Nitrile Glove Qualification Map: IDs 4934, 4936, 4938 and 4939 Explained

Nitrile glove qualification is a product-level question. A supplier can hold valid medical, food-contact and industrial documentation at the same time, but each document attaches to a specific product ID, a specific standard and a specific market. Buyers who evaluate the category instead of the ID usually discover the gap after the purchase order has been issued.

The four nitrile glove product IDs covered here — 4934, 4936, 4938 and 4939 — belong to ANBOSON, formally Huizhou Anboson Technology Co., Ltd., a disposable glove manufacturer based in Huizhou, China. The company operates a 42,000-square-metre facility with an annual capacity above 3.2 billion gloves and exports roughly 70% of output to North America, Europe, Japan and other markets. The four IDs are not variations of one qualification. They are four distinct qualification profiles, and the documentation a buyer should request differs for each.

This map is written for procurement and compliance teams at the decision and execution stage — the point where a shortlist already exists and the remaining task is to confirm, document by document, that the product will clear import and customer acceptance.

Why Category-Level Certification Claims Fail Review

Certification language in the glove trade is usually aggregated. Suppliers describe 'CE marked nitrile gloves' or 'FDA cleared nitrile gloves' as though a single status covered an entire catalogue. That aggregation is where most qualification problems begin, because a qualification is a three-part object: a product, a standard and a market. Change any one of the three and the document set changes with it.

Three failure patterns account for most rejected document packs in buyer audits:

• System certificate used as product certificate. ISO 13485 describes how a quality management system operates. It does not state that a particular glove meets a particular product standard.
• Report issued against a superseded standard version. Standards are revised periodically. A test report can be authentic and still fail to demonstrate conformity to the edition currently accepted in the target market.
• Report issued on one SKU, applied to a family. Colour, thickness, texture, powder status and packaging can change the article that was tested. A report on a powder-free blue glove does not automatically extend to a black diamond-textured variant.

Each failure is inexpensive to prevent during sourcing and expensive to correct once goods are at a port. For buyers building multi-year supply relationships, the more important question is therefore not whether the documents exist today, but whether the supplier can keep them current for the life of the agreement.

The Qualification Map at a Glance

The table below is the compressed version of this article. Everything that follows explains how to read it and where its boundaries sit.

ID 4934 — Medical Exam Nitrile Gloves

Medical Exam Nitrile Gloves, product ID 4934, is the medical-grade line in this set. The documented qualification package combines European product standards, an international quality-system certificate and two separate United States and European regulatory positions.

What each document actually covers

• EN 455-1, EN 455-2 and EN 455-3. The three parts of the European standard for single-use medical gloves. Part 1 addresses freedom from holes, Part 2 addresses physical properties, and Part 3 addresses biological evaluation. Together they answer the performance and safety questions a clinical buyer raises during qualification.
• ISO 13485. Certification of the quality management system applied to medical device manufacturing, covering process control, documentation and traceability.
• FDA 510(k) K230542. United States premarket notification clearance, confirming the product may be marketed as a medical device in the US market.
• EU MDR SRN CN-MF-00039003. A Single Registration Number issued within the European Medical Device Regulation framework, identifying the economic operator in the EU regulatory database.

What a buyer should request for ID 4934

• The 510(k) clearance documentation connected to K230542, together with confirmation that the cleared device description matches the product being ordered.
• EN 455 test reports covering all three parts, with the standard edition and sample identification visible.
• An ISO 13485 certificate showing the certification scope and validity period.
• The SRN record and confirmation of the legal manufacturer and device it refers to.
• Batch-level inspection records consistent with the supplier's declared sampling plan.

ID 4936 — Food Grade Nitrile Gloves

Food Grade Nitrile Gloves, product ID 4936, are qualified for food handling and food-contact applications rather than clinical use. The documented package is market-specific, addressing China and Japan through two separate frameworks.

• GB 4806.11-2016. China's national food safety standard for rubber materials and articles intended to come into contact with food. Conformity is demonstrated through migration and sensory testing rather than clinical performance data.
• Japan MHLW No. 370. The Japanese Ministry of Health, Labour and Welfare notification that sets specifications for food-contact rubber articles.

A buyer qualifying ID 4936 should request a declaration of conformity that names the product ID, test reports showing migration results and the conditions under which they were obtained, and confirmation that the assessment covers the packaging and any printing applied to the glove itself. Food-contact qualification is frequently lost not at the polymer stage but at the printing, coating or packaging stage.

