Audited Supplier
| Style | earloop |
| Size | 17.5*9.5cm |
| Material | 3ply: SBPP,MB,SBPP |
| Certification | FDA 510K, CE, ISO13485 |
| Structure | without face visor |
| Type | without soft foam |
| Nose clip | double wire |
Specification:
1.Conform to FDA 510K (No:K101000).
2. Glass fiber-free and latex-free.
3. Breathing Resistance (Delta P)<6.0.
4.Bacterial Filtration Efficiency (BFE%) >99%
5.Particle Filtration Efficiency(PFE%)>99%.
6. Synthetic Blood Penetration Resistance: 160mmHg.
Packing:
| Normal Packing | QTY (pc) | Carton Size (cm) | N.G (kg/ctn) | W.G (kg/ctn) | Prodution Time |
| 50pcs/box 40boxes/ctn | 200,000 | 52X40X36 | 7.5 | 8.5 | 10 |
| 700,000 (1X20GP) | 15 | ||||
| 1,440,000 (1X40GP) | 20 | ||||
| 1,720,000 (1X40HQ) | 20 | ||||
Remark: Production time is based on quantity and the time of order confirmation. | |||||
Shipping Port: Shanghai or Wuhan.
Packing Picture:
Remark: To better ensure the safety of your goods, professional, environmentally friendly, convenient, and efficient packaging services will be provided.
Wellmien Performance for Surgical Face Mask ASTM Level 3 Non-Woven FDA510K:
Standard Class | Breathing Filtration Efficiency (BFE) | Breathing Resistance (mmH20/cm2) | Splash Resistance | Particulate Filtration Efficiency (PFE) |
FDA 510K | >99% | < 6,0 | 160 | >99% |
FDA 510 K Requirements:
| MEDICAL FACE MASK TESTS AND REQUIREMENTS U.S.A.: ASTM F2100-19 STANDARD SPECIFICATION FOR PERFORMANCE OF MATERIALS USED IN MEDICAL FACE MASKS | ||||
| Test Item | ASTM F2100-19 | |||
| Level 1 | Level 2 | Level 3 | ||
| Barrier Testing | BFE% ASTM F2101 | ≥95 | ≥98 | |
| PFE% ASTM F2299 | ≥95 | ≥98 | ||
| Synthetic Blood ASTM F1862 | Pass at 80mmHg | Pass at 120mmHg | Pass at 160mmHg | |
| Physical Testing | Differential Pressure | <5.0 mmH2O/cm³ | <6.0 mmH2O/cm³ | |
| Safety Testing | Flammability 16 CFR Part 1610 | Class 1 (≥ 3.5 seconds) | ||
| Microbial Cleanliness ISO 11737-1 | Not required | |||
| Biocompatibility ISO 10993 | 510 K Guidance recommends testing to ISO 10993 | |||
| Sampling ANSI/ASQC Z1.4 ISO 2859-1 | 1. AQL 4% for BFE,PFE, Delta P 2. 32 masks for Synthetic Blood (Pass=≥29 passing, Fail=≤28 passing) 3. 14 masks for Flammability | |||
[Scope of Application]: It covers the user's mouth, nose, and jaw to provide a physical barrier against the direct penetration of pathogens, microorganisms, body fluids, particles, etc.
[Raw Materials, Structure, and Composition of the Product]:
The product consists of a mask body, a nose clip, and a mask band. The mask body is divided into three layers: inner and outer layers are polypropylene (PP) non-woven cloth, and the middle layer is polypropylene (PP) melt-sprayed cloth. The nose clip is made of galvanized iron wire with PE material. The masked band is spandex.
[Product Contraindications]: None.
[Usage]:
How to wear the mask:
- The dark side of the mask should be worn on the outside, while the light side should be close to the mouth. The nose clip should be put on the nose, and the mask should cover the nose and mouth. Two elastic ear-loops hang on each ear.
- Put the fingertips on the nose clip, start from the middle, press onward with the fingers and gradually move to both sides, and shape the nose clip according to the shape of the bridge of the nose;
- Adjust the mask belt appropriately according to personal comfort.
a)Do not touch the front of the mask (contaminated surface).
b)Remove elastic bands from both ears.
c)The elastic band used to hold the mask only is thrown into the clinical waste container.
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