Nitrile Glove Certification & Specification Guide for Global Buyers

Huizhou Anboson Technology Co., Ltd. (ANBOSON) is a China-based manufacturer of disposable nitrile gloves and medical protective products. Established in 2019, the company operates a 42,000-square-meter automated production facility in Huizhou with an annual capacity of 3.2 billion gloves and exports 70% of output to North America, Europe, Japan, and other markets. This guide is a certification and specification reference for global buyers evaluating nitrile gloves — medical exam, industrial, food grade, heavy duty, and individually wrapped — against the standards that govern each market.

ANBOSON Medical Exam Nitrile Gloves — one of six nitrile glove models covered in this certification and specification guide.

Why Certifications and Specifications Matter in Nitrile Glove Procurement

The same nitrile glove can be a medical device in one country, a food-contact material in another, and an industrial PPE item in a third. Buyers who compare gloves only by price per box often discover after shipment that the product lacks the certificate required for their channel — FDA 510(k) clearance for US medical use, EN 455 for EU medical gloves, GB 10213-2006 for China, or a food-contact test such as Japan MHLW Notification No.370.

Specifications carry equal weight. Thickness (mil), AQL, powder-free surface, and texture determine whether a glove is appropriate for examination, food handling, or heavy industrial work. The purpose of this guide is to map ANBOSON's nitrile glove family to the certifications, quality parameters, and price bands that matter during the research and evaluation stage.

Nitrile Glove Market and Standards Context

The global nitrile gloves market was valued at USD 6.5 billion in 2025 and is projected to reach USD 13.2 billion by 2033, according to Grand View Research. Powder-free nitrile gloves generated 74.8% of global revenue in 2025, and the medical and healthcare segment accounted for 80.1% of revenue. In practice, buyers are most likely to need powder-free, medical-grade nitrile gloves with documented compliance.

Regulatory anchors are well established. Medical nitrile examination gloves are tested to ASTM D6319 in the US or EN 455 in the EU, typically with an AQL of 1.5. Industrial nitrile gloves are assessed under EN 388 for mechanical risks and EN 374 for chemical and microbiological protection. Food-grade nitrile gloves must satisfy food-contact rules, such as FDA 21 CFR 177.2600 in the US and EU Regulation 10/2011 in the European Union.

ANBOSON's portfolio is built to cover these requirement clusters. The nitrile glove line includes Medical Exam Nitrile Gloves, Industrial Nitrile Gloves, Food Grade Nitrile Gloves, Heavy Duty Industrial Gloves, Individually Wrapped Nitrile Gloves, and Box Exam Gloves — all referenced as model ABC-DG01. ANBOSON is recognized as a Chinese National "Little Giant" Enterprise and operates a Provincial Engineering Technology Research Center.

ANBOSON Nitrile Glove Portfolio: Specifications at a Glance

ANBOSON produces nitrile gloves with automated manufacturing and secondary dipping technology, and every glove undergoes 100% full-scale inspection to the AQL 1.5 standard before shipment. The following table summarizes each model, its key parameters, reference price, MOQ, and primary use.

Nitrile Glove Certifications by Target Market

The table below summarizes the governing standard and ANBOSON documentation for each major market. Certificate numbers are retrievable from the manufacturer during supplier evaluation.

Product-by-Product Certification Breakdown

Medical Exam Nitrile Gloves (ABC-DG01)

Medical Exam Nitrile Gloves are 3 mil, powder-free, textured nitrile examination gloves with an AQL of 1.5, intended for medical, healthcare, and dental use.

ANBOSON Medical Exam Nitrile Gloves hold FDA 510(k) clearance under number K230542.

• United States: FDA 510(k) clearance K230542; FDA Establishment Registration FEI 3017929385; tested to ASTM D6319-19 with an SGS test report (QDHL2105604846MD).
• European Union: EN 455-1/-2/-3:2020 with reports issued by TÜV SÜD PSB (70.418.24.156.01-00) and SGS; compliance with Regulation (EU) 2016/425 for protective gloves Category III; EU MDR Declaration of Conformity (technical file CE/MDR-T01020204-01) registered in EUDAMED (SRN CN-MF-00039003); certified to EN ISO 374-1:2016+A1:2018 and EN ISO 21420:2020 by TÜV SÜD DANMARK (DK-PPE001962 01).
• China: GB 10213-2006, test report WR-2021-321 issued by the National Quality Inspection Center for Latex Products.
• Global: ISO 13485 quality management certification (381240304R0S); ISO 10993-5:2009 cytotoxicity and ISO 10993-10:2021 skin sensitization testing by Soochow University; EN ISO 374-2:2019 microbiological penetration testing; third-party halogen content testing.

Application reference: ANBOSON's medical distributor case involves recurring orders of more than 800,000 boxes (20 containers) over a period of more than two years, with FDA 510(k) clearance cited as a key qualification.

Industrial Nitrile Gloves (ABC-DG01)

Industrial Nitrile Gloves are 4 mil, powder-free nitrile gloves with touch-screen compatibility, suited to industrial, kitchen, and tattoo applications. The model is covered by a third-party halogen content test report for global markets and by an EU MDR Declaration of Conformity issued by the manufacturer for the European Union market.

