(88 days)
A 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.
Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile meet all requirements of ASTM standard D6319 and FDA 21 CFR 880.6250. The powder free nitrile examination glove is manufactured from synthetic rubber latex. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e., can be worn on right hand or left hand.
This document is a 510(k) premarket notification for a disposable patient examination glove. This type of device does not typically involve AI components or complex clinical studies for its clearance. Therefore, a significant portion of the requested information, particularly regarding AI development, ground truth establishment, expert consensus, and MRMC studies, is not applicable to this document.
Here's the information that can be extracted from the provided text, aligning with the categories requested:
1. Table of Acceptance Criteria and Reported Device Performance:
| CHARACTERISTICS | STANDARDS | Acceptance Criteria (from Standards) | Device Performance | Comparison Analysis |
|---|---|---|---|---|
| Physical Properties | ||||
| Before Aging | ASTM D6319, | Tensile Strength: Min 14.0 MPa | Tensile Strength: 32.35 MPa | Different but within the ASTM standard |
| Tensile Strength | ASTM D412 | Ultimate Elongation: Min 500% | Ultimate Elongation: 568% | Different but within the ASTM standard |
| After Aging | ASTM D6319, | Tensile Strength: Min 14.0 MPa | Tensile Strength: 36.10 MPa | Different but within the ASTM standard |
| Tensile Strength | ASTM D412 | Ultimate Elongation: Min 400% | Ultimate Elongation: 551% | Different but within the ASTM standard |
| Thickness | ASTM D6319, | Finger: min 0.05mm | Finger: 0.10 mm | Different but within the ASTM standard |
| ASTM D3767 | Palm: min 0.05mm | Palm: 0.07 mm | Different but within the ASTM standard | |
| Powder Free | ASTM D6124 | Less than 2 mg per glove | 0.24 mg/glove | Different but within the ASTM standard |
| Biocompatibility | ||||
| Primary Skin Irritation | ISO 10993-10:2010 | Not an irritant | 'Negligible' irritant response | Similar (both found not an irritant) |
| Dermal Sensitization | ISO 10993-10:2010 | Not a sensitizer | No skin sensitization effect | Similar (both found not a sensitizer) |
| Cytotoxicity | ISO 10993-5:2009 | Not cytotoxic (initial) | Cytotoxic effect (further tested) | Similar (both initially cytotoxic, clarified by AT) |
| Acute Systemic Toxicity | ISO 10993-11:2017 | No systemic toxicity concern | No systemic toxicity | Similar (both found no systemic toxicity concern) |
| Watertight | ASTM D5151:2019 | AQL 1.5, Acceptance No. 10 (for 315 pcs sample size) | 1 piece found with leaks (within AQL 1.5) | Same (both passed AQL 1.5) |
| Dimensions | ASTM D3767 | Length: Min 240 mm | Length: 248-250 mm | Pass |
| (for all sizes) | Width: e.g., 70 +/- 10 mm (X-Small) | Width: e.g., 78.0 mm (X-Small) | Pass |
Note: For characteristics like dimensions and biocompatibility, the provided text often states "Similar" or "Same" without explicitly detailing identical acceptance criteria across both tables presented, but it's implied that the new device meets the same underlying standards as the predicate.
2. Sample size used for the test set and the data provenance:
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Physical Properties: The sample size for physical properties testing (tensile strength, elongation) is not explicitly stated numerically, but the tests were performed "Before Aging" and "After Aging" according to ASTM D412.
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Watertight Test:
- Sample Size: 315 pieces (referencing a single sampling plan G1 for a batch size of 150,001 to 500,000, with AQL 1.5).
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Residual Powder:
- Sample Size: 5 pieces
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Biocompatibility Tests: Sample sizes for these tests (e.g., number of animals for irritation/sensitization, cells for cytotoxicity) are not specified in this document but are part of the respective ISO standards.
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Data Provenance: The testing was conducted by Onetexx Sdn Bhd, a manufacturer based in Kamunting, Perak, Darul Ridzuan, Malaysia. The data is prospective, generated specifically for this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This device is a medical glove, and its performance is evaluated against established physical, chemical, and biological standards (ASTM and ISO), not through expert interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. The evaluation relies on standardized test methods with objective measurements, not subjective interpretation requiring adjudication.
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 device is a medical glove, it does not involve AI or human "readers" in the context of diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device does not have an algorithm or AI component.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device is defined by the objective thresholds and methodologies specified in internationally recognized standards (ASTM D6319, ASTM D412, ASTM D3767, ASTM D6124, ASTM D5151, ISO 10993 series). These standards outline accepted levels of performance for physical properties, dimensions, watertightness, residual powder, and biocompatibility.
8. The sample size for the training set:
Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established:
Not applicable. This device does not involve a 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.