[Case Study] The Filing of Medical Isolation Gown

[Case Analysis] The Filing of Medical Isolation Gown

As a medical protective device, the medical isolation gown has played a significant role in the prevention and control of the epidemic, and it is also an emergency supplies. The medical device service team of CIRS Group, based on the national epidemic prevention and control requirements and corporate needs, urgently assisted a number of enterprises to file their medical isolation gowns. In conjunction with the emergency approval policy during the epidemic prevention and control, we now share the filing requirements and processes of medical isolation gown as follows: 

1. Overview of medical isolation gown products

-    Product name: Isolation gown

-    Structural composition: Isolation gowns are usually made of non-woven fabrics through cutting and sewing. Non-sterile, single-use.

-    Working principle: Use the barrier effect of clothing to protect medical staff from contamination by blood, body fluids and other infectious substances, or to protect patients from infection.

-    Intended use: For general isolation in medical institutions' clinics, wards, test rooms, etc.

-    Target user: Suitable for people who need protection in various environments.

-    Intended use environment: medical institution clinic, ward, laboratory, etc.

2. Medical Isolation Gown Classification Information

Subdirectory

First-level subdirectory

Second-level subdirectory

Product description

Intended use

Example

Class

14

Infusion, nursing and protective equipment

14

Medical staff protective equipment

03

Isolation gown/cap

Usually made of non-woven fabrics through cutting and sewing. Non-sterile, single-use.

For general isolation in medical institutions' clinics, wards, test rooms, etc.

Isolation gownMedical cap

Medical isolation gowns are managed in accordance with the Class I medical devices, and the medical device filing process needs to be completed as required. 

3. Clinical trial requirements for medical isolation gowns

 Not required: Class I medical devices do not require clinical trials 

4. Technical requirements for medical isolation gown

4.1 Appearance

1) The gown should be dry, clean and free of mildew spots, and no defects such as adhesion, cracks, holes, etc. are allowed on the surface.

2) The connection part of the gown can be processed by stitching, bonding or heat sealing. The needle eye of the needle seam should be sealed. The needle pitch should be 8 ~ 14 stitches every 3cm. Adhesive or heat-sealed parts should be flat and sealed without air bubbles.

3)The zipper of protective clothing equipped with zipper should not leak, the zipper slider should be able to lock itself

4.2 Structure

1)The structure of the isolation gown should be reasonable, easy to put on and take off, and tightly bonded.

2) Adopt elastic cuffs at the cuffs and ankles; And adopt elastic closure, drawstring closure, or buckle at the neck and waist。

4.3 Model specifications

Medical isolation gown models are generally divided into 160, 165, 170, 175, 180, and 185. See the specifications in Table 1 and Table 2. (Refer to GB 19082-2009 Technical Requirements for Medical Disposable Protective Clothing)

Table 1 One-piece type specifications

Unit: cm

Model

Height

Chest

Sleeve Length

Cuff

Leg Opening

160

165

120

84

18

24

165

169

125

86

18

24

170

173

130

90

18

24

175

178

135

93

18

24

180

181

140

96

18

24

185

188

145

99

18

24

Deviation

±2

±2

±2

±2

±2

Table 2 Split type specifications

Unit: cm

Model

Clothes Length

Chest

Outside Length

Waistline

160

76

120

105

100~105

165

78

125

108

105~110

170

80

130

111

110~115

175

82

135

114

115~120

180

84

140

117

120~125

185

86

145

120

125~130

Deviation

±2

±2

±2

±2

4.4 Moisture resistance

The spray rating on the outer side is not lower than level 3.

4.5 Breaking strength

The breaking strength of the material of the critical part of the gown shall not be less than 45N.

4.6 Elongation at break

The elongation at break of the material of the critical part of the gown shall not be less than 15%.

4.7 Microorganisms

Meet the requirements of microbial indicators in GB 15979-2002, see Table 3

Table 3 Microbiological indicators

Total bacterial colonies CFU/g

Coliform

Pseudomonas aeruginosa

Staphylococcus aureus

Hemolytic streptococcus

Total fungal colonies CFU/g

≤200

Not detectable

Not detectable

Not detectable

Not detectable

≤100

 

5. Technical standards applicable to medical isolation clothing

GB/T 191-2008

Packaging storage and transportation icon sign

GB 19082-2009

Technical requirements for medical disposable protective clothing

GB/T 3923.1-2013

Textiles-Tensile properties of fabrics-Part 1 Determination of breaking strength and elongation at break (strip method)

GB/T 3923.2-2013

Textiles-Tensile properties of fabrics-Part 2 Determination of breaking strength (grabbing method)

GB/T 4745-2012

Testing and Evaluation of Waterproofing Performance of Textiles

GB 15979-2002

Hygienic standard for single-use sanitary products

 

6. Recording duration of medical isolation gown

As a Class I medical device, the medical isolation gown goes through the filing system, and submits filing materials on the spot. After passing the on-site review, a filing voucher is issued on the spot.

The filing voucher of medical isolation gown contains two parts: the Class I medical device filing voucher and the Class I medical device filing information form.



Contact Us
CIRS China

Mr. Harold Xie (Head office)
Tel: +86-571 8720 6559 | Fax: +86-571 87206533
Email: md@cirs-group.com
Mr. Edwin Wen (Beijing office)
Tel: +86-10 63984062 | Fax: +86-10 63984032
Email: md@cirs-group.com

CIRS Europe

Bryan Zhou
Tel:  +353 (1)477 3710

Email: md@cirs-group.com

CIRS Korea
Mr. Junho Lee 
Tel: +82 2 6347 8801 
Email: md@cirs-group.com