Surgical and patient examination gloves are essential protective and infection-control supplies in Taiwan. Procurement, market authorization and quality audits should connect product classification, powder-free specifications and supply-chain evidence.
Regulations checked: October 28, 2026. Risk classification, market authorization and manufacturing quality requirements are separate decisions. A “sterile” or “medical-grade” label alone does not settle them.
1. Risk classification and glove categories
Taiwan's Medical Device Classification Regulations define Class I as low risk, Class II as medium risk and Class III as high risk. The annex identifies individual product categories. Regulations and current annex
Surgical gloves: I.4460
TFDA's identification criteria place natural or synthetic rubber gloves worn by operating-room personnel to prevent wound contamination, without glove lubricants or powder, in Class I. Gloves containing qualifying biodegradable, absorbable powder fall in Class II. Sterile surgical gloves therefore cannot all be described as Class II. Powdered products must also meet the separate manufacturing/import policy; a Class II entry does not itself authorize marketing. TFDA classification criteria
Patient examination gloves: J.6250
This category is used in examinations to prevent contamination between patient and examiner and is principally Class I. Check actual use, material, claims and the annex. A special coating or material alone does not automatically make a glove Class II. For new uses or combination products, assemble the manufacturer's instructions and classification rationale and consult TFDA when necessary. Classification Regulations
Class I does not always mean listing
Article 25 of Taiwan's Medical Devices Act generally requires registration and a license before manufacturing or import; only designated categories use listing. Check the applicable announcement before selecting a pathway rather than treating all Class I gloves as eligible for listing. Medical Devices Act
2. Regulatory and quality audit priorities
Powder-free policy: distinguish new production/imports from lawful existing stock
TFDA's FAQ states that the policy prohibiting manufacture and import of powdered medical gloves took effect on January 1, 2025. Unless powder-safety evidence is accepted by TFDA or another applicable exception applies, relevant licenses are generally revoked or expire from that date. Products lawfully manufactured or imported by December 31, 2024 may still circulate, be sold and used until their shelf life ends. The manufacturing/import prohibition is not an immediate ban on all existing stock. TFDA policy FAQ
For new procurement, match powder-free specifications, authorized product name and Chinese labeling with the product's residual-powder reports. I.4460 references EN ISO 21171, ASTM D6124 or equivalent standards and a 2.0 mg/glove specification; confirm the applicable version and sampling/acceptance method. Surgical gloves also require water-tightness and tensile-strength evidence under ISO 10282, ASTM D3577, EN 455 or equivalent standards. TFDA performance criteria
Market authorization, labeling and lot traceability
Verify the license or applicable listing status, approved use, model, material, manufacturer and physical stock. Link packaging, Chinese labeling, lot and expiry. Product licenses normally do not list every lot number: traceability instead connects manufacturing, import, release and receiving records.
QMS, ISO 13485 and manufacturing authorization
Article 22 requires manufacturers to establish a QMS and obtain manufacturing authorization where applicable; announced exemptions have their own conditions. Class I does not eliminate quality-system obligations, and ISO 13485 certification does not replace TFDA authorization. Check the current validity and scope of older GMP documents. Medical Devices Act
Review raw materials, processes, suppliers and complaints. For sterile products, examine sterilization validation, lot release, package integrity and shelf-life evidence. Importers should verify the applicable approval of the overseas manufacturer's quality system and control storage and distribution according to their role.
Supplier evaluation and incoming quality control (IQC)
Maintain an approved vendor list (AVL), verify medical-device business qualifications, source of supply and applicable QMS documents. Set reevaluation and audit frequency by risk. Receiving checks should cover specifications, labeling, expiry and packaging, with testing under product requirements and sampling plans. Storage follows authorized labeling and manufacturer instructions.
3. Regulatory and quality audit checklist
Adapt this worksheet to the product and organizational role. Y = conforms, N = does not conform, NA = not applicable. Record reasons for NA and retain evidence for every conclusion.
| Audit item | Review criteria | Y / N / NA | Notes and objective evidence |
|---|---|---|---|
| Classification and authorization | Document I.4460/J.6250 rationale; verify applicable license/listing, validity, model, material and manufacturer; connect stock through lot records. | □ Y □ N □ NA | Rationale: ___; authorization: ___; sampled lot: ___ |
| Powder-free policy | Match procurement specification, approved name and labeling; review powder, water-tightness and tensile evidence; verify lawful manufacture/import date and expiry of old powdered stock. | □ Y □ N □ NA | Test report: ___; label version: ___; stock-date evidence: ___ |
| Supplier evaluation (AVL) | Verify business qualification and applicable manufacturing/QMS scope; use ISO 13485 as supporting evidence; apply risk-based reevaluation, audits and change notification. | □ Y □ N □ NA | AVL ID: ___; qualification: ___; evaluation date: ___ |
| Receiving and storage | Check lot, expiry, appearance, package and labeling; review sterile-product release and validation; control storage, first-expiry-first-out and nonconforming-stock segregation. | □ Y □ N □ NA | IQC record: ___; sterile release: ___; storage log: ___ |
| CAPA, complaints and recall | Investigate damage, allergy and labeling issues; assess reportability and recall under applicable rules; verify CAPA effectiveness, lot traceability and recall exercises. | □ Y □ N □ NA | Procedure: ___; complaint/CAPA ID: ___; exercise record: ___ |
4. Conclusion
Start with correct classification and authorization, then connect powder-free performance, QMS, suppliers and lot evidence. Avoid replacing regulatory assessment with “sterile means Class II” or “Class I means listing.” This helps procurement and audits support patient safety.