Search Results

This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

Device Description

Class I latex patient examination glove, 80LYY, powder free And meeting all the requirements of ASTM D-3578-01aE2, Standard Specification for Latex Examination Gloves for Medical Application.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the SGMP Company Ltd. latex examination gloves, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test/Parameter	Acceptance Criteria (ASTM D3578-01aE2 or FDA Internal)	Reported Device Performance (SGMP)
Dimensions	X-Small (width)	70 mm +/- 10 mm	70 - 75 mm
	Small (width)	80 mm +/- 10 mm	80 - 85 mm
	Medium (width)	95 mm +/- 10 mm	90 - 97 mm
	Large (width)	111 mm +/- 10 mm	105 - 111 mm
	Length (all sizes)	230 mm minimum	242 mm
	Thickness - Finger	0.08 mm min	0.08 mm min
	Thickness - Palm	0.08 mm min	0.08 mm min
Physical Properties (Before Aging)	Tensile Strength	14.0 Mpa	22.0 - 30.2 Mpa (depending on size)
	Ultimate Elongation	700 %	800 - 900 % (depending on size)
Physical Properties (After Aging)	Tensile Strength	14.0 Mpa	24.6 - 28.3 Mpa (depending on size)
	Ultimate Elongation	500 %	800 - 830 % (depending on size)
Water Tight Test (Leakage)	Acceptable Quality Level (AQL)	2.5% AQL (implied from FDA pinhole requirements)	Within 2.5% AQL (1-4 leaks out of 500 total tested)
Biocompatibility	General Biocompatibility	Passed tests for examination gloves (specifics not listed)	Passed the tests for examination gloves
Residual Powder Content	Residual Powder Content	2 mg/glove max (FDA internal requirement)	Range: 0.5-0.9 mg/glove, Mean: 0.7 mg/glove
	Presence of Cornstarch	Negative	Negative
Residual Protein Level	Latex Protein Level (ASTM D 5712-99)

Ask a Question

Ask a specific question about this device

Page 1 of 1