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.
Global Compliance
Every certificate is a solemn commitment to quality and compliance — proof that our products meet global market standards and a solid foundation for your business success.
From Quality Management System certification to environmental and safety compliance, from industry-specific certifications to international trade credentials, each certificate reflects our relentless pursuit of excellence and strict adherence to global market access requirements.
These certifications are more than documents — they are proof of our commitment to stand alongside you, entering global markets and earning the trust of buyers worldwide.
Strict Raw Material Inspection
With a deep understanding of how rubber compounds transform from liquid to solid, we precisely control key process parameters — including temperature, time, and viscosity — to ensure stable and reliable product performance.
- Temperature Control: Ensures a stable vulcanization process
- Time Control: Guarantees precision at every production stage
- Viscosity Control: Maintains uniformity and consistent thickness
Finished Product Inspection (Safety Testing)
Traditional Method: Each batch of finished products is sampled using professional leak testing equipment for inflation inspection.
Technology Upgrade: We have introduced an optical inspection system that automatically detects micro-pinholes, internal defects, and particles — improving detection accuracy and efficiency.
Core Commitment: We strictly follow our inspection process, because product quality is directly tied to our customers’ brand reputation.
Finished Product Inspection (Performance Testing)
Weight & Thickness Control
Process: Multiple rounds of weight and thickness monitoring — from compounding and random line checks to post-drying and pre-packaging re-inspection.
| Product Type | Weight Range | Tolerance |
|---|---|---|
| Flocked Latex Gloves | Under 50g | ±2g |
| Flocked Latex Gloves | Over 50g | ±3g |
| Nitrile Flock-Lined Gloves | Over 59g | ±3g |
* Partial examples shown. Please contact us for detailed tolerance specifications.
How We Control Glove Quality
Zhanjiang Jiali is a professional glove manufacturer operating since 1998, producing household rubber gloves, industrial latex gloves, nitrile gloves, and disposable gloves.
Sample Approval
Confirm samples, then plan production.
Order Process
Pre-production samples compared against approved specs.
Production
every production lot inspected before shipment under an ISO 2859-1 sampling plan (AQL 1.5 pinhole, AQL 4.0 cosmetic).
Shipping
Mass production complete with after-sales support.
One-Stop Glove OEM Manufacturer
Jiali provides one-stop glove OEM services — we won’t let you down!
Global Compliance — Every Claim Verifiable
We don’t just say “certified” — we publish certificate numbers, notified bodies and expiry dates so you can verify them independently. Current compliance portfolio of Zhanjiang Jiali Glove Products Co., Ltd. (est. 1998):
Management Systems
| Certification | Certificate No. | Body (Accreditation) | Valid |
|---|---|---|---|
| ISO 9001:2015 — Quality | 05325Q30139R0M | NGV (CNAS C053-M / IAF) | 2025-01-14 → 2028-01-13 |
| ISO 14001:2015 — Environmental | 05325E30103R0M | NGV (CNAS C053-M / IAF) | 2025-01-14 → 2028-01-13 |
CE — EU-Type Examination (Notified Body 0075, CTC France · COFRAC 5-0504)
| Product (Code) | Certificate No. | Category | Standards | Valid |
|---|---|---|---|---|
| Blue nitrile exam (JNE) | 0075/2236/162/10/22/1808 | — · micro-organisms | EN ISO 21420:2020 · EN ISO 374-5:2016 | → 2027-10-10 |
| White nitrile exam (JNEL) | 0075/2236/162/10/22/1807 | — · micro-organisms | EN ISO 21420:2020 · EN ISO 374-5:2016 | → 2027-10-10 |
| White latex exam (JLEI) | 0075/2236/162/10/22/1813 | micro-organisms | EN ISO 21420:2020 · EN ISO 374-5:2016 | → 2027-10-18 |
| Green nitrile industrial (JNI) | 0075/2236/162/02/25/0282 | Cat III · mech/chem/micro/radioactive | EN ISO 21420 · EN 388 4101X · EN ISO 374-1/-5 Type A · EN 421 | → 2030-02-11 |
| Household latex (JLHL) | 0075/2236/162/04/21/0798 | Cat II · mech/micro | EN ISO 21420 · EN 388 1120X · EN ISO 374-5 | → 2031-05-03 |
United States — FDA
- FDA 510(k) clearance K072145 — patient examination gloves (latex / nitrile, powdered & powder-free), 21 CFR 880.6250, substantial equivalence decided 2008-02-26 — the powdered configuration has not been supplied for the United States since 18 January 2017. A 510(k) clearance carries no fixed expiry.
Social & Environmental
| Scheme | Certificate / ID | Body | Valid |
|---|---|---|---|
| amfori BSCI social audit | 25-0360964 · amfori ID 156-046732-000 | TÜV Rheinland | → 2026-11-28 |
| FSC Chain of Custody | TUVDC-COC-888330 · FSC licence FSC-C207236 | DIN CERTCO | → 2029-09-18 |
China Medical Device Filing
Class I Medical Device Filing 粤湛械备 20200001 号 — medical rubber examination gloves (non-sterile, single use; type 1 natural latex / type 2 nitrile), Zhanjiang Municipal Market Supervision Administration.
Independent Testing
TÜV SÜD REACH SVHC — PASS (report 7216010276, 2025-12-02, all 251 SVHC on the ECHA candidate list to 2025-11-05) · ASTM D6319 / ASTM D6978 (SGS) · EN 455-1/-2/-3 (TÜV) · EN ISO 374-1 · EN 420 (CTC).
Continuously certified. Consistently quality.
Third-party records. Most independent documentation about this factory is published in Chinese. Our government and industry recognition page translates the specific passages from the Zhanjiang Mazhang district government notices, the China Rubber Industry Association Latex Branch records and the Zhanjiang Daily reporting, with dates and links to the originals so they can be checked at source.
Records published by third parties. A separate page collects the nine public records we consider strongest and least flattering-to-ourselves to paraphrase — the national standard we helped draft, the 2025 Economic Daily case study, our FSC certificate in two registries, the empty FDA adverse-event and recall files, and the 2021 customs seizure in which our own mark was the one being counterfeited. Each entry carries the source’s date and a link to the original: independent verification records.