Supplied as a flat clear plastic sheet with pre‐cut tabs and fold lines. To: Manufacturers of Surgical Masks; N95 surgical respirator -the polypropylene and meltblown materials -are also identical or similar to all of the following predicate devices: the NIOSH-certified Type N95 3M 1870 N95 Health Care Particulate Respirator and Surgical Mask (K063023), and the BioFriend Tm BioMask TM surgical Filtration Performance of FDA-Cleared Surgical Masks 3M Infection Prevention Surgical Masks and Respirators Procedure Masks Black antiglare strip 3M™ Standard Procedure Mask 1826 Premium Quality Premium Comfort Breathability Filtration 3M™ High Fluid-Resistant Procedure Mask 1840 Anti-fog face shield black antiglare strip Surgical & Specialty Masks Procedure Masks 3M Health Care 3M Center, Building 275-4W-02 St. Paul, MN 55144-1000 U.S.A. 1 . PDF g filligent KT-. Funding Information 2.1. That lack of standardized testing and labeling has left mask users with no way to compare face covering products to make . Topstitch along the bottom edge. COVID-19: Non-Medical Masks Page 1 of 9 FREQUENTLY ASKED QUESTIONS COVID-19: Non-Medical Masks First Revision: May 14, 2021 Introduction The Public Health Agency of Canada (PHAC)'s guidance regarding non-medical (cloth) masks (NMMs)1 recommends that NMMs should be made of multiple layers using materials that are breathable, including: 3M™ Health Care Particulate Respirator and Surgical Mask 1860, 1860S User Instructions (PDF, 233.8KB) Instructions 1860, 1860S Particulate Respirator and Surgical Mask (PDF, 71.6KB) Such masks are not a replacement for other recommended precautionary measures. For dated • The face mask is suitable for therapeutic use such as for surgical, clinical, medical use, or use in other health services. U.S. Department of Health and Human Services protection of an N95 respirator and the splash and spray protection of a surgical mask. surgical masks - specialty - pleat-style with ties typeCode items/box boxes/Case So SoFt* surgical mask, white ii 48390 50 6 Fog-free surgical mask, foam band, blue ii 49214 50 6 Anti-fog surgical mask, film strip, green ii 49235 50 6 6. Masks. 3M™ Health Care Particulate Respirator and Surgical Mask, 1860S, N95 Small Technical Specifications (PDF, 225.3KB) 1860 & 1860S Package Appearance, Shelf Life Markings (PDF, 495.8KB) 3M™ Health Care Particulate Respirator and Surgical Masks Storage Conditions and Shelf Life FAQ (PDF, 142.6KB) 4.1 Marking ± In addition, the following information shall be clearly and indelibly marked on Surgical face mask: Repeat the sewing for the lining pieces. labelling, advertising, or documentation contain the claims above, the face mask is considered to be a medical device and is required to be included in the ARTG. Adult masks have uniform size specifications. Patients should be masked during transport. If the manufacturer's labelling, advertising, or documentation contain the claims above, the face mask is considered to be a . For information ClearMask face masks have not been assessed for bacterial filtration efficiency, to determine source protection from the wearer to the patient, as a surgical mask. 1 A surgical mask is a mask that covers the user's nose and mouth and provides a physical barrier to fluids and particulate materials. Unlike respirators and surgical masks, the masks worn to help prevent the spread of COVID-19 don't have to meet federal standards to confirm their performance. 2 Normative references: The following referenced documents are indispensable for the application of this document. Align the center seam line and pin the pieces. Here are five steps for partnering with your local hospital to produce surgical masks and shields. Surgical masks should be discarded; face shields should be cleaned and disinfected. Fluid resistant masks (surgical masks): • EN 14683 Type IIR • ASTM F2100 Level 1, 2 or 3, • YY 0469, with at least 98% bacterial droplet filtration They are tested according to a set of standardized test methods (ASTM F2100, EN 14683, or equivalent) that aim to balance high filtration, This is due to the design shown below: On the mask production line, there is a folding device to achieve this purpose. . the surgical mask and not be pulled through the filter material of the mask. Company Name Dynarex Corporation Telephone (888)-DYNAREX (Mon - Fri) At other times, contact the local Poison Control Center MSDS Issued 5/29/12 Updated 1/28/13 Turn the face mask right side out. 5. or seal (e.g., surgical mask, face shield) over the respirator. 