Quality & Testing

Lydus Examination Gloves meets or exceeds ASTM D6319 - Standard Specification for Nitrile Examination Glove for Medical Applications.

Meets or exceeds ISO 9001 and ISO 13485.

Standard

Lydus Examination Glovesmeets or exceed the following standards.

ASTM D6319

Standard Specification for Nitrile Examination Gloves for Medical Application

ASTM D6319
Clauses 6.1.2 & 7.3

Freedom from Holes (Cross-reference to Test Method D5151)

ASTM D6319
Clauses 6.1.3 & 7.4

Physical Dimensions Test

ASTM D6319
Clauses 6.1.4 & 7.5

Physical Requirements Test - Die C, accelerated aging conducted according to Clause 7.5.2.1: temperature of 70+2oC for 166+2h

ASTM D6319
Clauses 6.1.5 & 7.6

Power-free Residue (Cross-reference to Test Method D6124)

ASTM D6910

Material of Use: NItrile Compound

EN 374

Modified standard for chemical protective gloves

EN 420

General requirements and test methods for Protective Gloves

EN 455

General requirements and test methods for the physical properties of medical disposable gloves

EN 455-1
Part 1

Requirements and testing of gloves for freedom from holes

EN 455-2
Part 2

Requirements and tests for physical properties

EN 455-3
Part 3

Requirements and tests for biological evaluation

EN 455-4
Part 4

Requirements and testing for shelf life determination

ISO 10993-5
Part 5

Biological evaluation of medical devices — Tests for in vitro cytotoxicity

ISO 10993-10
Part 10

Biological evaluation of medical devices — Tests for irritation and skin sensitization

ISO 10993-11
Part 11

Acute Systemic Toxicity Study

ISO 9001

Criteria for a Quality Management System

ISO 13485

Requirements for a Quality Management System

Certification

Lydus Examination Glovesmeets or exceed the following regulatory requirements.

FDA 501(k)

FDA 501k Approval: K203191 (LZA)

EU CE

EU safety, health and environmental protection requirements

Classification

Lydus Examination Glovesmeets or exceed the following regulatory requirements.

Class I (MDD 93/42/EEC)

EU Classification: Class I - generally regarded as low risk

Class I (FDA)

USA Classification, Class I - generally regarded as low risk

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