MASCARILLA KN95

ESPECIFICACIONES TECNICAS
Codigo Interno FCKN95-04
Nombre: Mascarilla KN95
Marca: Fullcare
El material es polipropileno y poliéster. La capa intermedia es Melt- brown white un
Material: índice de filtración mas del 95%.AJuste nasal.Hipoalergenicas.
Color: Blanco.
MODELO KN95 con barra nasal maleable interior con borde pulido.
Presentación: Caja x 20 unidades.

País de origen China

CERTIFICACION Certificado CE, Estándares de verificacion:EN 149:2001 +A1:2009.
Certificado CMA/CNAS,Estándares de verificacion: GB 2626-2006
CDA de isp

Elemento de protección personal que cubre boca y nariz. Filtra mas del 95% de polvo y partículas finas en el aire. Ayuda a
Función: evitar contagios de virus y bacterias. Tiene una tira de clip de nariz lo que hace que se ajuste, sin raspar y previniendo las
fugas de aire.

Libre de látex y Sí. Estéril: No.

fibra de vidrio
Tamaño: ESTANDAR
Vigencia: 2 años a partir de la fecha de fabricación indicada en el empaque. Fecha vence :05/DICEIMBRE/2023.
Almacenamiento: En lugar fresco y seco. Temperatura 5 a 30°C.
Uso: Producto descartable para un solo uso. No reutilizar.
CARACTERISTICAS DEL PRODUCTO

Suave: Si: X No: No aplica: Resistente: Si: X No: No aplica: Adaptable: Si: X No: No aplica:
Hipoalergénico: Si: X No: No aplica: Respirable: Si: X No: No aplica: Impermeable: Si: No: X

su estructura tiene un nivel de protección KN95/FFP2, filtración de capa por capa para aislar de la contaminación, con espacio transpirable 3D.
La mascarilla posee un adaptador nasal ligero y moldeable situado en el borde superior de forma longitudinal. Tiene dos loop de elásticos a ambos
lados para sujetarlo retro auricular (detrás de la oreja). Modelo muy confortable y ajuste perfecto, a prueba de humedad y no irritante a la piel.
- Filtro bacteriológico mas de 95% hasta 98%. Puede filtrar efectivamente partículas de más de 3 micras de diámetro en el aire.
Primera capa exterior: tela no tejido

Segunda capa: esponja de filtro

Tercera y cuarta capa: Meltblown- filtración PFE>=95%

Quinta capa interior: Tela no tejida amigable con la piel

Certificate – Cертификат – 證明書 – Certificat – 증명서 – ‫شهادة‬ Form QAT_10-M04, version 00, effective since March 6th, 2020

Certificate of Compliance
No. 1P200325Z.WBL0058
Technical Construction File no. EQT-20060318KR-PPE

Certificate’s Wenzhou Bi Liang Bag Making Co., Ltd

Holder: One standard factory building, phase I, Qianku
small and micro business park, Qianku Town,
Cangnan County, Wenzhou City, Zhejiang
Province, CHINA

Certification ECM
Mark: European Type
Conformity Approved

Product: MASK
Model(s): BL-111, BLN-211, BLFE-311, BLPE-511

Verification to: Standard:

EN 149:2001+A1:2009

related to CE Directive(s):
R 2016/425 (Personal Protective Equipment)
Remark: This document has been issued on a voluntary basis and upon request of the manufacturer. It is
our opinion that the technical documentation received from the manufacturer is satisfactory for the
requirements of the ECM Certification Mark. The conformity mark above can be affixed on the products
accordingly to the ECM regulation about its release and its use.
Additional information and clarification about the Marking:

The manufacturer is responsible for the CE Marking process. This document has been
issued on the basis of the regulation on ECM Voluntary Mark for the certification of
products. RG01_ECM rev.3 available at: www.entecerma.it

Issuance date: 25 March 2020

Expiry date: 24 March 2025
Reviewer Approver
Technical expert ECM Service Director
Amanda Payne Luca Bedonni

Ente Certificazione Macchine Srl

Via Ca’ Bella, 243 – Loc. Castello di Serravalle – 40053 Valsamoggia (BO) - ITALY
 +39 051 6705141  +39 051 6705156  info@entecerma.it  www.entecerma.it
 5femnzh

Fiscal Year 2020

CERTIFICATION OF REGISTRATION
This certifies that:
Wenzhou Bi Liang Bag Making Co., Ltd.
One Standard Factory Building, Phase I, Qianku Small and Micro Business
Park, Qianku Town, Cangnan County, Wenzhou City, Zhejiang Province,
325804 , China
has completed the Facility Registration and Device Listing
with the US FDA, through
HUMISS INC.
Owner Operator Number: 10065530
Device Listing#:
Listing Premarket Product Device
Activities Models
Number Submission Code(s) Name(s)

