Product name: Multifunctional medical elastic sleeve (elastic bandage)

Registered trademark: Zilimei

Product category: Class I medical device products

Production record: Minpu Food and Drug Supervision Equipment Production No. 20220001

Product filing: Minpu Machinery Equipment 20220005

Executive standard: FZ/T 73019.1-2017

Safety category: Class A, GB31701-2015 (direct contact with skin, can be used by infants and young children)

Product technical requirements

1. Performance indicators

1.1 Appearance

1.1.1 The product shall be free from defects such as distortion, breakage, burrs, burrs, uneven stitches, etc.

1.1.2 The color of the product is flesh color, the black model is black, and there are no defects such as variegated color and uneven dyeing.

1.2 Dimensions

The size of the product should meet the requirements of the standard value in Annex 1.

1.3 Mass per unit area

The product weight per square meter is 270g±10g.

1.4 Elastic recovery rate

The elastic recovery rate of the product is ≥90%.

1.5 marble burst strength

The breaking strength of the product marble is ≥400N.

1.6 Lycra spandex content

The Lycra spandex content of the product is 44%±%2.

2. Inspection method

2.1 Appearance

Visual observation and hand-held touch should meet the requirements of 2.1.

2.2 Dimensions

Measure with a general measuring tool, which should meet the requirements of 2.2.

2.3 Mass per unit area

According to the test method specified in 5.5 of YY/T 0507-2009, it should meet the requirements of 2.3.

2.4 Elastic recovery rate

According to the test method specified in 5.8 of YY/T 0507-2009, it should meet the requirements of 2.4.

2.5 marble bursting strength

According to the test method specified in GB/T 19976-2005, the diameter of the steel ball is 38±0.02mm, which should meet the requirements of 2.5.

2.6 Lycra spandex content

According to the test method specified in FZ/T 01095-2002, it should meet the requirements of 2.6.

Brand authorization: Hong Kong Zilimei (International) Medical Technology Group

Office Address: Shop 3D, G/F, Chinachem Prince Building, 93-99 Mong Kok Road, Kowloon, Hong Kong

Fujian production area: Putian Zilimei Network Technology Co., Ltd.

Production Address: 3rd Floor, No. 623, Huahui Road, Huating Town, Chengxiang District, Putian City, Fujian Province

Production record: Minpu Food and Drug Supervision Equipment Production No. 20220001

Henan production area: Henan Yalini Medical Technology Co., Ltd.

Production address: No. 1104-6, Block B, Olive City Urban Plaza, Lianyun Road, Erqi District, Zhengzhou City, Henan Province

Production record: Yuzheng Food and Drug Administration Production No. 20200077

Guangdong production area: Guangzhou Zilimei Biotechnology Co., Ltd.

Production address: No. 319, Building C4, Square Logistics Park, No. 2, Milong Longshang Road, Taihe Town, Baiyun District, Guangzhou

Production record: Yuesui Food and Drug Administration Production No. 20180010