United States market note. FDA 510(k) K072145 covers patient examination gloves under 21 CFR 880.6250, and the cleared scope includes powdered latex examination gloves. FDA’s absorbable-powder final order (81 FR 91722, 19 December 2016) removed powdered patient examination gloves from the United States market with effect from 18 January 2017. Jiali therefore does not supply powdered latex examination gloves into the United States. For US-bound orders we supply nitrile examination gloves or powder-free latex examination gloves. Powdered latex examination gloves continue to be manufactured for markets where they may lawfully be sold; confirm the rules in your market with us before ordering.
Regulatory note on what our CE certificates are. The CE certificates we publish are EU-Type Examination certificates issued by CTC Groupe (Notified Body 0075) under the Personal Protective Equipment Regulation (EU) 2016/425. They are not a conformity route under the Medical Devices Regulation (EU) 2017/745 and do not substitute for one, and “medical-grade” is a marketing phrase with no standing in either regulation. If the gloves must be placed on your market as medical devices, tell us the country and the intended use and we will confirm which documentation exists before you order.
Zhanjiang Jiali Glove Products Co., Ltd. — Founded in 1998 with 9 automated dipping lines, manufacturing certified examination-grade disposable nitrile examination gloves in both powdered and powder-free series for international hospital procurement, dental clinics, cleanroom laboratories, and food handling facilities.
Our complete series of disposable nitrile examination gloves (Ref. Model JNE / JNEB Series: JNEB-1 Powdered, JNEB-2 Powder-Free, and JNEB-3 Ultra-Thin Powder-Free) are precision-dipped from high-purity synthetic nitrile polymer. Engineered to be 100% latex-free with zero natural rubber proteins, these gloves provide an optimal protective barrier against microorganisms, accidental chemical splashes, and biological fluids while delivering superior tactile dexterity.
Key Features of Disposable Nitrile Examination Gloves
- Dual Formulation Options (Powdered & Powder-Free): Available in JNEB-1 (lightly powdered with modified cornstarch for rapid damp-hand donning) and JNEB-2 / JNEB-3 (100% powder-free polymer-coated for lint-free medical and food safety).
- Official EU CE EU-Type Examination certification: Certified under PPE Regulation (EU) 2016/425 by CTC France (Notified Body 0075, Certificate No. 0075/2236/162/10/22/1808) valid through October 10, 2027.
- Microorganism Barrier Protection: Certified compliant with EN ISO 374-5:2016 and EN ISO 21420:2020 standards, ensuring reliable resistance against microbial penetration.
- Micro-Textured Fingertips: Textured fingertip surface delivers enhanced wet and dry grip for handling clinical instruments, test tubes, and delicate electronics.
- Latex-Free Hypoallergenic Safety: Eliminates the risk of Type I natural rubber latex allergies for medical staff, patients, and cleanroom operators.
B2B Technical Specifications & Container Loading Data
| Technical Attribute | JNEB-1 (Powdered 4.0 mil) | JNEB-2 (Powder-Free 4.0 mil) | JNEB-3 (Powder-Free 2.8 mil) |
|---|---|---|---|
| Product Classification | Powdered Nitrile Exam Gloves | Powder-Free Nitrile Exam Gloves | Ultra-Thin Powder-Free Nitrile |
| Factory Article Code | JNEB-1 | JNEB-2 | JNEB-3 |
| Primary Elastomer | 100% Synthetic Nitrile Rubber (Latex-Free / Protein-Free) | ||
| Surface Treatment | Lightly Powdered (USP Cornstarch) | 100% Powder-Free (Polymer Coated / Chlorinated) | |
| Standard Glove Length | 240 mm (24 cm / 9.5 Inches) | Beaded Rolled Cuff | ||
| Palm Thickness | 4.0 mil (0.1016 mm) | 2.8 mil (0.0711 mm) | |
| Weight per Piece (S / M / L / XL) | S: 4.5g | M: 5.0g | L: 5.5g | XL: 6.0g | S: 3.2g | M: 3.5g | L: 3.8g | XL: 4.1g | |
| Standard Packaging | 100 pcs/dispenser box, 10 or 20 boxes/master carton (Carton: 53 × 27.5 × 33 cm) | ||
| 20GP Container Capacity | 600,000 pcs (pieces) | 675,000 pcs (pieces) | |
| 40GP Container Capacity | 1,210,000 pcs (pieces) | 1,400,000 pcs (pieces) | |
| 40HQ Container Capacity | 1,415,000 pcs (pieces) | 1,650,000 pcs (pieces) | |
| Export Supply Terms | MOQ: 1 × 20GP Container | FOB Zhanjiang | ||
Loading figures are reference values. How many pairs fit a container depends on carton dimensions, whether the load is loose-packed or palletised, inner-box choice, size mix and gram weight, so the number changes with your specification. Use the figures for planning and confirm the exact quantity for your specification with us before the order is placed.
