite Sekura Foldable N95 masks are designed to filter at least 95% of particulate matter. They are extremely durable with a soft and comfortable inner surface. These N95 masks come with an adjustable nose and secured head straps to provide proper fit.
Brand: Makrite
Model: Sekura-n95
NIOSH Approved
Industrial Use Respirator
FDA 510(k) Registered
NIOSH Approval: TC-84A-7638
FDA 510(K) K020474
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WEGO -SOG HEALTH
1ml/1cc with needle 25Gx1 Luer slip OTG LA $0.10 , 20 millions available (April 17, 2021)
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3ml/3cc with needle 23Gx1 Luer lock OTG LA $0.11, 4.5 millions available (April 17, 2021)
Refer Standards
EN ISO 8537:2007 Sterile single-use syringes, with or without needle, for insulin.
EN ISO 9626:1991 / AMD. 1: 2001 Stainless steel needle tubing for the manufacture of medical devices AMENDMENT 1.
ASTM F88/F88M-09 Standard Test Method for Seal Strength of Flexible Barrier Materials.
ASTM F1140/F1140M -13 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages.
ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals.
USP 37- NF32 2014: U.S. Pharmacopeia National Formulary.
Refer Standards
ISO 9626: 1991 + AMENDMENT 1 2001 Stainless steel needle tubing for the manufacture of medical devices.
ISO 8537:2007 Sterile single-use syringes, with or without needle, for insulin.
ISO 10993-7:2008 Biological evaluation of medical devices - Part 7 : Ethylene oxide sterilization residuals.
ASTM F 1140/F 1140M-13 Standard test methods for internal pressurization failure resistance of unrestrained packages.
USP 37-NF 32 <85> Bacterial Endotoxins Limit.
ISO 11737-2:2009 Sterilization of medical devices - Microbiological methods - Part 2: Test of sterility performed in the definition, validation and maintenance of a sterilization process.
ISO 11135-1:2007 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.
Features and Benefits:
Sterile pack, single use only.
Caina patented product.
Color coded for easy identification of needle sizes.
Ultra-sharp needle tip minimizes patient discomfort.
Needle stick prevention, safety assured.
Unique needle lubrication process, most comfort injection.
Mini design for easy carrying.
Red indication for activation.
All materials are latex & DEHP free.
