(95 days)
The Disposable Nitrile Examination gloves are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.
The proposed device is Powder Free Disposable Nitrile Examination gloves. The proposed device is blue. The design of proposed device is addressing the standards as ASTM D6124,ASTM D5151, and ASTM D6319. The proposed device is non-sterile.
The provided document describes the acceptance criteria and performance data for Disposable Nitrile Examination Gloves. The study primarily focuses on non-clinical tests to demonstrate substantial equivalence to a predicate device.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method (Reference Standard) | Purpose | Acceptance Criteria | Reported Device Performance | Status |
|---|---|---|---|---|
| Watertight (ASTM D5151) | To detect holes that leak water and thereby compromise the usefulness of the glove. | Immediately inspect the glove visually for water leakage. Let the glove hang for 2 min and again inspect for water leakage. Batch size: 35000, Sample size: 125 pcs, Inspection level: I, AQL: 2.5, Ac=7, Re=8 | During the test, 0 piece was found with leaks. Hence it falls within the acceptance criteria. | Pass |
| Physical Properties (ASTM D412) | To evaluate the tensile (tension) properties of the glove. | Batch size: 35000, Inspection level: S-2, Sample size: 8 pcs, AQL: 4.0, Ac=1, Re=2. |
Before Aging: Tensile Strength ≥ 14MPa, Ultimate Elongation ≥ 500%
After Accelerated Aging: Tensile Strength ≥ 14MPa, Ultimate Elongation ≥ 400% | Before Aging (Average): Tensile Strength = 16.41MPa, Ultimate Elongation = 540.56%
After Accelerated Aging (Average): Tensile Strength = 16.41MPa, Ultimate Elongation = 532.98% (Note: Appears to be a typo/repetition in the document, as "After Accelerated Aging" results are identical to "Before Aging" average for Tensile Strength and very similar for Elongation, usually there's some degradation.) | Pass |
| Physical Dimensions (ASTM D3767-03(2014)) | To measure the length, width, and thickness of the glove. | Length: S: Min. 220 mm, M: Min. 230 mm, L: Min. 230 mm, XL: Min. 230 mm
Width: S: 80±10mm, M: 95±10mm, L: 110±10mm, XL: 120±10mm
Thickness: Finger: Min. 0.05 mm, Palm: Min. 0.05 mm | Length: S: Min. 243 mm, M: Min. 249 mm, L: Min. 251 mm, XL: Min. 271 mm (All exceed minimum)
Width: S: 86-89mm, M: 97-99mm, L: 106-109mm, XL: 110-120mm (All within tolerance)
Thickness: Finger: Min. 0.08 mm, Palm: Min. 0.08 mm (All exceed minimum) | Pass |
| Residual Powder (ASTM D6124) | To determine the amount of residual powder and non-powder solids found on gloves. | Less than 2 mg per glove. | Result: 0.04 (mg/glove) | Pass |
| Biocompatibility (ISO 10993-10, ISO 10993-5) | To assess irritation, sensitization, and cytotoxicity. | Irritation: Not an irritant
Sensitization: Not a sensitizer
Cytotoxicity: Did not show potential toxicity to L-929 cells | Under the conditions of the study, not an irritant and not a sensitizer. Did not show potential toxicity to L-929 cells. | Pass |
2. Sample size used for the test set and the data provenance
- Watertight (ASTM D5151): Sample size = 125 pcs (from a batch size of 35000)
- Physical Properties (ASTM D412): Sample size = 8 pcs (from a batch size of 35000)
- Residual Powder (ASTM D6124): Sample size = 5 pcs
- Biocompatibility: Specific sample sizes are not explicitly stated for individual tests but imply testing performed on the device material.
- Data Provenance: The document (K211264) is a 510(k) submission from Shenzhen Shiqiao Science and Technology Co. LTD, China. The testing was conducted as part of this premarket notification. The data is prospective for this submission, meaning it was gathered specifically to support this application.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the tests performed are objective, laboratory-based physical and chemical tests (e.g., measuring dimensions, tensile strength, presence of holes, powder content, biological reactions). They do not involve human interpretation of complex data like medical images or clinical outcomes that would require expert consensus for ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable for the type of objective tests performed on the gloves. Adjudication methods are typically used in studies involving subjective assessments or disagreements among multiple human readers.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI or CAD (Computer-Aided Detection) devices, which involve human interaction and diagnostic tasks. The device in question is a disposable medical glove, and its performance is evaluated through physical and chemical properties.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical product (nitrile examination gloves), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the tests performed on the gloves is based on:
- Objective measurements and standardized test procedures: For physical properties (tensile strength, elongation, dimensions), watertight integrity, and residual powder content, the ground truth is the direct measurement against the specified acceptance criteria of the ASTM standards.
- Biological assay results: For biocompatibility (irritation, sensitization, cytotoxicity), the ground truth is derived from the results of standardized biological assays (ISO 10993 series) interpreted against established biological safety criteria.
8. The sample size for the training set
This information is not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI models. The gloves are manufactured and tested against predefined specifications.
9. How the ground truth for the training set was established
This information is not applicable as 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.