CE and FDA 510k Approved Surgical Disposable Masks
Packing: 50pcs/box, 40boxed/ctn
Delivery time: 15-30days after receipt of deposit payment
Shipping Port: Shanghai
Our Services
1.Sample according to your design drawing. Sampling time:3-5days .
2. Design your own sample, then remake it.
3. Existing Samples Sampling time:1day
4. Make mass production after your confirm the sample.
Company Profile
Founded in 2006
Specialized in disposable medical & PPE products
Own 1500 m2 of clean room
Provide OEM service
Annual sales revenue > USD 10 million
ISO 13485 certificated
FDA registered
510K approved (No: K101000)
CE certificated
Our Advantage:
1.FDA, FDA 510K, CE, ISO13485 certification.
2.One-stop service :excellent disposable medical products ,personal protection equipments.
3.Welcome any OEM requirements.
4.Qualified products,100% new brand material ,safe and sanitary.
5.Offered free samples .
6.Professional shipping service if necessary.
7.Full series after sales service system.
| Product Description | |
| Name | CE and FDA 510K approved surgical disposable masks |
Structure | 3-ply: SBPP+MB+SBPP with face visor or without with soft foam or without |
Style | earloop |
| Nose clip | single nose wire double nose wire plastic nose clip aluminum nose clip |
Size | Adult: 17.5*9.5cm Child: 14.5*9.5cm |
Color | white/blue/green/yellow/as requested |
Standard Class | Bacteria Filtration Efficiency (BFE) | Breathing Resistance (mmH2O/cm2) | Splash Resistance (mmHg) | Particluate Filtration Efficiency (PFE) | |
FDA 510 (K) | >99% | <5.0 | 120/160 | >99% | |
EN14683 | Type I | >98% | <3.0 | N/A | N/A |
Type IR | >98% | <5.0 | 120 | N/A | |
Type II | >99% | <3.0 | N/A | >98% | |
Type IIR | >99% | <5.0 | 120/160 | >98% | |
Packing: 50pcs/box, 40boxed/ctn
Delivery time: 15-30days after receipt of deposit payment
Shipping Port: Shanghai
Our Services
1.Sample according to your design drawing. Sampling time:3-5days .
2. Design your own sample, then remake it.
3. Existing Samples Sampling time:1day
4. Make mass production after your confirm the sample.
Company Profile
Founded in 2006
Specialized in disposable medical & PPE products
Own 1500 m2 of clean room
Provide OEM service
Annual sales revenue > USD 10 million
ISO 13485 certificated
FDA registered
510K approved (No: K101000)
CE certificated
Our Advantage:
1.FDA, FDA 510K, CE, ISO13485 certification.
2.One-stop service :excellent disposable medical products ,personal protection equipments.
3.Welcome any OEM requirements.
4.Qualified products,100% new brand material ,safe and sanitary.
5.Offered free samples .
6.Professional shipping service if necessary.
7.Full series after sales service system.