Tempo Healthcare Nitrile Examination Gloves, blue, powder-free, 100 pieces, size L

Medical practices, laboratories and cleaning services have different requirements for disposable gloves. The blue Tempo Healthcare nitrile examination gloves carry information on the box about medical use and chemical protection: According to the print, they are classified as a Class I medical device according to Regulation (EU) 2017/745 and designed as personal protective equipment of Category III with chemical protection according to EN ISO 374-1 Type B. The box bears the om brand, and distribution in Germany is handled by Tempo Healthcare GmbH. The glove is blue, powder-free, non-sterile and intended for single use. Sizes S and L are available, and one box contains 100 pieces.

Class I examination glove with EN 455

The box carries a reference to the Medical Devices Regulation (EU) 2017/745, Class I, together with the symbol for medical devices. The four parts of EN 455 are also named. For medical single-use gloves, they cover leak-tightness, physical properties, biological evaluation and the determination of shelf life. The box gives an AQL (acceptable quality limit) of 1.5. The glove is therefore intended for examinations where a medical device is required.

Chemical protection according to EN ISO 374-1 Type B (KPT)

Type B requires that at least three test chemicals of the standard are passed with permeation level 2 or better. The box names three substances. Sodium hydroxide 40 % (code letter K) achieves level 6, which corresponds to a breakthrough time of more than 480 minutes. Formaldehyde 37 % (T) achieves level 5 (more than 240 minutes), hydrogen peroxide 30 % (P) level 2 (more than 30 minutes). The mean degradation according to EN 374-4 describes how much the glove material changes after contact. It is -38.4 % for K, 46.6 % for T and 17.6 % for P.

According to EN ISO 374-5, the glove is tested against viruses (marking VIRUS). Resistance to bacteria and fungi is stated as passed. For the PPE, the box names the EU type examination and the ongoing surveillance by the notified body SATRA Technology Europe Ltd (identification number 2777). The values apply to the stated substances in the tested concentrations. For other chemicals and for mixtures, a separate assessment of the workplace is necessary.

Food contact with a restriction

The box shows the symbol for food contact. The accompanying text names suitability for handling food, except acidic food, and refers to a test over 2 hours at 40 °C. This is a statement on the packaging. Anyone who has to document food contact in their operation should request the evidence from the manufacturer.

Material, fit and allergy information

The glove consists of 100 % synthetic nitrile polymer and contains no natural latex. It can be worn on either hand and is at least 240 mm long in all sizes. The box points out that components can trigger allergic reactions in some users.

Finding the right size

The size depends on the hand width. For each size, the manufacturer states the hand width and a numerical glove size; the tolerance is ± 3 mm in each case.

Storage and use

The gloves are stored cool and dry at -10 °C to 40 °C and protected from sunlight and fluorescent light. Damaged gloves are not used. Each glove is intended for single use only.

Typical applications

• Medical practice and care: examinations with a glove classified as a Class I medical device
• Laboratory: preparing samples, preparing solutions, handling sodium hydroxide, hydrogen peroxide and formaldehyde at the tested concentrations
• Cleaning: working with alkalis and peroxides at the tested concentrations
• Kitchen and food processing: handling food, except acidic food, according to the statement on the box
• Work areas where the glove colour blue serves as identification

Frequently asked questions about the Tempo Healthcare examination gloves

Is the glove a medical device?
Yes, the box names the classification as a Class I medical device according to Regulation (EU) 2017/745 and the standards EN 455 Parts 1 to 4.

What do Type B and KPT mean?
Type B stands for at least three passed test chemicals according to EN ISO 374-1. K, P and T are the code letters for sodium hydroxide 40 %, hydrogen peroxide 30 % and formaldehyde 37 %.

May the gloves come into contact with food?
The box names suitability for handling food, except acidic food. It is a manufacturer’s statement on the packaging.

Do the gloves contain natural latex?
No, they consist of 100 % synthetic nitrile polymer. Allergic reactions to components are nevertheless possible in some users.

Which size do I need?
The hand width in millimetres decides, see the table above. A hand with a width of 100 mm lies between M (94 mm) and L (105 mm).

How many gloves does a box contain?
100 pieces, i.e. 50 pairs.

Technical details

Scope of delivery

• 1 box with 100 pieces of Tempo Healthcare nitrile examination gloves, blue (size according to variant selection)

Regulatory information

The glove bears the CE mark with the identification number 2777. According to the print, it is a Class I medical device according to Regulation (EU) 2017/745 and personal protective equipment of Category III according to Regulation (EU) 2016/425. The standards named are EN 455 Parts 1 to 4, EN ISO 374-1:2016 (Type B), EN ISO 374-5:2016 and EN 420:2003+A1:2009. The notified body for the PPE is SATRA Technology Europe Ltd, Bracetown Business Park, Clonee, D15YN2P, Ireland. The statement on food contact is a manufacturer’s statement.

The manufacturer is Blue Sail Medical Co., Ltd., No.21 Qingtian Rd, Qilu Chemical Industrial Park, Zibo, Shandong Province, 255414 P.R. China.

The EU authorised representative is Lotus NL B.V., Koningin Julianaplein 10, le Verd, 2595AA The Hague, Netherlands, email peter@lotusnl.com.

Distribution in Germany: Tempo Healthcare GmbH, Kunibertstraße 6, 59457 Werl, telephone +49 2922 927539-0, email info@tempohealthcare.de.

Individual requirements & procurement service

Do you need a different size, a different glove material or larger purchase quantities? Our procurement service helps with the selection. You can find further gloves in the Nitrile Gloves category. Another blue nitrile examination glove is the Unigloves Blue Pearl (XS to XL).