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Type IIR- 3 Layer Disposable Elastic on Ear Surgical Mask

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The raw material of our mask, which we offer in our product range as Type IIR, is 3-layer nonwoven fabric and meltblown fabric is used in the middle layer.

Bacteria filtration efficiency: 99.3%

Passes Splash Resistance Test

TD. KK. 01 User Manual of Surgical Mask

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Description

The raw material of our mask, which we offer in our product range as Type IIR, is 3-layer nonwoven fabric and meltblown fabric is used in the middle layer.

Our masks with 99.3% Bacteria Filtration Efficiency also pass the splash resistance tests.

It is produced in full automatic ultrasonic mask machines with ultrasonic laser cutting technique.

It has been designed in 2 different models to offer different options to the user.

In addition to our model with wire on the nose and flexible back of the ear, our long elastic comfortable model with passage behind the head is also presented to our users.

It can be adjusted to the face with a soft and flexible nose wire.

It filters dust, small particles, mist and other pollutants with its high filtering ability.

With its soft and delicate texture, antiallergic and breathable structure, it offers comfortable use and ease of breathing for our users.

If desired, it can be used with protective glasses. Test approvals of EN 14683, EN 10993-1, EN 10993-5, EN 10993-10, EN ISO 11737-1 are available.

  • Bacteria Filtration Efficiency: EN 14683: 2019 AC: 2019 (ANNEX-B / Table 1)
  • Microbial Cleaning: EN ISO 11737-1: 2018
  • Breathability / Pressure Difference: EN 14683: 2019 AC: 2019 ANNEX-C / Table 1)
  • Biocompatibility Test (Sentitation, Irritation, Cytotoxicity): TS EN ISO 10993-5: 2009 TS EN ISO 10993-1: 2018, TS EN ISO 10993-12: 2012
  • Splash Resistance Pressure (Splashing Test): EN 14683: 2019

In our production site authorized by the Turkish Ministry of Health Medical Device Sales Authority,
It is produced according to the requirements of ISO 13485 quality management system.

Approved Documents:
Test reports,
EC declaration,
ISO 13485 standard,
Technical File Review Report for Szutest Class 1 Products,

Click for Instructions for Use : Type IIR- 3 Layer Disposable Surgical Mask Instructions for Use

Additional information

Product Type

Type IIR- 3 Layer Disposable Elastic on Ear Surgical Mask

Fabric Structure

Non-woven

Fabric Weight

20 gsm Spunbond PP (used for 3rd layer), 25 gsm Meltblown PP (used for 2nd layer), 30 gsm Spunbond PP (used for 1st layer)

Fabric Width

1st layer fabric width 19,5 cm, 2nd layer fabric width 17,5 cm, 3rd layer fabric width 17,5 cm

Packaging Options

10 Piece Masks, 100 Pieces Mask, 5 Piece Masks, 50 Piece Masks, Single Mask