PPE Testing in Pakistan: EU 2016/425 Compliance

The category decides who signs off, and it follows the highest risk

Article 18 and Annex I sort PPE into three categories, and a product that protects against several risks takes the category of the highest one (European Commission). Article 19 then fixes the conformity route for each category.

The Annex I list for Category III is exhaustive, and so is the list for Category I. That leaves Category II as the default: a protective product that is neither minimal risk nor on the serious list needs a Notified Body.

A worked classification: one Sialkot glove range lands in four places

The Commission's PPE Regulation Guidelines, 5th edition, Oct 2025 end with a categorisation guide that places common products. A factory making sports, work and motorcycle gloves can span every outcome:

The same guide places protective footwear in Category II (entry 8.1) unless it insulates against dangerous voltages or is built for heat equivalent to 100 °C air, which makes it Category III. High visibility clothing and accessories are Category II (15.1 and 15.2); reflective keyrings and backpacks are not PPE (15.4). All respiratory protective equipment against aerosols or gases is Category III (7.1).

The label a buyer uses does not decide the category. A gardening glove that the catalogue also sells for "light industrial handling" claims protection against mechanical risk beyond superficial pricks, and that claim can move it into Category II.

A type-examination certificate lasts five years at most

For Category II and III, the Notified Body examines the technical documentation and a production-representative specimen, then issues an EU type-examination certificate. Annex V of the regulation sets the rules that follow it:

For Category II and III, the EU declaration of conformity must name the Notified Body, give its identification number and quote the certificate number. For Category III it also names the body that assesses production (Commission guidelines).

Under Article 16 the CE marking goes on the product visibly, legibly and indelibly before it reaches the market, or on the packaging and accompanying documents when the product cannot carry it.

Each product family has a harmonised standard that sets its tests

A harmonised standard gives a presumption of conformity with the essential health and safety requirements it covers (European Commission). The test report against that standard is the evidence the Notified Body reviews.

Sources: ISO 21420, SATRA on EN 388, SATRA on EN 407, ISO 13688, ISO 20471, SATRA on EN 149, EN 455, and Tti Labs PPE testing for the footwear, welders' and motorcycle standards.

How to read the EN 388 code on a glove

An EN 388 glove carries a hammer pictogram with up to six characters. The first four digits are abrasion, coup cut, tear and puncture. The fifth character is a letter for the TDM straight-blade cut test. A final P means the glove passed the impact test, run to clause 6.9 of EN 13594:2015 (SATRA).

Worked example: a glove marked 4X43C P resists at least 8,000 abrasion cycles, has no coup result (X means the test was not performed), resists at least 75 N in tear and 100 N in puncture, needs at least 10 N to cut through in the TDM test, and passed the impact test. A 0 in the first four positions means the glove did not reach level 1.

The two cut tests do not correlate. When the coup blade blunts on the material, the standard sends the material to the TDM test, and when both results are given, the instructions must state that the TDM result is the reference.

FFP mask classes are filtration and leakage limits

EN 149:2001+A1:2009 classes a filtering half mask by how much it filters and how much air leaks in around it (SATRA). The class must be printed on the mask with the standard and any use codes, for example FFP2 NR D.

NR marks a single-shift mask and R a reusable one. D means the mask passed the dolomite dust clogging test, which is optional for NR masks and mandatory for R masks. Every filtering mask is Category III, so the CE marking carries a Notified Body number.

What the technical file must hold

Annex III sets the minimum content of the technical documentation, drawn up before the conformity assessment:

• A complete description of the PPE and its intended use

• An assessment of the risks it is meant to protect against

• The essential health and safety requirements that apply

• Design and manufacturing drawings, with the explanations needed to read them

• The harmonised standards applied, and which parts where they were applied only partly

• Calculations, inspections and test reports that show conformity and set the protection class

• How production is controlled so each unit matches the approved design

• A copy of the manufacturer's instructions and information under Annex II, point 1.4

Six mistakes that cost a PPE certificate

• Self-declaring a work glove as Category I. Only superficial pricks, weak cleaning materials, heat up to 50 °C, sunlight and mild weather qualify. Any claim beyond that needs a Notified Body.

• Testing to a withdrawn edition. Since 21 Apr 2019, gloves for mechanical protection must be certified to the state of the art, EN 388:2016 (SATRA).

• Changing the material without telling the Notified Body. A new shell yarn or coating can change cut and abrasion results, and it needs an addition to the certificate.

• Missing the renewal window. An application made less than 6 months before expiry breaks the rule in Annex V, and new stock cannot be placed on the market under an expired certificate.

• Marking a Category III product with CE alone. Respirators and chemical gloves need the Notified Body number after the CE marking.

• Relying on a voluntary certificate. A body acting outside its notification can issue a document that looks official, and EU law does not accept it as proof of compliance (European Commission).

Tti Labs tests and inspects PPE, and a Notified Body issues the certificate

Tti Labs runs ISO/IEC 17025 accredited testing under PNAC accreditation LAB-022. The accredited scope lists PPE methods including EN 388:2016+A1:2018 abrasion, blade cut, tear and puncture, ISO 13997:2024, the six EN 407:2020 thermal tests, EN 12477, EN ISO 21420 sizing and dexterity, EN 13594 and EN 17092 for motorcycle gloves and garments, EN ISO 20344 toe-cap impact, and EN ISO 20471 chromaticity.

Tti Inspections, accredited to ISO/IEC 17020 under PNAC IB-006, inspects PPE gloves, garments, face masks and footwear against the purchase order and the buyer's specification. The PPE team also helps prepare technical files and coordinates with Notified Bodies.

Tti Labs is not a Notified Body. The EU type-examination certificate, and the decision behind the CE marking for Category II and III, sit with a body notified under Regulation (EU) 2016/425 for that product. Contact Tti Labs to scope a PPE test programme.

Book PPE testing and inspection with Tti Labs.

Related guides: Which Certificates Win the Order, and What They Cost, Lab Testing for Pakistan Exports: What Buyers Need to Verify.