(94 days)
ComfortPro Blue Nitrile Examination Gloves Powder free is disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
ComfortPro Blue Nitrile Examination Gloves Powder Free is Class I patient examination gloves bearing the product code LZA (21CFR880.6250). The gloves are made from Nitrile (NBR)100%. These gloves are blue in color, non-sterile, ambidextrous, powder free and single use only. Blue Nitrile Examination Gloves Powder Free are available in sizes X-small, Small, Medium, Large and X Large.
The provided document is a 510(k) summary for the ComfortPro Blue Nitrile Examination Gloves Powder Free. It describes the device, its intended use, and a comparison to a predicate device based on non-clinical performance data.
Here's the breakdown of the acceptance criteria and study information as requested:
1. A table of acceptance criteria and the reported device performance
| Test Method | Purpose | Acceptance Criteria (Predicate / Standard) | Reported Device Performance (Subject Device) |
|---|---|---|---|
| Bench Test Data | |||
| ASTM D6319-19 (Length) | To determine the length of the gloves | Min 230 mm for all sizes | X-Small: 250mm, Small: 241mm, Medium: 245mm, Large: 242mm, X-Large: 242mm |
| ASTM D6319-19 (Width) | To determine the width of the gloves | X-Small: 70+/-10 mm, Small: 80+/-10mm, Medium: 95+/-10 mm, Large: 110+/-10 mm, X Large: 120+/-10 mm | X-Small: 80 mm, Small: 82mm, Medium: 93mm, Large: 103mm, X-Large: 110mm |
| ASTM D6319-19 (Thickness) | To determine the thickness of the gloves | Palm: 0.05 mm min, Finger: 0.05 mm min (for all sizes) | Palm (mm): X-Small: 0.101, Small: 0.081, Medium: 0.091, Large: 0.092, X-Large: 0.091 |
| Finger (mm): X-Small: 0.121, Small: 0.097, Medium: 0.108, Large: 0.108, X-Large: 0.111 | |||
| ASTM D6319-19 (Tensile Strength) | To Determine the physical properties - Tensile strength | Before Ageing: Tensile Strength 14 Mpa Min for all sizes | |
| After Ageing: Tensile Strength 14 Mpa Min for all sizes | Before Ageing (Mpa): X-Small: 27.2, Small: 23.2, Medium: 24, Large: 26.2, X-Large: 27.4 | ||
| After Ageing (Mpa): X-Small: 24.2, Small: 23.8, Medium: 27.6, Large: 27.6, X-Large: 27.9 | |||
| ASTM D6319-19 (Ultimate Elongation) | To Determine the physical properties - Ultimate Elongation | Before Ageing: Ultimate Elongation 500% Min for all sizes | |
| After Ageing: Ultimate Elongation 400% Min for all sizes | Before Ageing (%): X-Small: 620, Small: 590, Medium: 570, Large: 570, X-Large: 550 | ||
| After Ageing (%): X-Small: 600, Small: 560, Medium: 540, Large: 540, X-Large: 550 | |||
| ASTM D5151-19 (Water Tight) | To determine the holes in the gloves | AQL 2.5 | Gloves Passes AQL 2.5 |
| ASTM D6124-06 (Residual Powder) | To determine the residual powder in the gloves | ≤2 Mg/Glove | 0.49 mg/glove |
| Biocompatibility Data | |||
| ISO 10993-10:2010 (Primary Skin Irritation) | To evaluate the test item, for skin irritation test in New Zealand White rabbits. | Under the condition of study not an irritant | Under the condition of study, not an irritant |
| ISO 10993-10:2010 (Dermal Sensitization) | To evaluate the test item, for the Skin Sensitization in Guinea pigs by maximization test. | Under the conditions of the study, not a sensitizer | Under the conditions of the study, not a sensitizer |
| ISO10993-5:2009 (In vitro cytotoxicity) | To evaluate the test item, for its ability to induce cytotoxicity using L-929 mouse fibroblast cells by Elution Method. | Under the conditions of the study, non-cytotoxic | Under the conditions of the study cytotoxic for 100% test item extract and non-cytotoxic at 50%, 25%, 12.5% and 6.25% test item extracts. Moreover, under the conditions of the study, non acute systemic toxic. |
| ISO 10993-11:2017 (Acute Systemic Toxicity Test) | To evaluate the test item, for Acute Systemic Toxicity in Swiss Albino Mice. | Under the conditions of study, the device extracts do not pose a systemic toxicity concern | Under the condition of study, the device extracts did not reveal any systemic toxicity. |
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 does not specify the exact sample sizes used for each test (e.g., how many gloves were tested for length, width, tensile strength, etc., or how many animals were used for biocompatibility tests). It only states they meet the relevant ASTM and ISO standards, which likely prescribe minimum sample sizes.
- Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given that the manufacturer is "THAI RUBBER INDUSTRY COMPANY LIMITED" in Thailand, it is highly probable the testing was conducted in Thailand or by contractors on behalf of the Thai manufacturer. The nature of these tests (bench testing for physical properties and biocompatibility for materials) suggests they are prospective tests conducted on representative samples of the manufactured device.
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 question is not applicable to this type of device (nitrile examination gloves) and the studies performed. The "ground truth" for these tests are objective, measurable physical and chemical properties and biological responses, determined by standardized test methods (ASTM, ISO), rather than expert interpretation or consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This question is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies, particularly those involving interpretation of medical images or patient outcomes where subjective expert opinion is involved. The tests for these gloves are objective measurements against predefined standards.
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 question is not applicable. MRMC studies are specific to medical imaging devices, often involving AI, to assess the impact of AI assistance on human reader performance. Examination gloves do not involve "readers" or "AI assistance" in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable. This concept applies to AI-driven algorithms. The ComfortPro Blue Nitrile Examination Gloves are physical medical devices.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" is established by the defined specifications and test methods within the ASTM and ISO standards. For example, the "ground truth" for length is "Min 230 mm," and the test result is a direct measurement. Similarly, for biocompatibility, the "ground truth" is "not an irritant" or "non-cytotoxic," determined by specific biological assays.
- It's a combination of objective measurements compared against pre-defined normative standards.
8. The sample size for the training set
- This question is not applicable. The device is not an AI/ML algorithm that requires a "training set." The performance data is derived from testing physical samples of the manufactured gloves.
9. How the ground truth for the training set was established
- This question is not applicable for the same reason as point 8.
§ 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.