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The Sterilized Latex Surgical Glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

Device Description

The proposed sterilized latex surgical gloves are powder-free, sterile, single use, surgical gloves intended to be worn by operating room personnel to protect a surgical wound from contamination. The gloves are natural color (no colorant added). The gloves are offered in sizes of 6.5, 7, 7.5, 8, 8.5, 9. The gloves are designed and manufactured in accordance with the ASTM D3577-19 standard.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: Sterilized Latex Surgical Gloves (Suzhou Colour-way New Material Co., Ltd.)
Predicate Device: Sterile Latex Surgical Gloves Power Free (Amazing Rubber Products Pvt. Ltd.)

1. Table of Acceptance Criteria and Reported Device Performance

Test Methodology	Purpose	Acceptance Criteria	Reported Device Performance
Dimension (ASTM D3577-09)	To determine the length of the gloves	265mm, min	Pass. 6.5: 272-278mm; 7.0: 274-279mm; 7.5: 276-283mm; 8.0: 278-284mm; 8.5: 279-287mm; 9.0: 282-288mm
	To determine the width of the gloves	Size 6.5: 83 ± 6 mm	Pass. 6.5: 84-85mm
		Size 7: 89 ± 6 mm	Pass. 7.0: 90-92mm
		Size 7.5: 95 ± 6 mm	Pass. 7.5: 95-97mm
		Size 8: 102 ± 6 mm	Pass. 8.0: 103-105mm
		Size 8.5: 108 ± 6 mm	Pass. 8.5: 108-110mm
		Size 9: 114 ± 6 mm	Pass. 9.0: 114-116mm
	To determine the thickness of the gloves	Palm: 0.10 min; Finger: 0.10 min; Cuff: 0.10 min	Pass. Cuff: 0.14-0.16mm; Palm: 0.18-0.21mm; Finger: 0.22-0.25mm
Physical Property (ASTM D3577-09): Tensile Strength	To determine the physical property of tensile strength of the gloves	Before Aging: 24Mpa min for all sizes	Pass. Before Aging: 26.9-29.3MPa for all sizes
		After Aging: 18Mpa min for all sizes	Pass. After Aging: 21-26.3MPa for all sizes
Physical Property (ASTM D3577-09): Ultimate Elongation	To determine the physical property of ultimate elongation of the gloves	Before Aging: 750% min for all sizes	Pass. Before Aging: 800%-950% for all sizes
		After Aging: 560% min for all sizes	Pass. After Aging: 650%-790% for all sizes
Physical Property (ASTM D3577-09): Stress at 500%	To determine the physical properties of stress at 500% elongation of the gloves	Before Aging: 5.5Mpa, max for all sizes	Pass. Before Aging: 3.3-4.9MPa
Watertight Test (ASTM D5151-19)	To determine the watertightness of the gloves	AQL 1.5	Pass. No glove appears leakage for the size of 750 gloves have been tested.
Residual Power (ASTM D6124-06 (17))	To determine the residual power in the gloves	2mg per glove or less	Pass. 1.2-1.5mg/glove for all tested gloves
Aqueous Soluble Protein Content (ASTM D5712-15)	To determine the aqueous soluble protein content in the gloves	200 µg/dm² max for all sizes	Pass. 93.6-125.1 ug/dm² for all tested gloves
Irritation (ISO 10993-10)	To evaluate the potential skin irritation caused by test article contact with the skin surface of rabbits	Negligibly irritating	Pass. Under the condition of this study, the device is negligibly irritating.
Sensitization (ISO 10993-10)	The test was designed to evaluate the potential of a test article to cause skin sensitization	Non-sensitizing	Pass. Under the conditions of the study, the device is non-sensitizing
Systemic Toxicity (ISO 10993-11)	The test article was evaluated to determine whether leachables extracted from the test article would cause acute systemic toxicity following injection into mice	Non-systemic toxicity	Pass. Under the conditions of the study, there is no mortality or evidence of systemic toxicity from the extracts.
Pyrogen (ISO 10993-11)	The test article was evaluated for the risks of febrile reaction in the rabbit to the administration by injection	Non-pyrogenic	Pass. Under the conditions of the study, the test articles would not be considered be febrile reaction.
Bacterial Endotoxin (USP 43 <161>)	To determine the bacterial endotoxin of each sample meet the requirement of endotoxin limit	<20EU/pair of gloves	Pass. Under the conditions of the test, the bacterial endotoxin of each test article was less than 20 EU/pair.
Shelf Life (ASTM D7160-16)	To validate the shelf life of the proposed device	Three years	Pass. Accelerated aging validation were carried out. 13 samples for each lot have already been picked for real-time stability testing at 6th and 9th month of storage. Performance and package before and after aging were acceptable and met the requirements.

2. Sample Size Used for the Test Set and Data Provenance

Watertight Test (ASTM D5151-19): "750 gloves have been tested."
Irritation (ISO 10993-10): "contact with the skin surface of rabbits." (Specific number not provided, but implies animal testing)
Systemic toxicity (ISO 10993-11): "following injection into mice." (Specific number not provided, but implies animal testing)
Pyrogen (ISO 10993-11): "febrile reaction in the rabbit" (Specific number not provided, but implies animal testing)
Shelf Life (ASTM D7160-16): "13 samples for each lot have already been picked for real-time stability testing". The number of lots is not specified.
Other mechanical and chemical tests (dimensions, tensile strength, elongation, stress, residual power, aqueous soluble protein content, bacterial endotoxin): Sample sizes are not explicitly stated for these tests in the provided document, beyond the general statement that tests were "conducted to adequately demonstrate the effectiveness of the device."
Data Provenance: The document does not explicitly state the country of origin for the test data. However, the applicant is "Suzhou Colour-way New Material Co., Ltd." in CHINA, and the submission correspondent is in Shanghai, China. The tests are non-clinical (laboratory/animal-based) rather than human clinical trials. All experiments appear to be prospective, laboratory tests conducted specifically for this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This document describes technical and biological performance testing (non-clinical) of a medical device (surgical gloves). It does not involve human expert consensus for a "ground truth" in the way a diagnostic AI study would. The acceptance criteria are based on established international standards (ASTM, ISO, USP). The "ground truth" for these tests is the objective measurement against these published standards.

4. Adjudication Method for the Test Set

Not applicable. This is not a study that involves human readers or an adjudication process for subjective interpretation of data. The tests are objective measurements against defined standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is typically for evaluating the effectiveness of a diagnostic tool, often an AI algorithm, by comparing human readers' performance with and without AI assistance. This document is for a physical medical device (surgical gloves) and involves non-clinical performance and biocompatibility testing.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No. This is not an AI algorithm. It is a physical medical device.

7. The Type of Ground Truth Used

The ground truth used for all tests is based on established international standards and specifications (ASTM D3577-19, ASTM D5151-19, ASTM D6124-06 (Reapproved 2017), ASTM D5712-2015, ISO 10993-05, ISO 10993-10, ISO 10993-11, USP 43 <161>, ASTM D7160-16). These standards define the acceptable quantitative or qualitative outcomes for each test.

8. The Sample Size for the Training Set

Not applicable. This is not an AI algorithm study; therefore, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for an AI algorithm, there is no ground truth established for it.

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