Respirator, Mask, Face Mask, Nonwoven Face Mask,

D381561 Exempt MSH Manufacturer
surgical Medical Disposable Face Mask

HUMISS INC. will confirm that such registration remains effective upon request and presentation of
this certificate until the end of calendar year stated above, unless said registration is terminated after
issuance of this certificate. HUMISS INC. makes no other representations or warranties, nor does
this certificate make any representation or warranties to any person or entity other than the named
certificate holder, for whose sole benefit it is
issued. This certificate does not denote endorsement or approval of the certificate-holder's product(s)
or establishment by the U.S Food and Drug
Administration. HUMISS INC. assumes no liability to any person or entity in connection with
foregoing.

Issued: Mar.29 2020

Certificate No: HU-M-2003290019 Expiration Date:Dec.31, 2020
N° Ref: CD1545048/21

N° CDA 57507/21
Santiago, 11 de febrero de 2021

CERTIFICADO DE DESTINACIÓN ADUANERA

Importador: IMP Y EXP ALJIN CHILE LTDA

RUT Importador: 76497180-9

Dirección/Comuna: LIBERTAD, SANTIAGO

Región de Ingreso: V REGIÓN

Agente Aduana/Código: ADELSDORFER ORELLANA DORA/A01

N° de Documento de Transporte: NGX21V0025R

País Embarque: CHINA

Bodega destino: ALJIN

Dirección/Comuna: LIBERTAD 768, SANTIAGO

El Instituto de Salud Pública de Chile en cumplimiento a lo dispuesto en la ley 18.164/82 del Ministerio de Hacienda, el Código Sanitario y sus
Reglamentos, Decreto Supremo 825/98; ha recibido la solicitud N° CD1545048, el 11 del febrero de 2021, para que se otorgue el Certificado de
Destinación Aduanera a la mercancía detallada en el anexo foliado adjunto, que forma parte del presente documento, ingresada por la Aduana SAN
ANTONIO, para ser presentado ante el Servicio Nacional de Aduanas.

De acuerdo a lo declarado por IMP Y EXP ALJIN CHILE LTDA se certifica que las referidas mercancías serán trasladadas a la bodega de destino
señalada precedentemente.

Por delegación del Director del Instituto de Salud Pública de Chile.

RESPONSABLE FIRMA
CARGO RESPONSABLE
DEPARTAMENTO AGENCIA NACIONAL DE MEDICAMENTOS
INSTITUTO DE SALUD PÚBLICA DE CHILE
N° Ref: CD1545048/21

N° CDA 57507/21
Santiago, 11 de febrero de 2021

CERTIFICADO DE DESTINACIÓN ADUANERA

"ANEXO DE PROVEEDOR Y PRODUCTOS"

Proveedor País Factura/Año

WENLING ANDISI TRADE CO, LTD CHINA ADS2101

Sección V. Dispositivos Médicos Sin Registro Sanitario

1 - MASCARILLAS
Nombre DM ISP: MASCARILLAS

Nombre Productor: WENLING ANDISI TRADE CO, LTD

País Productor: CHINA

País Procedente: CHINA

Cantidad: 685000

Unidad: UNIDADES

Lote(s): FCKN95-04
 检 验 报 告
TEST REPORT

Scan is following us Scan checks for authenticity

*W202048837E*

浙江省轻工业品质量检验研究院
Zhejiang Light Industrial Products Inspection and Research Institute

国家纺织服装产品质量监督检验中心（浙江）
National Textiles and Garment Quality Supervision Inspection Center(Zhejiang)
 Zhejiang Light Industrial Products Inspection and Research Institute
National Textiles and Garment Quality Supervision Inspection Center(Zhejiang)

Test report
Number:W202048837E page1/3

One standard factory building,

phase I, Qianku luggage small and
Name of Customer Wenzhou Biliang Bag Making Co., Ltd Address micro entrepreneurship Park, Qianku
Town, Cangnan County, Wenzhou City,
Zhejiang Province

Manufacturer --- Address ---

Name of sample：Textile mask

Characteristics of sample：WHITE
Trademark of sample：---
Sample Specification/model：---
Level：KN95
information
Category of safety specification：GB 18401-2010(B)
Art. No.：---
------------------------------------------------

Above-mentioned information by Customer-supplied

The sent way of

Courier Sample quantity 50 pieces
sample
Receiving Date of
2020/12/02 Test Category Entrusted inspection
Sample

Date of Testing 2020-12-02~2020-12-07

RatingRequirements GB 18401-2010(B) GB2626-2006

Test Summary：

See the attached page for the results.

