K Number
K212751
Date Cleared
2022-09-24

(390 days)

Product Code
Regulation Number
880.6250
Panel
HO
Reference & Predicate Devices
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Blue Nitrile Examination Gloves Powder Free are disposable devices intended for medical purpose that are worn on the examiner's hand to prevent contamination between patient and examiner.

Device Description

Dainam JSC., Powder Free Gloves are Class I patient examination gloves bearing the product code Nitrile - LZA (21CFR880.6250). The gloves are made from acrylonitrile- butadiene copolymer dispersion. These gloves are blue in color and are powder free, non-sterile, single use and disposable and available in size XS-extra small, S-small, M-medium, L-Large, XL- Extra-large.

AI/ML Overview

This document is a 510(k) Pre-Market Notification from the FDA for a medical device (Powder Free Nitrile Examination Glove). It details the device's characteristics, intended use, and a comparison to a predicate device, along with non-clinical testing results.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

Test Method (Standard)PurposeAcceptance CriteriaReported Device Performance (Result)
ASTM D6319-2019Determine glove lengthMin 230 mm for all sizesX-Small: +/-240 mm, Small: +/-240 mm, Medium: +/-240 mm, Large: +/-240 mm, X-Large: +/-240 mm (All meet or exceed 230 mm)
ASTM D6319-2019Determine glove widthX-Small: 70+/-10 mm, Small: 80+/-10 mm, Medium: 95+/-10mm, Large: 110+/-10mm, X-Large: 120+/-10 mmX-Small: 70+/-10 mm, Small: 80+/-10 mm, Medium: 95+/-10mm, Large: 110+/-10 mm, X-Large: 120+/-10 mm (All meet criteria)
ASTM D6319-2019Determine glove thicknessPalm 0.05 mm min, Finger 0.05 mm min for all sizesX-Small Palm: 0.07mm Finger: 0.10mm, Small Palm: 0.07mm Finger: 0.9mm, Medium Palm: 0.07mm Finger: 0.9mm, Large Palm: 0.07mm Finger: 0.8mm, X-Large Palm: 0.07mm Finger: 0.7mm (All meet or exceed criteria)
ASTM D6319-2019Determine physical properties - Tensile strength (Before Aging)Before Ageing Tensile Strength 14Mpa Min for all sizesX-Small: 27Mpa, Small: 26Mpa, Medium: 25Mpa, Large: 33Mpa, X-Large: 32Mpa (All meet or exceed 14 Mpa)
ASTM D6319-2019Determine physical properties - Tensile strength (After Aging)After Ageing Tensile Strength 14Mpa Min for all sizesX-Small: 25Mpa, Small: 26Mpa, Medium: 27Mpa, Large: 36Mpa, X-Large: 33Mpa (All meet or exceed 14 Mpa)
ASTM D6319-2019Determine physical properties - Ultimate Elongation (Before Aging)Before Ageing Ultimate Elongation 500% Min for all sizesX-Small: 520%, Small: 567%, Medium: 553%, Large: 568%, X-Large: 539% (All meet or exceed 500%)
ASTM D6319-2019Determine physical properties - Ultimate Elongation (After Aging)After Ageing Ultimate Elongation 400% Min for all sizesX-Small: 509%, Small: 545%, Medium: 538%, Large: 560%, X-Large: 570% (All meet or exceed 400%)
ASTM D5151-2019Determine holes in the glovesAQL 2.5Gloves Passes AQL 2.5
ASTM D6124-06 (Reapproved 2017)Determine residual powder in the gloves2 Mg/Glove MaxX-small: 0.3mg/glove, Small: 1.4mg/glove, Medium: 2 mg/glove, Large: 0.5 mg/glove, X-Large: 0.7mg/glove (All meet or are below 2 Mg/Glove)
ISO 10993-10 (Irritation)Determine potential for dermal irritation in RabbitsUnder the condition of study not an irritantUnder the condition of study not an irritant
ISO 10993-10 (Sensitization)Determine skin sensitization potential in Guinea PigUnder the conditions of the study not a sensitizerUnder the conditions of the study not a sensitizer
ISO 10993-5:2009 (In vitro cytotoxicity)Evaluate in vitro cytotoxic potentialUnder the conditions of study non cytotoxicUnder the conditions of the study cytotoxic (This is an interesting result, as it states "cytotoxic" where the acceptance criteria states "non cytotoxic". This typically requires additional justification or risk assessment for FDA clearance.)
ISO 10993-11:2017 (Acute systemic toxicity)Determine acute systemic toxicity potential in miceUnder the conditions of study, the device extracts do not pose a systemic toxicity concernUnder the conditions of study the device extracts do not pose a systemic toxicity concern
ISO 10993-11:2017 (Material Mediated Pyrogenicity)Determine pyrogenic potential in RabbitsUnder the conditions of the study, the device did not demonstrate a material mediated pyrogenicity responseUnder the conditions of the study, the device did not demonstrate a material mediated pyrogenicity response

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document lists test methods (e.g., ASTM D6319-2019, ISO 10993 series) but does not specify the sample sizes used for each test for the subject device. It also does not specify the data provenance in terms of country of origin or whether the tests were retrospective or prospective. It only indicates that "Non-clinical tests were conducted to verify that the proposed device complies with the following standards".

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This product is a medical examination glove, which is a physical device, not an AI or diagnostic imaging product. Therefore, the concept of "experts" establishing a "ground truth" for a test set in the way it's described (e.g., radiologists for medical images) does not apply to this type of device. Performance is measured against established material and safety standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The concept of an "adjudication method" (like 2+1 or 3+1 consensus) is relevant for studies involving human interpretation of data, particularly in diagnostics or AI algorithm validation. Since this document pertains to the physical and biocompatibility testing of a medical glove, this method is not applicable and not mentioned.

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

This is a physical medical device (examination glove), not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study is not applicable and was not performed.

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

Again, this is a physical medical device. The concept of "standalone algorithm performance" does not apply. The tests performed are on the physical and chemical properties of the glove itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For this type of device, "ground truth" is defined by the established ASTM and ISO standards for physical properties (like length, width, thickness, tensile strength, elongation, watertightness, powder residue) and biocompatibility (irritation, sensitization, cytotoxicity, systemic toxicity, pyrogenicity). These standards themselves represent a consensus on what constitutes acceptable performance for such a device.

8. The sample size for the training set

This is a physical medical device, not an AI algorithm. Therefore, the concept of a "training set" for machine learning does not apply and no training set was used.

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

As there is no training set for this type of device, this question is not applicable.

§ 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.