(112 days)
TMG nitrile powder free examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
TMG Nitrile Examination Gloves Powder Free 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.
Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
This document describes the premarket notification (510(k)) for the TMG Nitrile Powder Free Examination Glove, a Class I medical device. The submission aims to demonstrate substantial equivalence to a predicate device, K202384.
The "study" refers to non-clinical performance data testing, as clinical data was deemed not needed for this type of device.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Standard / Test Method | Acceptance Criteria | Device Performance (Reported Result) | Status |
|---|---|---|---|---|
| Dimension | ASTM D6319-19 | |||
| - Length | ASTM D6319-19 | Min 230 mm for all sizes | Small: 243 mm, Medium: 240 mm, Large: 240 mm, Extra Large: 240 mm | Pass |
| - Width | ASTM D6319-19 | Small: 80 ± 10 mm, Medium: 95 ± 10 mm, Large: 110 ± 10 mm, Extra Large: 120 ± 10 mm | Small: 85 mm, Medium: 93 mm, Large: 105 mm, Extra Large: 115 mm | Pass |
| - Thickness | ASTM D6319-19 | Palm 0.05 mm min, Finger 0.05 mm min for all sizes | Small: Palm 0.09 mm, Finger: 0.13 mm | |
| Medium: Palm: 0.06 mm, Finger: 0.08 mm | ||||
| Large: Palm 0.09 mm, Finger: 0.12 mm | ||||
| Extra Large: Palm 0.09 mm, Finger: 0.12 mm | Pass | |||
| Watertight test | ASTM D5151-19 | Sample size: 200 pcs, Inspection level: GI, AQL 1.5, Acceptance Number 7, Rejection Number 8 | Small: 0 (Zero), Medium: 0 (Zero), Large: 0 (Zero), Extra Large: 0 (Zero) | Pass |
| Residual Powder | ASTM D6124-06 (Reapproved 2017) | 2 mg per glove or less | Small: 1.42 mg/glove, Medium: 0.50 mg/glove, Large: 1.34 mg/glove, Extra Large: 1.36 mg/glove | Pass |
| Physical Properties | ASTM D6319-19 | |||
| - Tensile Strength | Before Ageing: 14 MPa min for all sizes | Before Ageing: | ||
| Small: 18.37 MPa, Medium: 30.62 MPa, Large: 18.30 MPa, Extra Large: 18.20 MPa | Pass | |||
| After Ageing: 14 MPa min for all sizes | After ageing: | |||
| Small: 14.08 MPa, Medium: 31.89 MPa, Large: 14.00 MPa, Extra Large: 14.00 MPa | Pass | |||
| - Ultimate Elongation | Before Ageing: 500% Min for all sizes | Before Ageing: | ||
| Small: 612%, Medium: 500 %, Large: 620%, Extra Large: 587% | Pass | |||
| After Ageing: 400% Min for all sizes | After ageing: | |||
| Small: 408%, Medium: 499%, Large: 403%, Extra Large: 416% | Pass | |||
| Biocompatibility | ISO 10993-10 (Primary Skin Irritation) | Not an irritant | Under the conditions of the study, not an irritant | Same (as predicate) |
| ISO 10993-10 (Dermal Sensitization) | Not a sensitizer | Under the conditions of the study, not a sensitizer | Same (as predicate) | |
| ISO10993-5:2009(E) (In vitro cytotoxicity) | Not cytotoxic | Cytotoxic for undiluted, 1:2 and 1:4 dilutions but noncytotoxic for 1:8, 1:16 and 1:32 dilutions. | Different (from predicate, further qualified as "non acute systemic toxic") | |
| ISO10993-11:2017(E) (Acute Systemic Toxicity) | No systemic toxicity concern | Under the conditions of the study, did not induce any systemic toxicity. | Same (as predicate) |
2. Sample Size Used for the Test Set and Data Provenance
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Dimension: Not explicitly stated for each dimension test, but implied to be sufficient for ASTM D6319-19 compliance. Each result listed (Small, Medium, Large, Extra Large) likely represents an average or single measurement for that size.
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Watertight Test: Sample size of 200 pieces per batch from a batch size of 35,001-150,000 gloves.
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Residual Powder: Sample size of 5 pieces (per size, assumed).
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Physical Properties (Tensile Strength, Ultimate Elongation): Not explicitly stated, but implied to be sufficient for ASTM D6319-19 compliance. Each result listed likely represents an average of multiple samples.
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Biocompatibility: Sample sizes for ISO 10993 tests are not specified for this report, but would be standard for such tests.
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Data Provenance: The data is from the manufacturer's testing (THAI MEDICAL GLOVE CO., LTD.) of their current device (TMG Nitrile Powder Free Examination Glove). This is prospective testing conducted to demonstrate equivalence for their new device. The country of origin is Thailand.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is a physical product (gloves) and the "ground truth" is established by adhering to recognized international and national consensus standards (e.g., ASTM, ISO) for physical and chemical properties, rather than expert interpretation of medical images or clinical outcomes. The tests are objective measurements.
4. Adjudication Method for the Test Set
Not applicable. The tests are objective measurements against predefined criteria in standards. There is no subjective assessment requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret results (e.g., radiologists reviewing images with or without AI assistance). This is a physical product where performance is measured objectively.
6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) was done
Yes, in a sense, a "standalone" performance evaluation was done. The performance of the glove itself was tested against the acceptance criteria, without human interaction influencing the fundamental measurement of its physical and chemical properties. This is an "algorithm only" equivalent in that the device's intrinsic properties are being evaluated.
7. The Type of Ground Truth Used
The ground truth used for performance evaluation is based on established industry and regulatory standards:
- ASTM D6319-19 (Standard Specification for Nitrile Examination Gloves for Medical Application)
- ASTM D5151-19 (Standard Test Method for Detection of Holes in Medical Gloves)
- ASTM D6124-06 (Reapproved 2017) (Standard Test Method for Residual Powder on Medical Gloves)
- ISO 10993-10 (Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization)
- ISO10993-5:2009(E) (Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity)
- ISO10993-11:2017(E) (Biological evaluation of medical devices – Part 11: Tests for systemic toxicity)
These standards define the methodologies and acceptable ranges for the glove's characteristics.
8. The Sample Size for the Training Set
Not applicable. This device does not use machine learning or AI, and therefore does not have a "training set" in the context of AI model development.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
§ 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.