Here is the conclusion up front: glove test reports issued to Chinese national standards generally cannot be reused as they stand for the EU. Not because the national standards are lenient, but because the two systems do not examine an identical set of characteristics. Biological evaluation and shelf life in particular have dedicated parts in EN 455 and no direct counterpart in the national system.
Map the two systems onto each other first, then decide what can be reused and what has to be repeated.
The four parts of EN 455
| Part | Current edition | What it covers | Approximate domestic counterpart |
|---|---|---|---|
| EN 455-1 | 2020 | Freedom from holes, that is, whether the glove has pinhole-type defects | The watertightness requirement in GB 10213 / GB 7543 |
| EN 455-2 | 2024 | Physical properties, principally dimensional and tensile characteristics | The dimensional and physical property requirements in GB 10213 / GB 7543 |
| EN 455-3 | 2023 | Requirements relating to biological evaluation | No direct counterpart part; organized separately under the GB/T 16886 system |
| EN 455-4 | 2009 | Determination of shelf life | No direct counterpart part |
Note that EN 455-1 and EN 455-2 have both been revised in recent years, in 2020 and 2024 respectively, and EN 455-3 has moved to a 2023 edition. If the EU report in your file was issued to an earlier edition, confirm before you ship that the target market still accepts it, particularly where you are planning to reuse a report that is a few years old.
Holes and physical properties: the reusable half
EN 455-1 looks for through-thickness defects. The approach matches the watertightness requirement in the national standards, filling the glove with water and observing for leakage, judged against a defined sampling plan.
EN 455-2 covers dimensional and tensile characteristics. Whether those characteristics are maintained across the claimed shelf life is answered by the shelf life work in EN 455-4. The two parts are designed to work together, with the assessment method given by EN 455-2 and the way the claimed period is determined given by EN 455-4.
These two parts share their thinking with GB 10213 for single-use medical examination gloves, GB 7543 for single-use sterile rubber surgical gloves, and internationally with ISO 11193 and ISO 10282. Shared thinking is not equivalence, though. Sampling plans, acceptance limits and specimen preparation details differ between standards, and specific limits are governed by each standard in its currently effective version. The practical move is to run a fresh report to the EN 455 scheme rather than argue conformity from a national standard report, because the latter requires a clause-by-clause equivalence justification that usually costs more effort than simply retesting.
Biological evaluation: the part most often missing
EN 455-3 is what manufacturers most often leave out of an EU file. It addresses the biological risks a glove can present to wearer and patient, and the topics involved include:
- Powder. Requirements differ for powdered and powder-free gloves, and a product labelled powder-free has to demonstrate that residue is controlled.
- Natural rubber latex proteins. Natural latex gloves carry a protein sensitization risk, and extractable protein is the focus for this material family.
- Chemical residues. Residual processing aids such as vulcanization accelerators can provoke contact dermatitis.
- Labelling and information. Information relating to the risks above has to appear on the label or in the instructions for use.
This work complements conventional biocompatibility evaluation rather than replacing it. EN 455-3 has to be satisfied, and the biological evaluation required under the GB/T 16886 (ISO 10993) system still has to be done. Both reports belong in the technical documentation. For the combination of tests involved, see biocompatibility testing.
Nitrile and other synthetic gloves are not exposed to the natural latex protein issue, but the chemical residue and powder requirements still apply. Changing material does not make this part go away.
Shelf life: not a single sentence about accelerated aging
EN 455-4 sets out how the claimed shelf life is determined. The core requirement fits in one line: the expiry date printed on your packaging has to be supported by data.
There are two routes in practice.
Real-time aging is the most direct evidence. Hold product for the claimed period, then test whether the critical characteristics still conform. The problem is calendar time: claim three years and you wait three years.
Accelerated aging is used to provide support before the real-time data matures, so that the product can reach the market. But accelerated aging is an extrapolation and cannot stand alone as the final basis. The usual approach is accelerated data first, the real-time study started in parallel, and confirmation added as it matures.
Note also that shelf life work covers the packaging as well as the glove itself. The sterile barrier system of a sterile surgical glove has to remain intact across the claimed period, which couples this work to packaging validation. See shelf life and aging.
Sterile and non-sterile: different compliance routes
Examination gloves are usually supplied non-sterile and surgical gloves usually sterile, and the two follow different routes in the EU.
An honest warning about classification. The class a glove falls into under the EU medical device regulation has to be determined case by case, following the classification rules in the annex of the regulation together with the intended purpose of the specific product. It cannot be copied from a competitor's brochure. If the product ends up in a given class because it is supplied sterile, the extent of notified body involvement differs from the non-sterile case. Get the classification confirmed in writing by your EU representative or notified body before you build a test plan around it, because a wrong classification makes both the test list and the conformity assessment route wrong.
This is not boilerplate. Applying a non-sterile route to a sterile product ends with technical documentation sent back for rework, not with one extra report.
Samples and documentation
For protocol design, provide:
- Product type and sterility status: examination or surgical glove, and the sterilization method used
- Material system: natural latex, nitrile, polyisoprene or other, and whether the glove is powdered
- Sizes in scope: how many sizes fall inside the declared range, since size variation affects physical property sampling
- The claimed shelf life, and whether any real-time aging data already exists
- Packaging format: for sterile product, the primary packaging drives the shelf life protocol
- Target markets and existing reports: national standard or ISO reports already in hand are useful inputs to protocol design
Sample quantity depends on the number of parts in scope, the number of sizes and the sampling plan, and a definitive list is issued once the protocol is agreed. Start the shelf life work as early as you can. It has the longest lead time in the project and often decides when the product can be placed on the market. For scope on other device categories see other medical device testing, and comparable projects are described under case studies.
Working with SUNGO Lab
SUNGO Lab (Shanghai Shage Medical Technology Co., Ltd.) is accredited by CNAS, CMA and IAS (USA), with laboratories in Shanghai and Hefei. We take on physical property, biological evaluation and shelf life work for medical gloves, and can issue reports in the formats expected by your target export markets. The full scope is listed under testing services. Accreditation marks demonstrate technical competence within the accredited scope; they are not a commitment regarding market access.
If you are unsure which parts you still have to run, whether your existing national standard reports can be reused, or how to schedule the shelf life work, send us the product documentation and the reports you already hold and we will confirm a protocol first. Call +86 132 4819 8029 or request a quote.