(162 days)
Siam NTD+ NITRILE POWDER-FREE EXAMINATION GLOVES 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.
Siam NTD* NITRILE POWDER-FREE EXAMINATION GLOVES is a glove made from nitrile butadiene rubber Latex that covers the hand up to the wrist. It is cuffed and equally wearable on either hand, free from differentiation between the left hand and the right. It has 4 sizes, i.e. small, medium, large and extra large. All variations share the same blue color. The glove is non-sterile and is for single use only, to be discarded after each examination is performed. It acts as a barrier between the examiner and the subject being examined in order to prevent contamination between them.
The document describes the non-clinical performance data for the Siam NTD+ NITRILE POWDER-FREE EXAMINATION GLOVES.
Here's the information requested based on the provided text:
1. A table of acceptance criteria and the reported device performance:
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASMT D6319-19 (Dimensions) | To determine the width, length, and thickness of the gloves | Width: Small: $80\pm10$ mm, Medium: $95\pm10$ mm, Large: $110\pm10$ mm, X-Large: $120\pm10$ mm | |
| Length: Small: 220 mm, Medium: 230mm, Large: 230 mm, X-Large: 230 mm | |||
| Thickness: Finger: 0.05 mm min for all sizes, Palm: 0.05 mm min for all sizes | Width: Small: 84 mm, Medium: 95 mm, Large: 104 mm, X-Large: 114 mm | ||
| Length: Small: 247 mm, Medium: 248 mm, Large: 247 mm, X-Large: 248 mm | |||
| Thickness: Finger: Small: 0.11 mm, Medium: 0.10 mm, Large: 0.10 mm, X-Large: 0.10 mm; Palm: Small: 0.07 mm, Medium: 0.07 mm, Large: 0.07 mm, X-Large: 0.07 mm; Cuff: Small: 0.06 mm, Medium: 0.05 mm, Large: 0.05 mm, X-Large: 0.06 mm | |||
| ASMT D6319-19 (Physical Properties - Before Aging) | To determine the tensile strength and ultimate elongation | Tensile Strength Min 14 Mpa | |
| Ultimate Elongation Min 500% | Tensile Strength (Mpa): Small: 27.2, Medium: 27.6, Large: 26.6, X-Large: 27.8 | ||
| Ultimate Elongation (%): Small: 540, Medium: 575, Large: 580, X-Large: 561 | |||
| ASMT D6319-19 (Physical Properties - After Acceleration Aging) | To determine the tensile strength and ultimate elongation | Tensile Strength (MPa): 14 (Min) for all sizes | |
| Ultimate Elongation (%): 400 (Min) for all sizes | Tensile Strength: Small: 14.6 Mpa, Medium: 15.5 Mpa, Large: 15.4 Mpa, X-Large: 14.9 Mpa | ||
| Ultimate Elongation: Small: 413%, Medium: 424%, Large: 446%, X-Large: 442% | |||
| ASTM D6319-19 (ASTM D5151-11) (Freedom from Holes) | To determine the holes in the gloves | AQL 2.5 | Gloves Passed AQL 1.5 |
| ASMT D6319-19 (ASTM D6124-11) (Residual Powder) | To determine the residual powder in the gloves | ≤2.0 mg/glove | Small: 0.48 mg/glove, Medium: 0.35 mg/glove, Large: 0.38 mg/glove, X-Large: 0.18 mg/glove |
| ISO 10993-10 (Skin Irritation) | To determine the potential for skin irritation | Under the condition of study not an irritant | Under the condition of study not an irritant |
| ISO 10993-10 (Skin Sensitization) | To determine the skin sensitization potential | Under the conditions of the study not a sensitizer. | Under the conditions of the study not a sensitizer. |
| ISO 10993-5 (In Vitro Cytotoxicity) | To evaluate the in vitro cytotoxic potential | Under the conditions of study non cytotoxic | Under the conditions of the study, concentration of extract, 100%, 66%, 44%, 30%, 20% was cytotoxic., 13%, 9%, 6% are not cytotoxic |
| ISO 10993-11:2017 (Acute Systemic Toxicity) | To determine the acute systemic toxicity potential | Under the conditions of the study no systemic toxicity | Under the conditions of the study did not reveal any systemic toxicity. |
2. Sample size used for the test set and the data provenance:
- Sample size: The document does not explicitly state the sample size (number of gloves or individual test items) used for each specific test. It provides results per size (Small, Medium, Large, X-Large) for some tests, but not the 'n' for each.
- Data provenance: The tests were conducted to comply with international standards (ASTM and ISO). The manufacturing company is Siam NTD Corporation Co., Ltd. located in Pathum Thani, Thailand, and the manufacturing entity for the device is TOP GLOVE MEDICAL (THAILAND) CO., LTD. This suggests the tests were likely conducted in Thailand or by a laboratory recognized in Thailand. The data is retrospective, as it's submitted for a 510(k) clearance after the tests have been completed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is a technical performance test of a physical device (gloves) against established engineering and biocompatibility standards, not a diagnostic or interpretative AI device where expert ground truth is typically required. The "ground truth" here is defined by the technical specifications and methods of the ASTM and ISO standards.
4. Adjudication method for the test set:
- Not applicable. As noted above, this is not an interpretation task requiring adjudication. The results are quantitative measurements or qualitative assessments (e.g., "passed") against objective criteria.
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:
- Not applicable. This document pertains to the technical performance validation of a physical medical device (examination gloves), not an AI/ML-powered diagnostic tool. Clinical studies with human readers or AI assistance are not relevant to this type of device submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This document is for examination gloves, which do not involve algorithms or human-in-the-loop performance.
7. The type of ground truth used:
- Engineering and Biocompatibility Standards: The "ground truth" for the device's performance is defined by the acceptance criteria set forth in recognized international standards:
- ASTM D6319-19 (Standard Specification for Nitrile Examination Gloves for Medical Application)
- ASTM D5151-11 (Standard Test Method for Detection of Holes in Medical Gloves)
- ASTM D6124-11 (Standard Test Method for Residual Powder on Medical Gloves)
- ISO 10993-10 (Biological evaluation of medical devices - Tests for skin irritation and skin sensitization)
- ISO 10993-5 (Biological evaluation of medical devices - Tests for in vitro cytotoxicity)
- ISO 10993-11:2017 (Biological evaluation of medical devices - Tests for acute systemic toxicity)
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. There is no training set for this device.
§ 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.