Tie-On Surgical Masks+Eye Shield

Description

KF-J P01(R)

Application:

KINGFA Tie-on surgical mask with eye shield providing barrier to minimize the direct transmission of infective agent between staff and patients are principally intended for use by healthcare professionals in an operating room and other medical settings with similar requirements. Available with or without an attached face shield.

 

Features:

●99% bacterial filtration efficiency

●Premium materials ensure mask will not lint or tear

●PET eye shield for added protection

●Conformable nose clamp to reduce air leakage

●Ear-loop mask is easy to put on and remove

●Anti-fog treatment provides enhanced clarity

●Provides peripheral protection from splashes

●Specially designed inner facing improves comfort

●Skin friendly, odorless, fiber-glass free and latex-free

 

Quality Standard

●Standard: EN14683:2019+AC: 2019, TYPE IIR

●Product Classification: Class I Medical Device (Annex VIII of the MDR)

 

Material:

●Inner Layer: PP non-woven fabric, 25g/㎡

●Out Layer: PP non-woven fabric, 25g/㎡

●Filter Media: Melt-blown, 25g/㎡

●Face Shield: PET

Performance

●Bacterial filtration efficiency (BFE): ≥98%

●Differential pressure (Pa/cm²):<60

●Splash resistance (kPa): ≥16

●Microbiological Cleanliness（cfu/g）: ≤30

●Flammability: Class 1

Standard Packaging

1.     Exterior Design: 30pcs/box, Size 135*100*300mm

2.     Carton Design : 30boxes/carton, Size 625*425*515mm

3.     Container Loading:

l  20GP: 180 cartons (162,000 units)

l  40GP: 380cartons (342,000 units)

l  40HQ: 475cartons (427,500 units)

 

Manufacturing Accreditations

●ISO 9001 Quality Management System

●ISO 13485 Quality Management System

●QSR820 FDA Quality System Requirements

 

OEM Services

●Product design and development

●Flexible & timely manufacture

●Quality control and regulatory compliance

●Cost effective with product assurance

●Packaging & shipment

●Technical support