Color: Blue, Yellow, Green or as requested
Size: 17.5X9.5cm,
Material: SBPP,MB,SBPP
Sales Model: Wholesale
MOQ: 200000PCS
Style:Earloop
Product: ASTM Level 3 Surgical Face Mask Disposable Non Woven FDA 510K BFE 99%
| 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 (day) |
| 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 ASTM F 2100 Level 3 | >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 | Flammablility 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 | |||