49310 62363 48207 48247 47107 62113 . Dynarex - Ear-loop surgical mask is a blue pleated ear-loop procedure mask with glass-free filter. Schedule of the licence, shall be suitably marked on each Surgical Face mask and its container, provided always that the Surgical face mask to which this mark is thus applied, conform to every requirement of the specification. The 1860 and 1860S particulate respirators are personal protective equipment (PPE) that are primarily intended to protect the health care workers by reducing exposure to The difference in PFE between N95 and surgical masks becomes much less pronounced if there is a lack of a proper seal/fit and leakage occurs. Standard surgical masks are as effective as respirator masks (e.g. mask is rated (i.e., 1, 2, or 3 specifications). c. Remove the respirator and either hang it in a designated area or place In contrast to a thin, single-layered or double-layered paper mask, a surgical mask usually consists of three layers of flat or pleated fabric. Sanitary / hygienic products are meant to provide protection against various forms of biological contamination. The 1860 particulate respirator is a personal protective equipment (PPE) that is primarily intended to protect the health care workers by reducing exposure to harmful airborne particles which are small enough to be inhaled . Remove the barrier upon leaving the patient's room and perform hand hygiene. These products are approved by NIOSH as N95 respirators and Powered ventilation uses a built-in (e.g. Fabric straps are fixed on the mask, no loose. Ideal for protection from possible contamination. Directions for use: 1. In this document edical masks arem defined as surgical or procedure masks that are flat or pleated (some are shaped like cups); they are affixed to the head with straps . Respiratory protective masks are commonly referred to as N95 masks but the FFP2 is also a respiratory mask. N95 specification respirators Reusable Disposable Nonsurgical Half face respirator Surgical mask Full facepiece ASTM Level 11 Surgical PAPR respirator Filtration efficiency ≥99.97% 2 ≥95% 2 ≥95% 2 ≥95% 2 ≥95% 2 BFE ≥95%; PFE ≥95% 3 Fluid protection resistance >120 mm Hg >80 mm Hg N/A N/A >120 mm Hg >80 mm Hg Breathability . Title: Microsoft PowerPoint - Face Masks Author: ssmit Created Date: 10/29/2019 1:23:28 PM Surgical Mask - Loose fit creates . ANNEX F. TECHNICAL SPECIFICATIONS FOR SURGICAL MASKS AND HYDROCEPHALUS VALVES 1. 4. b. This product may be used in settings where exposure to liquid or bodily fluids may be expected. Surgical masks — Specification 1 Scope This Kenya Standard specifies materials, composition, type, workmanship, design, size, test methods, labeling, and packaging of surgical masks. Other. The 3M™ Aura™ Health Care Particulate Respirator and Surgical Mask 1870+ has comfortable inner materials and helps provide respiratory protection against certain airborne particles. Title: Import basic Checklists Author: Sofeast Subject . At the airflow rate of 8 L/min, intact N95 and surgical masks had very different total inward leakage (TIL) of 0.31% and 3.58%, respectively . Feature. 1 April 2021. Hospital Setting 1.1Screening Area : All medical personnel including nursing and paramedical staff would use Disposable Triple layer surgical mask while interacting . No head to head trial of these masks in COVID-19 has yet been published, and neither type of mask prevents all infection. The individually packaged flat fold design allows for convenient storage prior to use. Surgical masks showed penetration levels of approximately 55-85% and 70-90% at flow rates of 30 and 100 liters/minute, respectively, for 300 nm particles. 