FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The gloves are intended to be worn on the hand of healthcare personnel, operating room personnel and similar personnel to prevent contamination between the healthcare or similar personnel to provent containmation between environment environment.

Device Description

Class I latex patient examination glove 80 LYY, powder free, hypoallergenic, protein labeling content, that meets all of the requirements of ASTM standard D3578-91.

AI/ML Overview

The provided document describes the acceptance criteria and performance data for "COMFIT POWDER FREE LATEX EXAMINATION GLOVES (HYPOALLERGENIC, UNBEADED, PROTEIN LABELING CONTENT)".

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

TEST	Acceptance Criteria (ASTM D 3578-91)	Reported Device Performance (COMFIT Powder Free Latex Examination Gloves)
1. Watertight (1000 ml)	S-4, AQL 4.0	Pass based on AQL of 2.5
2. Length (mm)
Size XS	- (Not specified)	275
Size S	min 230	287
Size M	min 230	282
Size L	min 230	284
Size XL	- (Not specified)	275
3. Palm width (mm)
Size XS	- (Not specified)	79
Size S	80 ± 10	83
Size M	95 ± 10	93
Size L	111 ± 10	103
Size XL	- (Not specified)	110
4. Thickness (mm)
Finger	min 0.08	0.25
Palm	min 0.08	0.22
5. Physical Properties Before Ageing:
Tensile Strength (MPa)	min 21	30.0
Ultimate Elongation (%)	min 700	806
Physical Properties After Ageing:
Tensile Strength (MPa)	min 16	28.1
Ultimate Elongation (%)	min 500	801
6. Powder Content	- (Not specified)	below 2 mg / glove
7. Protein Content	- (Not specified)	below 50 microgram / gram
Clinical Performance (Hypoallergenic Claim)	- (Not specified in table)	No potential for eliciting dermal irritation or sensitization
Pinhole FDA requirements	FDA requirements	Met

2. Sample size used for the test set and the data provenance

Physical Performance Data (ASTM D 3578-91 and FDA 1000 ml watertight test): The sample sizes for each specific test (e.g., watertight, length, width, thickness, physical properties) are not explicitly stated in the provided document. The document only states "Performance data of gloves to ASTM D 3578-91 and FDA 1000 ml watertight test."
Clinical Performance Data (Hypoallergenic): 200 Human subjects were used for the Modified Draize test.
Data Provenance: The document is a K953590 summary, indicating it's a regulatory submission. The company is Wembley Rubber Products, located in Malaysia. It does not explicitly state if the studies were retrospective or prospective, but clinical trials are typically prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

For Physical Performance Tests: The ground truth is established by the specified ASTM and FDA standards. These are standardized tests and do not typically involve experts establishing "ground truth" in the same way as an image interpretation study. The results are quantitative measurements against defined criteria.
For Clinical Performance Data (Hypoallergenic): The Modified Draize test protocol, a standard for assessing skin irritation and sensitization, is the basis. It typically involves a trained clinical professional to conduct and assess the results. The document does not specify the number or qualifications of experts directly involved in establishing the ground truth for the 200 human subjects.

4. Adjudication method for the test set

For Physical and Clinical Performance Tests: Adjudication methods like 2+1 or 3+1 are typically used in subjective assessments, such as radiology interpretations, where multiple readers might disagree. For objective physical and chemical tests, the results are quantitative and directly measured against a standard, so such adjudication is generally not applicable. For the Modified Draize test, the assessment of dermal irritation/sensitization follows a standardized scoring system. The document does not mention any adjudication method for these tests.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This type of study (MRMC for AI assistance) is not applicable to an examination glove, which is a physical medical device, not an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. This question is also not applicable as the device is a physical examination glove, not an algorithm or AI system.

7. The type of ground truth used

For Physical Performance: The ground truth is established by the requirements of reference standards, specifically ASTM D 3578-91 and FDA 1000 ml watertight test (which implies physical measurement and adherence to regulatory limits).
For Chemical Content (Powder and Protein): Quantitative laboratory measurements (e.g., below 2 mg/glove for powder, below 50 microgram/gram for protein using ASTM D5712).
For Clinical Performance (Hypoallergenic): The ground truth is established by the results of a Modified Draize Test on human subjects, which assesses dermal irritation and sensitization potential based on standardized observations.

8. The sample size for the training set

Not applicable. This device is a physical medical device. There is no "training set" in the context of an AI algorithm learning from data. The manufacturing process is subject to quality control and testing against standards.

9. How the ground truth for the training set was established

Not applicable. As there is no training set, this question is not relevant.

Summary

Regulation Number and Section

§ 880.6250 Non-powdered patient examination glove.

(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.