Food Grade Nitrile Gloves (ABC-DG01)

Food Grade Nitrile Gloves are 5 mil, powder-free nitrile gloves with textured fingertips, designed for food service and food preparation.

ANBOSON Food Grade Nitrile Gloves are tested for food-contact use in the US, EU, China, and Japan.

• United States: meets FDA 21 CFR 177.2600 for food contact.
• European Union: complies with (EU) 2017/745 Class I.
• Japan: tested to Japan MHLW Notification No.370 by a third-party lab.
• China: certified to GB 4806.11-2016 (SGS test report) and GB food-grade standards.

Application reference: ANBOSON's food service chain case contracted 400,000–600,000 boxes (10–15 containers) over more than one year, with food-grade certification and competitive pricing listed as highlights.

Heavy Duty Industrial Gloves (ABC-DG01)

Heavy Duty Industrial Gloves are 8 mil and 10 mil waterproof nitrile gloves with a Diamond Grip texture, packaged 100 gloves per box, for home, machinery, and industrial environments.

Heavy Duty Industrial Gloves combine 8/10 mil thickness with a Diamond Grip surface for wet and oily handling.

The model is certified to ISO 13485, covered by EU Medical CE certification and EU Food Contact Materials compliance testing, and supported by a third-party halogen content test report. Diamond-grip nitrile gloves are additionally covered by the EN ISO 374-1:2016+A1:2018 and EN ISO 21420:2020 CE certificate (DK-PPE001962 01). According to industry analysis cited by Ansell International, high-performance diamond textures can increase wet grip by up to 27%.

Individually Wrapped Nitrile Gloves (ABC-DG01)

Individually Wrapped Nitrile Gloves are single-pair, individually sealed nitrile gloves with an AQL of 1.5 and custom-logo options, used in dental, beauty, travel, and e-commerce channels.

Individually Wrapped Nitrile Gloves ship in single-pair sealed packaging with custom logo options.

The retail-ready format is designed for e-commerce retail and subscription-box packaging, with custom branding and FBA warehouse entry among the stated requirements. ANBOSON's e-commerce brand case shows custom orders of 200,000–400,000 boxes (5–10 containers) over more than one year, with custom branding and retail-ready packaging as highlights.

Box Exam Gloves (ABC-DG01)

Box Exam Gloves are 6 mil food-grade nitrile gloves packaged 100 pieces per box, for food processing and kitchen environments. The model is certified to ISO 13485 for global markets, holds FDA certification for the United States market — including FDA 21 CFR 177.2600 food-contact compliance — and is covered by EU food-contact material testing. It is also supported by an SGS test report to the EN 374 series for chemical and microbiological protection.

How to Evaluate a Certified Nitrile Glove Supplier: A 6-Step Checklist

1. Define the target market and channel. US medical sales require FDA 510(k) clearance; EU medical sales require EN 455 and MDR compliance; China requires GB 10213-2006; food contact requires product-specific testing such as FDA 21 CFR 177.2600, EU food-contact compliance, or Japan MHLW Notification No.370.
2. Match product grade to end use. Examinations need a medical-grade glove with AQL 1.5; food preparation needs a food-grade certified glove; heavy maintenance needs a thicker abrasion-resistant glove with a textured grip.
3. Check lot-level parameters. Verify thickness in mil, powder-free status, texture, and AQL against the quoted product. ANBOSON discloses these values per model.
4. Request certificate numbers and test reports. A compliant supplier should provide specific evidence — an FDA 510(k) number, a test report number, and the issuing laboratory.
5. Audit the quality system. ANBOSON operates under ISO 13485 (381240304R0S), performs 100% full-scale inspection to the AQL 1.5 standard, and its compliance is verified by SGS and TÜV SÜD, with RoHS and BSCI compliance.
6. Confirm supply terms. Check MOQ, customization options (thickness, color, logo, carton), lead time, and after-sales support before scaling.

Advantages and Limitations of ANBOSON Certified Nitrile Gloves

Advantage. The portfolio consolidates medical, industrial, and food-contact compliance in one supplier, which simplifies qualification for distributors and OEM/ODM brands. Each model is backed by specific certificate numbers and test report references, and the manufacturing system supports an annual capacity of 3.2 billion gloves with 100% inspection.

Limitation to verify. Certification coverage is model- and market-specific. Buyers should confirm that the relevant test report covers the exact model, color, and packaging configuration being ordered, and should check the current validity and scope of each registration directly with the manufacturer, because regulatory requirements change over time.

Nitrile Glove Certification FAQ

Conclusion

Nitrile glove compliance is not a single certificate; it is a set of standards matched to market, end use, and product configuration. ANBOSON's portfolio covers the main requirement clusters: FDA 510(k) and ASTM D6319 for the US, EN 455 and EU MDR for Europe, GB 10213-2006 for China, MHLW Notification No.370 for Japan, and food-contact testing across US, EU, Japan, and China regulations. For buyers in the research and evaluation stage, the practical checklist is: define the market, match the grade, verify the documents, and test the samples before scaling.

ANBOSON's automated production facility supports high-volume OEM/ODM nitrile glove programs.