(88 days)
Orange Non Sterile Powder Free Nitrile Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Orange Non Sterile Powder Free Nitrile Examination are Class I Patient Examination Gloves. They are ambidextrous, and come in different sizes - Extra Small, Small, Medium, Large and Extra Large. Gloves meet the specification of ASTM D6319-10 and follows the FDA Medical Glove Guidance Manual.
This document describes the acceptance criteria and the study proving that "Orange Non Sterile Powder Free Nitrile Examination Gloves" meets these criteria.
Acceptance Criteria and Reported Device Performance
The device, "Orange Non Sterile Powder Free Nitrile Examination Gloves," demonstrates substantial equivalence to its predicate device (K143247) by meeting the following acceptance criteria based on established ASTM standards and FDA guidance:
| Criteria | Acceptance Threshold (ASTM D6319-10 unless specified) | Proposed Device Performance | Remarks |
|---|---|---|---|
| Physical Properties | |||
| Before Aging | |||
| Tensile Strength | 15 MPa min | 15 MPa min | Meets acceptance criteria and is same as predicate. |
| Ultimate Elongation | 500% min | 500% min | Meets acceptance criteria and is same as predicate. |
| After Aging | |||
| Tensile Strength | 14 MPa min | 14 MPa min | Meets acceptance criteria and is same as predicate. |
| Ultimate Elongation | 400% min | 400% min | Meets acceptance criteria and is same as predicate. |
| Freedom from Holes | In accordance with ASTM D5151-06, AQL 2.5/Inspection Level G-I | In accordance with ASTM D5151-06, AQL 2.5/Inspection Level G-I | Meets acceptance criteria and is similar to predicate. |
| Powder Content | Max. 0.50 mg per glove | Max. 0.50 mg per glove | Meets acceptance criteria. Predicate had 0.40mg/glove, but both meet the specified maximum. |
| Biocompatibility | Not an irritant | Not an irritant | Meets acceptance criteria. |
| Irritation | Not a sensitizer | Not a sensitizer | Meets acceptance criteria. |
| Sensitization | |||
| Dimensions | (ASTM D6319-10) | ||
| Length | Minimum 230 mm | Minimum 230 mm (for all sizes) | Meets acceptance criteria and is same as predicate. |
| Width (XS, S, M, L, XL) | 70, 80, 95, 110, 120 mm (±0.10) | 70, 80, 95, 110, 120 mm (±0.10) | Meets acceptance criteria and is same as predicate. |
| Thickness | (Palm/Finger) - Not specified numerically but referred to ASTM D6319-10 | (Palm/Finger) - Not specified numerically but referred to ASTM D6319-10 | Meets referenced standard. |
Study Details
The provided document describes a non-clinical performance study to demonstrate substantial equivalence, rather than a traditional medical device clinical trial with a test set of data and ground truth established by experts.
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Sample size used for the test set and the data provenance: Information regarding the specific sample sizes for tests such as tensile strength, elongation, freedom from holes, and powder content is not explicitly stated in this summary. The tests were performed in accordance with ASTM standards, which would specify appropriate sample sizes. The data provenance is internal testing conducted by the manufacturer, Central Medicare Sdn. Bhd., in Malaysia.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is not applicable as the evaluation is based on objective measurements against engineering and material standards (ASTM, ISO) rather than expert interpretation of medical images or patient outcomes. The "ground truth" is defined by these established industry standards.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: This is not applicable as the evaluation relies on direct physical and chemical measurements rather than subjective assessment requiring adjudication.
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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 is not applicable. The device is an examination glove, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is not applicable. The device is an examination glove, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" is based on established industry standards and test methods, specifically:
- ASTM D6319-10: Standard Specification for Nitrile Examination Gloves for Medical Application
- ASTM D5151-06 (Reapproved 2011): Standard Test Method for Detection of Holes in Medical Gloves
- ASTM D6124-06 (Reaffirmation 2011): Standard Test Method for Residual Powder on Medical Gloves
- ISO 2859-1:1999: Sampling Procedures for Inspection by Attributes - Part I: Sampling Plans Indexed by Acceptable Quality Level (AQL) for Lot-by-Lot Inspection
- ISO 10993-10:2010: Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
- ASTM D412-16: Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers - Tension
- ASTM D7160-16: Standard Practice for Determination of Expiration Dating for Medical Gloves
- ASTM D573-04: Standard Test Method for Rubber—Deterioration in an Air Oven
- 16 CFR 1500.41: Method of testing primary irritant substances
- FDA Medical Glove Guidance Manual (Document issued on January 22, 2008)
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The sample size for the training set: This is not applicable. This is a physical medical device, not a machine learning algorithm requiring a training set.
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How the ground truth for the training set was established: This is not applicable for the same reason as above.
§ 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.