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The Polyisoprene Surgical Gloves are single use device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. It is provided sterile.

Device Description

Polyisoprene Surgical gloves

AI/ML Overview

I am sorry, but the provided text from the FDA document (K240790) pertains to the clearance of "Polyisoprene Surgical gloves" and focuses entirely on regulatory information, such as:

The FDA's decision regarding the 510(k) premarket notification.
Classification of the device (Class I, reserved).
Applicable regulations (e.g., 21 CFR 878.4460 for Non-Powdered Surgeon's Glove, Quality System regulation 21 CFR Part 820).
Guidance on changes requiring new premarket notifications.
Information on adverse event reporting and other regulatory compliance.
The "Indications for Use" for the surgical gloves.

This document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any details related to AI/algorithm-based medical devices. It is a regulatory clearance letter for a non-software/AI medical device.

Therefore, I cannot provide the requested information regarding acceptance criteria and study details based on the provided text.

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K Number

K222620

Device Name

Sterilized Latex Surgical Gloves

Manufacturer

Suzhou Colour-way New Material Co., Ltd.

Date Cleared

2023-03-23

(205 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K212596

Intended Use

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 )	To determine the bacterial endotoxin of each sample meet the requirement of endotoxin limit	, ASTM D7160-16). These standards define the acceptable quantitative or qualitative outcomes for each test.