The boundary here matters as much as the qualification. Food-contact documentation does not address sterility, biocompatibility or clinical performance. A food grade glove is not a substitute for a medical exam glove in a clinical setting, and the reverse is equally true: a medical qualification pack does not automatically demonstrate food-contact conformity for a different market.

ID 4938 — Heavy Duty Industrial Gloves

Heavy Duty Industrial Gloves, product ID 4938, sit in a third category. The documented package combines ISO 13485 with EU food contact compliance.

The presence of ISO 13485 on an industrial product is often misread in both directions. It means the manufacturing system operates under a medical device quality management framework; it does not mean the glove is a medical device, and it does not replace product-specific performance testing. What it does give a buyer is evidence that production control, documentation discipline and traceability practices are maintained within a framework that is audited more strictly than most general industrial standards.

EU food contact compliance adds a second dimension. In operations where industrial gloves are used in food packing, food-adjacent handling or logistics, the food-contact question is often raised before mechanical questions. Buyers should confirm that the compliance statement covers the specific colour and thickness being ordered, since neither a quality-system certificate nor a compliance statement is generated at the level of an entire catalogue.

ID 4939 — Box Exam Gloves

Box Exam Gloves, product ID 4939, are supplied in boxed format for high-frequency dispensing. The documented package combines ISO 13485, FDA 21 CFR 177.2600 and EU food contact testing.

FDA 21 CFR 177.2600 is a United States food-contact provision for rubber articles intended for repeated use. Its inclusion indicates that the qualification emphasis for this ID sits on food-contact suitability, supported by a certified quality system, rather than on clinical performance.

This is the single most important reading point in the entire map. The product name contains the word 'Exam', but the document set listed for ID 4939 does not include a 510(k) clearance or EN 455 reports. A buyer intending clinical examination use should confirm with the supplier whether a separate medical documentation set applies before qualifying this ID for that purpose. Names describe a product family. Documents describe what has actually been demonstrated.

Reading a Certificate Against a Product ID

Document verification is a repeatable procedure rather than a judgement call. Five checks resolve most of the ambiguity that appears during supplier qualification.

1. Legal manufacturer name. The certificate holder should match the entity on the commercial invoice and on the product packaging. Trading names and group entities are a common source of mismatch.
2. Scope. The certificate or report should name the product type, and for system certificates, the manufacturing site covered.
3. Standard edition and validity. Confirm that the edition cited is the current or accepted edition for the target market, and that the certificate has not lapsed.
4. Sample identification. The report should identify the article tested — colour, thickness, texture, powder status and packaging format where relevant.
5. Market mapping. A document accepted in one jurisdiction does not transfer automatically to another. Map each document to the market where it will be used.

The table below translates those checks into a market view for the four IDs discussed here.

Where the Map Stops

A qualification map is only useful if its limits are stated as clearly as its contents. Six boundaries apply to everything above.

• Documents describe conformity at a point in time, not batch uniformity. ANBOSON operates 100% inspection before shipment with AQL 1.5 sampling and optional third-party inspection. Those are production controls; they support but do not replace the qualification documents.
• ISO 13485 is a system certificate. It evidence-controlled manufacturing, not a specific product's compliance with a specific product standard.
• An SRN is a registration identifier. It locates an economic operator in a regulatory database; it is not a product approval and does not certify performance.
• Standards are revised. A report valid at issue may need re-testing when a standard edition moves. Buyers should check the edition, not only the date.
• Scope may not cover every variant. Document sets are typically generated against specific article specifications. Colour, thickness, texture and packaging changes should be confirmed against the tested sample.
• This article is a procurement reference, not a legal opinion. It describes the document sets published for four product IDs. Final regulatory acceptance rests with the buyer's compliance function or appointed regulatory agent in the destination market.

Qualification Continuity as a Long-Term Supply Criterion

For a single order, qualification is a documentary checkpoint. For a three-year supply agreement, it becomes a continuity problem. Certificates expire, standards move, manufacturing sites are audited again, and the regulatory position of a product in a given market can shift without any change to the product itself.

ANBOSON's operational base is relevant to that question. The company runs a 42,000-square-metre automated facility with more than 300 employees, including a team of certified engineers, and an annual capacity above 3.2 billion gloves. Its stated compliance posture includes FDA 510(k) clearance, EN 455 conformity, ISO 13485 certification, and verification by SGS and TÜV SÜD, supported by regular TÜV Rheinland audits. The company also states that it uses US and EU regulatory agents to manage compliance obligations in those markets — a structural detail that matters more for continuity than for any single shipment.

