(87 days)
The nitrile examination glove is intended to be worn on the hands of examiner's to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.
The propose devices is powder free nitrile patient examination gloves, provided as non-sterile and disposable device. The proposed devices are provided with white, black and pink color. There are six sizes, extra-small, medium, large and extra-large, extra extra-large for optional.
This is a 510(k) summary for a medical device (Nitrile Examination Gloves), not for an AI/ML powered device, therefore, the requested information elements related to AI/ML device studies (such as sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set sample size, and ground truth establishment for training set) are not applicable.
The document describes non-clinical testing performed to demonstrate substantial equivalence to a predicate device.
Here's the table of acceptance criteria and reported device performance based on the provided document:
Acceptance Criteria and Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance | Result |
|---|---|---|---|---|
| ASTM D6319 - Physical Dimensions Test | ||||
| Length (XS) | $\ge$ 220 mm | 226 mm | Pass | |
| Width (XS) | 70 ± 10 mm | 73 mm | Pass | |
| Length (S) | $\ge$ 220 mm | 225 mm | Pass | |
| Width (S) | 80 ± 10 mm | 85 mm | Pass | |
| Length (M) | $\ge$ 230 mm | 235 mm | Pass | |
| Width (M) | 95 ± 10 mm | 98 mm | Pass | |
| Length (L) | $\ge$ 230 mm | 234 mm | Pass | |
| Width (L) | 110 ± 10 mm | 115 mm | Pass | |
| Length (XL) | $\ge$ 230 mm | 235 mm | Pass | |
| Width (XL) | 120 ± 10 mm | 123 mm | Pass | |
| Length (XXL) | $\ge$ 230 mm | 235 mm | Pass | |
| Width (XXL) | $\ge$ 120 mm | 124 mm | Pass | |
| Thickness | ||||
| Finger Thickness | $\ge$ 0.08 mm | X-Small: 0.104 mm; Small: 0.106 mm; Medium: 0.104 mm; Large: 0.105 mm; X-Large: 0.106 mm; XX-Large: 0.105 mm | Pass | |
| Palm Thickness | $\ge$ 0.05 mm | X-Small: 0.059 mm; Small: 0.060 mm; Medium: 0.060 mm; Large: 0.062 mm; X-Large: 0.061 mm; XX-Large: 0.058 mm | Pass | |
| Physical Properties (Before Aging) | ||||
| Tensile Strength | $\ge$ 14 MPa | Lot1: 17.6 MPa; Lot2: 18.5 MPa; Lot3: 18.2 MPa | Pass | |
| Ultimate Elongation | $\ge$ 500% | Lot1: 552%; Lot2: 573%; Lot3: 583% | Pass | |
| Physical Properties (After Aging) | ||||
| Tensile Strength | $\ge$ 14 MPa | Lot1: 19.8 MPa; Lot2: 20.3 MPa; Lot3: 20.1 MPa | Pass | |
| Ultimate Elongation | $\ge$ 500% | Lot1: 521%; Lot2: 518%; Lot3: 526% | Pass | |
| ASTM D5151 - Freedom from Pinholes | Freedom from pinholes | Meet the requirements of ASTM D5151 Test for AQL 2.5 | Lot1: $\le$ AQL 2.5; Lot2: $\le$ AQL 2.5; Lot3: $\le$ AQL 2.5 | Pass |
| ASTM D6124 - Powder Residue | Powder Residue | $\le$ 2.0 mg | Lot1: 1.2 mg; Lot2: 1.5 mg; Lot3: 1.2 mg | Pass |
| ISO 10993-10 - Irritation | To determine if the finished device material is an irritant | Non-irritating | Under the conditions of the study, not an irritant | Pass |
| ISO 10993-10 - Sensitization | To determine if the finished device material is a sensitizer | Non-sensitizing | Under conditions of the study, not a sensitizer | Pass |
| ISO 10993-11 - Systemic Toxicity | To determine if the finished device material extracts pose a systemic toxicity concern | Non-acute systemic toxicity | Under conditions of the study, did not show acute systemic toxicity in vivo | Pass |
Study Details
- Sample size used for the test set and the data provenance: Not applicable. These are non-clinical bench tests on physical products, not an AI/ML test set. The tests were performed on "Lots" of the gloves (Lot1, Lot2, Lot3). The specific sample size for each test within these lots is not specified in this document but implied to be sufficient for meeting the ASTM/ISO standards. The data provenance is from non-clinical testing of the manufacturing output.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as these are objective physical and chemical tests, not requiring expert ground truth in the context of AI/ML evaluation.
- Adjudication method for the test set: Not applicable. The results are based on objective measurements against defined standards.
- 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 concerns a physical medical device (gloves), not an AI/ML powered device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This concerns a physical medical device (gloves), not an AI/ML powered device.
- The type of ground truth used: For physical/chemical properties (e.g., length, thickness, tensile strength, freedom from pinholes, powder residue), the "ground truth" is the quantitative measurement obtained through standardized test methods (ASTM and ISO standards) and compared against pre-defined numerical or qualitative acceptance criteria. For biocompatibility tests (irritation, sensitization, systemic toxicity), the ground truth is established by the outcome of the biological assays as per ISO 10993 standards.
- The sample size for the training set: Not applicable. This is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable. This is not an AI/ML 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.