2.glass fibre free. CONTROL UNIT - For the purpose of this scheme, all surgical masks of the same class Only surgical masks that are cleared by the U.S. Food 3-ply Surgical Mask Generic Checklist. Damaged or soiled particle filtering half masks or particle filtering half masks where the expiration date has elapsed must not be used. ANNEX F. TECHNICAL SPECIFICATIONS FOR SURGICAL MASKS AND HYDROCEPHALUS VALVES 1. Mask, medical - for healthcare worker Medical mask, good breathability, internal and external faces should be clearly identified, 98% droplet filtration, preferably fluid resistance. 1. N-95 Respirator mask An N-95 respirator mask is a respiratory protective device with high filtration efficiency to airborne The TIL refers to all aerosols that pass through the mask . Place the mask and lining right sides together. Check expiration date. Fluid resistant masks (surgical masks): • EN 14683 Type IIR• ASTM F2100 Level 1, 2 or 3,• YY 0469, with at least 98% bacterial droplet filtration or alternative equivalent standard Overview of The ASTM F3502-21 Barrier Face Covering Standard. South Africa. Fluid resistant masks (surgical masks): • EN 14683 Type IIR • ASTM F2100 Level 1, 2 or 3 • YY 0469, with at least 98% bacterial droplet filtration • Or alternative equivalent standard Facilities should provide N95 or higher-level respirators, and fit-testing (passing a fit-test is needed for the respirator to be protective to airborne diseases), to their staff. Nifty list. wear surgical masks for close contact and, if substantial spraying of body fluids is anticipated, gloves and gown as well as goggles (or face shield in place of goggles). How does it ensure that different people have the right size requirements to ensure that the nose, mouth and chin are wrapped to the greatest extent? the PROCUREMENT OF SURGICAL MASK FOR CY 2021 with identification number ITB No. Surgical masks were found to be less efficient compared to dust-mist (DM) and dust-mist-fume (DMF) respirators. A high quality, general use, surgical face mask. Surgical masks — Specification 1 Scope This Kenya Standard specifies materials, composition, type, workmanship, design, size, test methods, labeling, and packaging of surgical masks. Conforms to specifications Function test Product & Unit . Zhangxin Zheng | May 20, 2021, 10:23 PM . Respiratory protective masks are commonly referred to as N95 masks but the FFP2 is also a respiratory mask. Product Name Face Masks Product Code 2201, 2202, 2205, 2206, 2208 Use(s) of substance/preparation For protection from possible contamination. Adjustable, good toughness, good nose shaping, no leakage. Surgical Mask" issued January 16, 1998. Press seam neatly. DOST-PTRI and DOH Recommended Specifications for Non-Medical Face Masks for Community Use Philippine Textile Research Institute Department of Science and Technology Public Health Services Team Department of Health 1 Properties Minimum specification (Test Method a) 1) Material+ a) Composition Cotton, Cotton-blends, Polyester, Polypropylene, PET . battery) energy source to move air, and can operate small cooling fans to produce forced-air for more-comfortable breathing. A medical face mask (also known as surgical or procedure mask) is a medical device covering the mouth, nose and chin ensuring a barrier that limits the transition of an infective agent between the hospital staff and the patient. SBP212C. gaps where particles can enter. Events. All classes of medical devices need Surgical Molded Utility Mask Physical Barrier Only No LEVEL Performance Level ** Filtration E! Requirements and Test Methods China Product Standards Masks that fall into the following three Chinese standards are categorized as medical masks: GB 19083, YY 0469, and YY / T 0969. 