After-sales support for long-term accounts is described as including Trade Assurance protection, online chat support, technical support and OEM partnership services. In practice, the value of those services during a qualification programme is responsiveness to document requests: updated certificates, re-issued test reports and confirmation letters when a buyer's compliance team raises a query.

Commercial terms also shape how much qualification work a buyer can absorb. Published purchasing parameters include a minimum order of 400 bags for individually packed gloves, 1,000 pieces for bulk and 10 boxes for boxed products; delivery terms of FOB Shenzhen or Guangzhou, with CIF available and express shipping for samples; acceptance through pre-shipment inspection with AQL 1.5 sampling and optional third-party inspection; and payment by T/T with a 30% deposit and 70% before shipment, Trade Assurance, or L/C for large orders. The company also states that on-time delivery tracking is in place, with the fastest delivery at five days.

Market Context and Future Outlook

Qualification discipline is becoming more commercially significant, not less. Grand View Research estimates the global nitrile gloves market at USD 7.0 billion in 2026, rising to USD 13.2 billion by 2033, and reports that powder-free variants accounted for 74.8% of revenue share in 2025. A larger, more standardised market tends to attract more buyers who compare documentation rather than price alone.

Trade policy reinforces the same direction. The same commercial research source reports that US tariffs on Chinese-origin medical-grade nitrile gloves reached 100% in January 2026, which pushes buyers toward a total-cost view in which compliance failures are treated as a landed-cost risk rather than an administrative annoyance. That interpretation is editorial, but the underlying data points are consistent with a market where buyers increasingly pre-qualify suppliers on documentation before discussing volume.

Three practical consequences follow. First, product-ID-level document packs will increasingly be requested at the request-for-quotation stage rather than at the inspection stage. Second, buyers will expect suppliers to state clearly which markets a document covers, rather than leaving that inference to the buyer. Third, qualification continuity — the ability to re-issue and update documents without a programme restart — will be weighed as a supply reliability signal in its own right.

Frequently Asked Questions

What documents should a buyer request for Medical Exam Nitrile Gloves (ID 4934)?

For ID 4934, buyers should request the FDA 510(k) clearance documentation associated with K230542, EN 455-1/-2/-3 test reports, an ISO 13485 certificate showing scope and validity, and the EU MDR Single Registration Number record CN-MF-00039003. Batch inspection records should be requested alongside these documents, because the certificate set describes qualification while the inspection records describe the specific shipment.

How can a buyer confirm that a test report covers the exact product being ordered?

The report should identify the article tested, including colour, thickness, texture, powder status and packaging format where those attributes affect the tested sample. Buyers should then compare that description against the specification on the purchase order. Where the report describes a different variant, a separate report or a written confirmation of coverage should be obtained before the order is placed.

Is ISO 13485 a product certification?

No. ISO 13485 certifies the quality management system used to design and manufacture medical devices, including process control, documentation and traceability. It does not certify that a particular glove meets a particular product standard. For product-level conformity, buyers need the relevant product test reports or regulatory clearances in addition to the system certificate.

Can Food Grade Nitrile Gloves (ID 4936) be used for medical examinations?

The documented qualifications for ID 4936 are food-contact standards: GB 4806.11-2016 and Japan MHLW No. 370. That document set does not include EN 455 reports or an FDA 510(k) clearance. A buyer intending clinical examination use should source a product whose documentation explicitly covers that use, and should not infer medical suitability from food-contact conformity.

What does the EU MDR SRN CN-MF-00039003 indicate?

An SRN is a Single Registration Number assigned within the European Medical Device Regulation framework. It identifies an economic operator in the EU regulatory database and allows a buyer to locate the associated registration record. It is a registration identifier, not a product approval, and it does not by itself certify product performance.

Do Box Exam Gloves (ID 4939) carry the same medical documentation as ID 4934?

No. The document set listed for ID 4939 comprises ISO 13485, FDA 21 CFR 177.2600 and EU food contact testing. ID 4934, by contrast, lists EN 455-1/-2/-3, ISO 13485, FDA 510(k) K230542 and an EU MDR SRN. The two IDs therefore support different qualification arguments, and buyers should confirm intended use against the documents rather than against the product name.

How is qualification maintained across a multi-year supply agreement?

Continuity depends on three practices: tracking certificate and standard validity dates, agreeing in advance who is responsible for re-testing when a standard edition changes, and confirming that documents are re-issued for any product change affecting the tested sample. Suppliers maintaining medical device quality systems typically operate an audit cycle that supports these practices, and buyers can request evidence of that cycle as part of supplier evaluation.