Medical, Laboratory & Industrial Applications
- Healthcare & Medical Examination: Outpatient diagnostics, patient care, dental examinations, veterinary medicine, and emergency response.
- Clinical & Biochemical Laboratories: Handling blood samples, diagnostic test kits, laboratory reagents, and analytical pipettes.
- Food Processing & Commercial Catering: Meat cutting, dairy handling, commercial kitchen food preparation, and bakery packaging (especially JNEB-2 / JNEB-3 powder-free series).
- Cleanrooms & Precision Manufacturing: Electronics assembly, optical lens cleaning, and pharmaceutical packing lines.
Quality Verification & International Compliance
- Official CTC European CE Verification: EU Type-Examination certified under Module C2 by CTC France (Notified Body 0075, Certificate 0075/2236/162/10/22/1808).
- REACH & Biological Safety: Fully compliant with Annex XVII of EU REACH Regulation (EC No. 1907/2006) and EN ISO 374-5 microorganism penetration benchmarks.
- AQL 1.5 Quality Protocol: every production lot is air-leak pressure tested against an AQL 1.5 freedom-from-holes sampling plan (ISO 2859-1), with batch results recorded and shipped with the container.
Why Partner with Jiali Glove Products?
- Dedicated Manufacturing Since 1998: Nearly 30 years of specialized dipping expertise with an annual capacity exceeding 180 million pairs.
- 9 Automated Dipping Lines: Stable supply capability supporting continuous high-volume container shipments worldwide.
- Comprehensive OEM & Private Label Solutions: Fully customized medical dispenser boxes, multi-lingual outer cartons, custom weight specs, and international barcode compliance.
Frequently Asked Questions (FAQ)
Q: What is the main difference between your powdered (JNEB-1) and powder-free (JNEB-2 / JNEB-3) disposable nitrile examination gloves?
A: JNEB-1 uses USP-grade cornstarch lubricant for ultra-fast donning in humid or sweaty conditions. JNEB-2 (4.0 mil) and JNEB-3 (2.8 mil) undergo specialized online polymer coating/chlorination to eliminate 100% of powder, making them ideal for lint-free medical exams, cleanrooms, and food handling.
Q: What are the container loading quantities for a 20GP, 40GP, and 40HQ container?
A: For standard 4.0 mil models (JNEB-1 & JNEB-2), container loading is 600,000 pcs (20GP), 1,210,000 pcs (40GP), and 1,415,000 pcs (40HQ). For the lightweight 2.8 mil series (JNEB-3), loading is 675,000 pcs (20GP), 1,400,000 pcs (40GP), and 1,650,000 pcs (40HQ).
Q: Can we customize our own brand retail dispenser box and outer carton artwork?
A: Yes. We offer comprehensive OEM/ODM private label packaging services. The standard custom artwork MOQ is 1 × 20GP container per specification.
Global Wholesale & Custom OEM Inquiries for Disposable Nitrile Examination Gloves
Zhanjiang Jiali Glove Products Co., Ltd. supplies high-volume distributors worldwide from our 57,000 m² automated facility. In addition to examination gloves, we manufacture heavy-duty Green Nitrile Industrial Gloves, lint-free White Unlined Nitrile Gloves, and heavy-duty Black Orange Industrial Gloves. Contact our international export sales team today for container load quotations and factory sample boxes.
Certification & Compliance
- US FDA 510(k) Cleared (K072145): patient examination glove under 21 CFR 880.6250 — substantial equivalence decided 2008-02-26.
- CE EU-Type (0075/2236/162/10/22/1808): micro-organisms (EN ISO 374-5), Notified Body 0075 (CTC), valid to 2027-10-10.
- EN 455 Series & ASTM Validated: EN 455-1 (no holes) / 455-2 (physical) / 455-3 (biological) by TÜV; ASTM D6319 material and ASTM D6978 chemotherapy-drug permeation tested by SGS.
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