Quality & Testing

Lydus Examination Gloves meet or exceed ASTM D6319 - Standard Specification for Nitrile Examination Gloves for Medical Application.

Meets or exceeds ISO 9001 and ISO 13485.

Standard

Lydus Examination Glovesmeet or exceed the following standards.

Certification

Lydus Examination Glovesmeet or exceed the following regulatory requirements.

	FDA 501(k) FDA 501k Approval: K203191 (LZA)	FDA 501k Approval: K203191 (LZA)
	EU CE EU safety, health and environmental protection requirements	EU safety, health and environmental protection requirements

Classification

Lydus Examination Glovesmeet or exceed the following regulatory requirements.

	Class I (MDD 93/42/EEC) EU Classification: Class I - generally regarded as low risk	EU Classification: Class I - generally regarded as low risk
	Class I (FDA) USA Classification, Class I - generally regarded as low risk	USA Classification, Class I - generally regarded as low risk

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	ASTM D6319 Standard Specification for Nitrile Examination Gloves for Medical Application	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)	Freedom from Holes (Cross-reference to Test Method D5151)
	ASTM D6319 Clauses 6.1.3 & 7.4 Physical Dimensions Test	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	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)	Power-free Residue (Cross-reference to Test Method D6124)
	ASTM D6910 Material of Use: NItrile Compound	Material of Use: NItrile Compound
	EN 374 Modified standard for chemical protective gloves	Modified standard for chemical protective gloves
	EN 420 General requirements and test methods for Protective Gloves	General requirements and test methods for Protective Gloves
	EN 455 General requirements and test methods for the physical properties of medical disposable gloves	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	Requirements and testing of gloves for freedom from holes
	EN 455-2 Part 2 Requirements and tests for physical properties	Requirements and tests for physical properties
	EN 455-3 Part 3 Requirements and tests for biological evaluation	Requirements and tests for biological evaluation
	EN 455-4 Part 4 Requirements and testing for shelf life determination	Requirements and testing for shelf life determination
	ISO 10993-5 Part 5 Biological evaluation of medical devices — Tests for in vitro cytotoxicity	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	Biological evaluation of medical devices — Tests for irritation and skin sensitization
	ISO 10993-11 Part 11 Acute Systemic Toxicity Study	Acute Systemic Toxicity Study
	ISO 9001 Criteria for a Quality Management System	Criteria for a Quality Management System
	ISO 13485 Requirements for a Quality Management System	Requirements for a Quality Management System