(233 days)
Pro Guard ® Nitrile Powder free Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Black Nitrile Examination Gloves Powder Free are Class I patient examination gloves bearing the product code Nitrile - LZA (21 CFR 880.6250). The gloves are made from acrylonitrile-butadiene copolymer dispersion. These gloves are black in color and are powder free.
The provided document is a 510(k) summary for a medical device: "Pro Guard® Nitrile Powder Free Examination Glove." This type of document is a submission to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, not typically a study proving the efficacy or performance of a new medical AI device.
Therefore, the requested information regarding acceptance criteria and study design for an AI device (e.g., sample size for test/training sets, expert ground truth, MRMC studies, standalone performance) is not applicable to this document.
The document discusses the performance of a physical medical device (gloves) against established standards for physical properties and biocompatibility.
Here's the relevant information extracted from the provided text, structured to best fit the spirit of your request, but acknowledging the difference in device type:
Device: Pro Guard® Nitrile Powder Free Examination Glove
Device Type: Class I, reserved Non-powdered patient examination glove
1. Acceptance Criteria and Reported Device Performance
| Characteristic | Standard | Acceptance Criteria | Reported Device Performance* | Status |
|---|---|---|---|---|
| Dimension | ||||
| Length | ASTM D6319-19 | Min 230 mm for all sizes | Extra Small: min 240 mm; Small: min 243 mm; Medium: min 241 mm; Large: min 240 mm; Extra Large: min 240 mm | Pass |
| Width | ASTM D6319-19 | XS: 70±10 mm; S: 80±10 mm; M: 95±10 mm; L: 110±10 mm; XL: 120±10 mm | XS: 75 mm; S: 85 mm; M: 95 mm; L: 105 mm; XL: 115 mm | Pass |
| Thickness (Palm) | ASTM D6319-19 | 0.05 mm min for all sizes | XS, S, M, L, XL: 0.09 mm | Pass |
| Thickness (Finger) | ASTM D6319-19 | 0.05 mm min for all sizes | XS: 0.12 mm; S: 0.13 mm; M: 0.12 mm; L: 0.12 mm; XL: 0.12 mm | Pass |
| Watertight Test | ASTM D5151-19 | Sample size: 200 pcs; Inspection level: GI; AQL 1.5; Acceptance Number: 7; Rejection Number: 8 | 0 (Zero) defects for all sizes (Extra Small, Small, Medium, Large, Extra Large) | Pass |
| Residual Powder | ASTM D6124-06 (Reapproved 2017) | 2 mg per glove or less | XS: 1.35 mg/glove; S: 1.42 mg/glove; M: 1.24 mg/glove; L: 1.34 mg/glove; XL: 1.36 mg/glove | Pass |
| Physical Properties: Tensile Strength | ||||
| Before Aging | ASTM D6319-19 | 14 MPa min for all sizes | XS: 18.08 MPa; S: 18.37 MPa; M: 24.56 MPa; L: 18.30 MPa; XL: 18.20 MPa | Pass |
| After Aging | ASTM D6319-19 | 14 MPa min for all sizes | XS: 14.01 MPa; S: 14.08 MPa; M: 20.41 MPa; L: 14.00 MPa; XL: 14.00 MPa | Pass |
| Physical Properties: Ultimate Elongation | ||||
| Before Aging | ASTM D6319-19 | 500% Min for all sizes | XS: 611 %; S: 612%; M: 645 %; L: 620%; XL: 587% | Pass |
| After Aging | ASTM D6319-19 | 400% Min for all sizes | XS: 412 %; S: 408%; M: 584%; L: 403%; XL: 416% | Pass |
| Biocompatibility | ||||
| Primary Skin Irritation | ISO 10993-10 Third Edition 2010-08-01 | Not an irritant | Under the conditions of the study, not an irritant | Same |
| Dermal Sensitization | ISO 10993-10 Third Edition 2010-08-01 | Not a sensitizer | Under the conditions of the study, not a sensitizer | Same |
| In vitro cytotoxicity | ISO10993-5:2009(E) | Not applicable (predicate had no data) - New device showed cytotoxicity at high concentrations, but non-cytotoxic at 1:16 and 1:32. | Under the conditions of the study, cytotoxic for undiluted, 1:2, 1:4 and 1:8 dilutions, but non-cytotoxic for 1:16 and 1:32 dilutions. | Different (but deemed acceptable) |
| Acute Systemic Toxicity | ISO10993-11:2017(E) | Not applicable (predicate had no data) - New device showed no systemic toxicity. | Under the conditions of the study, did not induce any systemic toxicity. | Different (but deemed acceptable) |
*The "Reported Device Performance" column directly reflects the "Result" column from the provided 510(k) summary (page 7).
The following points are not applicable to this 510(k) submission for a physical medical glove. They typically pertain to AI/machine learning medical devices.
- 2. Sample sizes for test set and data provenance: Non-clinical physical tests are described, not AI model testing. The sample sizes for each test are listed next to the "Acceptance Criteria," e.g., 200 pieces for watertight test, 5 pieces for residual powder. The data provenance is implied to be from the manufacturer's own testing in Thailand.
- 3. Number of experts used to establish ground truth & qualifications: Ground truth for physical properties is established by objective measurements against international standards (ASTM, ISO), not by expert consensus in the way an AI medical imaging task would require.
- 4. Adjudication method: Not applicable as it's not an AI performance study requiring human interpretation.
- 5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This is for evaluating changes in human reader performance with AI assistance.
- 6. Standalone (algorithm only without human-in-the-loop performance) study: Not applicable. This is a physical device, not an algorithm.
- 7. Type of ground truth used: For physical properties, the ground truth is objective measurement against specified standards (e.g., length in mm, thickness in mm, tensile strength in MPa, number of holes). For biocompatibility, it's based on standardized biological tests.
- 8. Sample size for the training set: Not applicable. This is not an AI/ML device that requires training data.
- 9. How the ground truth for the training set was established: Not applicable.
§ 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.