[签章]
Test Seal

Date of Approval：2020-12-07

Remarks

Approved by:
 Test report
Number:W202048837E page2/3

STANDARD
ITEM RESULT RATING
(KN95)
1. FILTER EFFICIENCY(NaCl PARTICLE)
(GB 2626-2006 6.3)(%)
Before pretreatment：99.4
- ≥95.0 PASS
After pretreatment：99.2
2. RESPIRATORY RESISTANCE
(GB 2626-2006 6.5 & 6.6)(Pa)
Before pretreatment：
162,178
-INSPIRATORY RESISTANCE ≤350 PASS
After pretreatment：
149,151
Before pretreatment：
133,147
-EXPIRATORY RESISTANCE ≤250 PASS
After pretreatment：
135,138
3. HEADBAND
(GB 2626-2006 6.11)
10N,hold on10s, No breakage or slippage
- PASS
No breakage or slippage were observed
4. APPEARANCE
(GB 2626-2006 6.1 & 6.2)
The appearance quality of
Meet the requirements of
- 2 masks conforms to the PASS
GB 2626-2006 standard
standard
5.VISUAL FIELD BELOW MASK
(GB 2890-2009)(°)

- ≥60 77 PASS

6. . FORMALDEHYDE
(GB 2626-2006、GB/T 2912.1-2009)(mg/kg)

- ≤75 NOT DETECTED PASS

Remark：1.FORMALDEHYDE:Method Detection Limit:20mg/kg

 Test report
Number:W202048837E page3/3

Picture(s) of sample

—End of report—
 DECLARATION
1. Our organization guarantees impartiality, independence and honesty of inspection, and is responsible for the results of
inspection, keeping the samples supplied by the entrusting party confidential and at the same time protecting the ownership of
the samples supplied.
2. The test report will be deemed invalid without signatures of the inspector/reviewer and authorized personnel, and the red
special inspection stamp of our organization.
3. The test report will be invalid if it is altered. Copies of the report are invalid without the red special inspection stamp of our
organization.
4. The test results shown in this report are applicable only to the samples provided by customers.
5. All the pages of the report are integral parts of the report. Our organization will not be responsible for any
misunderstanding or other results caused by using separate page(s) of the report.
6. If there is any dissent of the report, the entrusting party shall notify our organization timely. For the mandatory inspection
given by governmental administration departments, and dissent about the sample being tested or test results on the report
should be dealt with in accordance with national regulations.

浙江省轻工业品质量检验研究院及附设的检验中心
The Affiliated Inspection Centers
浙江省轻工业品质量检验研究院 联系电话：0571-85122669
Zhejiang Light IndustrialProductsInspectionandResearchInstitute Telephone：0571-85122669
国家纺织服装产品质量监督检验中心（浙江）
National Textiles and Garment Quality Supervision Inspection Center(Zhejiang) E-Mail：1137907994@qq.com
地址：浙江省杭州市江干区下沙路 300 号 6 号楼
Address：Building No.6, 300 XiaSha Road, Hangzhou, Zhejiang

国家家具产品质量监督检验中心（浙江） 联系电话：0571-89009556
National Center for Quality Supervision Inspection of Furniture(Zhejiang) Telephone：0571-89009556
浙江省室内安全及家具产品质量检验中心
Zhejiang Center of Quality Test for Indoor Safety and Furniture Products E-Mail：2047699564@qq.com
地址：浙江省杭州市余杭区良渚街道经一路 1 号良渚大学科技园 4 号楼
Address：Building 4 LiangZhu University Science and Technology Park, No.1,
JingYi Rd, Yuhang District, Hangzhou, Zhejiang

浙江省轻工及五金产品质量检验中心 联系电话：0571-89001107
Zhejiang Center of Quality Test for Light Industry and Hardware Products Telephone：0571-89001107
浙江省体育用品质量检验中心
Zhejiang Center of Quality Test for Sports Products E-Mail：wujtest@126.com
地址：浙江省杭州市西湖区天目山路 222 号 3 号楼
浙江省杭州市余杭区良渚街道经一路 1 号良渚大学科技园 3 号楼
Address：No. 222 Tianmushan Rd., Hangzhou, Zhejiang
Building 3 LiangZhu University Science and Technology Park, No.1,
JingYi Rd., Hangzhou, Zhejiang

国家锁具产品质量监督检验中心（浙江） 联系电话：0571-85027738
National Center for Quality Supervision Inspection of Lock(Zhejiang) Telephone：0571-85027738
浙江省锁具产品质量检验中心
Zhejiang Center of Quality Test for Lock Products E-Mail：Locktest@126.com
地址：浙江省杭州市塘苗路 24 号
Address：No. 24 Tangmiao Rd., Hangzhou, Zhejiang

网上业务受理/报告查询：http://www.zjttj.cn 投诉电话：0571-85023552
Online Business-Reception/Report Inquires: http:// www.zjttj.cn Complaint Tel：0571-85023552