AMPri Style Black Nitrile Gloves, black, powder-free, 100 pieces, size XXL, 01181-XXL

Gloves used in laboratories and kitchens need evidence for both areas: chemical protection on the one hand, food contact on the other. Both are documented for the AMPri Style Black. According to the data sheet, it is also classified as a Class I medical device and designed as personal protective equipment of Category III with chemical protection according to EN ISO 374-1 Type B. The glove is black, powder-free and made of nitrile. It is available in sizes XS to XXL, and one pack contains 100 pieces.

Nitrile gloves as a Class I medical device

AMPri lists the Style Black as a nitrile examination glove. It is classified as Class I according to Annex VIII of Regulation (EU) 2017/745 and, according to the data sheet, meets standards EN 455-1 to EN 455-4. In the water leak test according to EN 455-1, the AQL is below 1.5 (sampling inspection according to ISO 2859-1, general inspection level I). The gloves are non-sterile and intended for single use.

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

Type B means that a glove passes at least three test chemicals of the standard at permeation level 2 or better. The data sheet lists three substances. Sodium hydroxide 40 % (code letter K) achieves level 6, which corresponds to a breakthrough time of more than 480 minutes. Hydrogen peroxide 30 % (P) achieves level 2 (more than 30 minutes), formaldehyde 37 % (T) achieves level 5 (more than 240 minutes). According to EN ISO 374-5, the glove is also impermeable to bacteria, fungi and viruses (testing according to ISO 16604, procedure B).

The values come from laboratory tests on samples taken from the palm. According to the manufacturer, the actual duration of protection can differ significantly depending on temperature, abrasion and stretching, and likewise for mixtures. A separate risk assessment remains necessary for the specific workplace.

Food contact with declaration of conformity

For the Style Black, AMPri issued a declaration of conformity for materials in contact with food on 28 October 2025. It refers to Regulation (EC) No 1935/2004, Regulation (EU) No 10/2011, the LFGB and BfR Recommendation XXI. According to the declaration, the gloves may be in direct contact with all types of food for a short time; the declaration states no restrictions. The overall migration is below 3 mg/dm², the limit is 10 mg/dm².

Thickness, surface and fit

The thickness is 0.06 mm at the cuff, 0.07 mm on the palm and 0.10 mm at the fingertips. The fingertips are textured, and the inside of the glove is chlorinated. The fit is ambidextrous, and the length is at least 240 mm for all sizes.

Choosing the right size

The manufacturer assigns a numerical glove size to each size. XXL corresponds to glove sizes 10 to 11 and has a width of 125 mm (± 10 mm). For comparison, the black gloves Meditrade Nitril Black (S to XL) and Unigloves Black Pearl (XS to XL) end one size earlier.

Information on allergies, storage and disposal

The data sheet points out that the glove contains dithiocarbamates, which can trigger allergic reactions. The gloves are stored in their original packaging, cool and dry, protected from sunlight and not near sources of ozone such as laser printers or photocopiers. The manufacturer does not specify a general shelf life; the expiry date is printed on the packaging.

Before use, the gloves are to be checked for holes and damage. After contact with chemicals, disposal is governed by the regulations for the chemical concerned. Unused gloves can be disposed of with household waste. Disinfection of the gloves is not provided for.

Typical applications

• Laboratory: preparing solutions, preparing samples, handling alkalis and peroxides at the tested concentrations
• Kitchen and food processing: portioning and serving food
• Medical practice and care: examinations with a glove classified as a Class I medical device
• Cleaning: working with sodium hydroxide, hydrogen peroxide or formaldehyde at the tested concentrations
• Studios and practices where a black glove is desired

Frequently asked questions about the Style Black

Is the Style Black a medical device?
Yes, according to the data sheet, it is a Class I medical device according to Regulation (EU) 2017/745. It meets EN 455-1 to EN 455-4.

May the glove come into contact with all types of food?
According to the manufacturer’s declaration of conformity of 28 October 2025, short-term direct contact with all types of food is possible. The declaration states no restrictions.

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

Does the glove contain substances that can trigger allergies?
The data sheet refers to dithiocarbamates, which can trigger allergic reactions. It names nitrile as the material.

How many gloves does a pack contain?
100 pieces, i.e. 50 pairs. The manufacturer packs ten packs into one outer carton.

What is the shelf life of the gloves?
The manufacturer does not specify a general expiry period; it depends on the conditions of use. The expiry date is printed on the packaging.

Technical details

Scope of delivery

• 1 pack with 100 pieces of AMPri Style Black nitrile gloves (size according to variant selection)

Regulatory information

The Style Black is a Class I medical device according to Annex VIII of Regulation (EU) 2017/745 with the standards EN 455-1 to EN 455-4. At the same time, it is personal protective equipment of Category III according to Regulation (EU) 2016/425 with the standards EN ISO 374-1 (Type B), EN ISO 374-5 and EN ISO 21420. The glove is CE-marked.

For food contact, a declaration of conformity of the manufacturer dated 28 October 2025 is available (Regulation (EC) No 1935/2004, Regulation (EU) No 10/2011, LFGB, BfR Recommendation XXI). The manufacturer is AMPri Handelsgesellschaft mbH, Benzstraße 16, 21423 Winsen (Luhe), SRN DE-MF-000007622.

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.