본문으로 바로가기
Product Thumnail Image
Product Thumnail Image
Product Thumnail Image
Product Thumnail Image
Product Thumnail Image
Product Thumnail Image

KF94 Respiratory Face Mask

By Makelean Every Guard KF94 Mask

Negotiable | Min. Order

Description
[ Product Information_Main Features ] This is "Korean MFDS(Ministry of Food and Drug Safety) Accredited-KF94 Face Mask", basically. Followings are main features of our KF94 Respiratory Face Mask. ▶ CE DOC + European Standardl(EN) QualificationCurrently, the most compatible standard is EN 14683(Type IIR); MDD Performance test & ISO 10993-3 10; Bio Compatibility test. This KF94 series mask already has been qualified with the MDD performance test criterias as of Oct. 23rd 2020 and waiting for the result of another test, Bio-compatibility (ISO 10993). We assure that these 2 qualification will be equipped within Dec. 2020 and be able to declare its conformity in MDD. ▶ FDA Class II Lev.01 test, ASTM F2100 + FDA ListingSimulteneously, this product is being under testing in accordance with FDA Class II Lev.01., ASTM F2100 criteria and will receive its result within 1 month from today, Nov. 02nd 2020. Therefore, it will be able to have all standard qualification in Medical Devices required within this Dec. 2020. Written by Matt HM Jeong, International Business Department Manager Nov. 02nd 2020.
Place of Origin
South Korea
Payment Terms
T/T
TKPAY Sample
Samples INFO

Negotiable | (Min. Order)

Payment
  • visa
  • master
  • jcb
  • unionPay
  • 1 MAKELEAN CO.,LTD.

    Supplier Activity

    Country South Korea South Korea

    KITA

    Send Message
    PRODUCT DESCRIPTION
    COMPANY INFORMATION
    Product Information


    [ Product Information_Main Features ]

     

     

    This is "Korean MFDS(Ministry of Food and Drug Safety) Accredited-KF94 Face Mask", basically. Followings are main features of our KF94 Respiratory Face Mask.

     

     

     

    CE DOC + European Standardl(EN) Qualification

    Currently, the most compatible standard is EN 14683(Type IIR);  MDD Performance test & ISO 10993-3 10; Bio Compatibility test.

    This KF94 series mask already has been qualified with the MDD performance test criterias as of Oct. 23rd 2020 and waiting for the result of another test, Bio-compatibility (ISO 10993). We assure that these 2 qualification will be equipped within Dec. 2020 and be able to declare its conformity in MDD.

     

    FDA Class II Lev.01 test, ASTM F2100 + FDA Listing

    Simulteneously, this product is being under testing in accordance with FDA Class II Lev.01., ASTM F2100 criteria and will receive its result within 1 month from today, Nov. 02nd 2020.

     

    Therefore, it will be able to have all standard qualification in Medical Devices required within this Dec. 2020.

     

     

    Written by 

    Matt HM Jeong, International Business Department Manager

     

    Nov. 02nd 2020.

     

     

    Image
    • 495 x 498 JPG

    • 495x902 JPG

    • 498 x 498 JPG

    • 500x500

    • 20201117_102508

    Feature

     

    Spec

     

    [ Supplement Information_ Fitting Type, Packing and MOQ, etc. ]

     

     

     

    1. Item(i.e. Product Name / Serial No. )

      1.1 KF94 Respiratory Face Mask Series / Makelean Every Guard-KF94-MK-ORD-W-01  (White)

      1.2 KF94 Respiratory Face Mask Series / Makelean Every Guard-KF94-MK-ORD-B-01  (Black)

      1.3 KF94 Respiratory Face Mask Series / Makelean Every Guard-KF94-MK-ORD-W-02  (White)

      1.4 KF94 Respiratory Face Mask Series / Makelean Every Guard-KF94-MK-ORD-B-02  (Black)

     

    2. Color:  Black, White (2 colors)

     

    3. Fitting(Wearing) Type

      3.1 Ear Strap + Side Strap

      3.2 Ear Strap only.

     

    4. Packing:  Pouch < Outer Carton < International Standard Palletizing for the shipment

     

    5. MOQ(Minimum Order Quantity)

      5.1 1 ea/pouch, Ear Strap = approx. 280,000 pcs = 40’ Dry container max stuffing

      5.2 5 ea/pouch, Ear Strap = approx.. 400,000 pcs = 40’ Dry container max stuffing

      5.3 1 ea/pouch, Ear Strap + Side Strap = approx.. 240,000 pcs = 40’ Dry container max stuffing

      5.4 5 ea/pouch, Ear Strap + Side Strap = approx.. 360,000 pcs  = 40’ Dry container max stuffing

     

    6. Daily Capacity(8 hrs a day)

      6.1 Ear Strap + Side Strap: 10,000 pcs /  day

      6.2 Ear Strap only: 100,000 pcs / day

     

    7. Payment

      7.1 60% down-payment before production

      7.2 40% balance before shipment

     

    8. FOB Cost(Price, US$):  US$ 0.58 /pcs  (in purchasinsg MOQ)

     

    9. Lead Time: be noted very soon due to the current existing orders

     

    10. Factory Location:  Namyangju-si, Gyeonggido, Korea

     

    11. Port of Departure: Busan, Korea

     

    Company
    MAKELEAN CO.,LTD.

    MAKELEAN CO.,LTD.

    Country South Korea South Korea

    Supplier Activity

    President
    Lee Chang Bok
    Address
    17-27, Parya-ro, Jinjeop-eup, Namyangju-si, Gyeonggi-do, Korea
    Product Category
    Medical Face Mask
    Year Established
    2016
    No. of Total Employees
    1-50
    Company introduction

    Dear Sir or Madam,

     

     

    In accordance with THE OCCUPATIONAL SAFETY AND HEALTH ACT, enforced byKOSHA(Korean Occupational Safety & Health Agency), an authorized Entity ofKorea Ministry of Employment and Labor,

     

    Makelean’s Top Priority in all business activities is to be with Respectto human beings. We, Makelean Co., Ltd., do plan and check all activities to bemonitored, implemented and enhance of HSE management system. We actively seekand are used to enhancing continuous improvement in our HSE practices. TheHealth, Safety of all employees are of Prime Importance to Makelean Co., Ltd.We carry out the following activities in order to;

     

    (To) Maintain practically the highest achievable standards of safety,occupational health and environmental protection. (To) Improve continuouslyaccident and incident prevention by pre-planning, implementation of safetyprocedures. (To) Create the necessary safety awareness amongst all staffthrough training and supervision. (To) Protect the environment from accidentalcontamination and damage. (To) Minimize the environmental impact of ouroperations by conserving natural resources, eliminating waste, reusing andrecycling materials and responsibility managing energy use. With implementingthe statement above, Makelean Co., Ltd. will step forward to accomplish ourvision, continuously.

     

    Thank you. Sincerely, Mr. Chang Bok Lee, President

     

     

    Factory Information
    Makelean Manufacture Site #2, Makelean Manufacture Site #1

    Other Products from This Supplier

    Other Products viewed with This Product