2. SURGICAL N95 RESPIRATORS. Latex free. 8. See Appendix I for mask specifications Mask Style Pleated Secure-Gard Surgical Mask Pleated Secure-Gard Procedure Mask Pleated Design Features KC0300 Surgical Mask Secure-Gard Surgical Mask Fluidshield Fog-Free AT74535 -Anti-fog foam strip and Ties AT74635 -Anti-fog foam strip, Eye shield, and Ties AT74635-1 -Anti-fog foam strip, Schedule of the licence, shall be suitably marked on each Surgical Face mask and its container, provided always that the Surgical face mask to which this mark is thus applied, conform to every requirement of the specification. SURGICAL MASKS LATEX FREE BOX OF 150 General Description Surgical masks latex free, fiber glass free, hypo-allergic, with ear loops and nose piece, Box of 50 Synonym: Procedure /face masks Intended Use: Surgical mask is intended to be worn by medical personnel during 2021-06. Specs 1 pc Report quantity and breakdown inside export cartons. N95, FFP2, FFP3) for preventing infection of healthcare workers in outbreaks of viral respiratory illnesses such as influenza. 3) Folding mask. Facemask—A loose-fitting, disposable device that creates a physical barrier between the mouth and As a surgical mask, it is designed to be fluid resistant to splash and spatter of blood and other infectious materials. Medical mask, good breathability, internal and external faces should be clearly identified, 98% droplet filtration, preferably fluid resistance. 32 (AQL 4% sampling plan required for ASTM F2100, each sample must be 5 x 5 inches (12 x 12 cm) minimum or full face mask; specify particle size when submitting samples (0.1 for ASTM F2100, 0.3, 0.5 or 1.0 micron) x 3 non-consecutive lots. Grasp nosepiece at top of mask with one hand. TEST CERTIFICATE- Each consignment of surgical face masks shall be supplied with a certificate to the effect that the units being supplied have been tested as per the requirements of the specification and found suitable for use. 4.1 Marking ± In addition, the following information shall be clearly and indelibly marked on Surgical face mask: 4.1.2.2. • The face shield is intended for medical use with surgical mask or respirator. AQL 4%: (32 x 3 = 96 total masks) 21 calendar days. 1. Review the pattern and specifications for producing PPE. Cleared by the FDA. As surgical masks, they are designed to be fluid resistant to splash and spatter of blood and other infectious materials. Strap ends are neatly trimmed. A surgical N95 respirator provides the respiratory . The PROCUREMENT OF SURGICAL MASK FOR CY 2021 (referred to herein as "Project") is composed of ONE (1) LOT, the details of which are described in Section VII (Technical Specifications). The face mask is suitable for therapeutic use such as for surgical, clinical, medical use, or use in other health services. Here's a list of HSA-approved surgical masks with 95% bacterial filtration efficiency. Box of 50. Color: Blue. PRODUCT SPECIFICATIONS This product is manufactured in compliance with the FDA Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised). 100 MILLION MASK CHALLENGE AHA.ORG/100MILLIONMASKS #100MillionMasks . Synthetic Blood Penetration for Face Masks . A surgical mask is a loose-fitting, disposable device that creates a physical barrier between the mouth and nose of the wearer and potential contaminants in the immediate environment. If governments were to purchase bulk supplies of cloth masks for community use, the specifications likely to correspond with greatest effectiveness include: 2-3 layers, preferably of different fabrics; fabrics South Africa. surgical mask to wear when you enter the emergency department or general practice. SURGICAL MASKS LATEX FREE BOX OF 150 General Description Surgical masks latex free, fiber glass free, hypo-allergic, with ear loops and nose piece, Box of 50 Synonym: Procedure /face masks Intended Use: Surgical mask is intended to be worn by medical personnel during 1860-1860S User Instructions (PDF, 233.8KB) 1860 & 1860S Package Appearance, Shelf Life Markings (PDF, 495.8KB) 3M™ Health Care Particulate Respirator and Surgical Masks Storage Conditions and Shelf Life FAQ (PDF, 142.6KB) Tech Spec 3M Healthcare Particulate Respirator and Surgical Mask 1860, N95 (PDF, 2.2MB) Technical Specifications Description: One‐size‐fits‐all, lightweight medical face shield. 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