(89 days)
The Disposable Vinyl/Nitrile Blend Medical Examination Gloves is intended for medical purposes that is worn on the examiners hands to prevent contamination between patient and examiner.
The subject device is powder free vinyl patient examination gloves. The subject device is blue. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is non-sterile.
The provided document is a 510(k) premarket notification for "Disposable Vinyl/Nitrile Blend Medical Examination Gloves." It describes non-clinical performance testing to demonstrate substantial equivalence to a predicate device, rather than a study involving an AI/CADe device. Therefore, much of the requested information regarding AI/CADe specific studies (such as MRMC studies, effect size of AI assistance, standalone performance, training set details, and expert ground truth establishment) is not applicable.
Here's the available information relevant to the acceptance criteria and the study (non-clinical testing) that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| No. | Name of the Test Methodology / Standard | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|---|
| 1 | ISO 10993-5 (Cytotoxicity) | Cytotoxicity | Non-cytotoxic | Under conditions of the study, did not show potential toxicity to L-929 cells. (Pass) |
| 2 | ISO 10993-10 (Irritation) | Irritation | Non-irritating | Under the conditions of the study, not an irritant. (Pass) |
| 3 | ISO 10993-10 (Sensitization) | Sensitization | Non-sensitizing | Under conditions of the study, not a sensitizer. (Pass) |
| 4 | ISO 10993-11 (Systemic toxicity) | Systemic toxicity | Non-Systemic toxic | Under the conditions of the study, the device does not elicit a systemic toxicity response in the model animal. (Pass) |
| 5 | ASTM D6124-06 (Powder Content) | Determine the amount of residual powder | Powder residue limit of 2.0 mg per glove | 0.15mg - 0.18 mg /glove (Meets requirements of ASTM D5250 ASTM D6124 - 06(2017) as stated in the "Analysis" section of Table4) |
| 6 | ASTM D5151-06 (Freedom from Holes) | Detection of holes in medical gloves | Samples number: 125 gloves, AQL: 2.5 (ISO 2859), Criterion ≤7 gloves for water leakage | no glove water leakage found (Pass) |
| 7 | ASTM D5250 (Physical Dimensions Test) | Physical Dimensions Test | Length(mm): ≥230; Width(mm): S: 85±5, M: 95±5, L: 105±5, XL: 115±5; Thickness (mm): Finger: ≥0.05, Palm: ≥0.05 | Lot no. 1: S: width: 83-88 mm, Length 231-238 mm (one data 227mm, 1 non-conforming, acceptable); M: width 92-96 mm, Length 233-236 mm; L: width 102-106 mm, Length 246-253 mm; XL: width 111-116 mm, Length 242-245 mm. Thickness: Finger 0.10-0.11 mm, Palm 0.07-0.08 mm. Lot no. 2: S: width: 82-85 mm, Length 232-235 mm; M: width 92-96 mm, Length 232-236 mm; L: width 103-106 mm, Length 243-249 mm; XL: width 111-116 mm, Length 237-243 mm. Thickness: Finger 0.11-0.12 mm, Palm 0.07-0.08 mm. Lot no. 3: S: width: 82-87 mm, M: width 93-96mm, Length 230-239 mm; L: width 103-107mm, Length 243-249 mm; XL: width 112-116 mm, Length 244-249 mm. Thickness: Finger 0.11 mm, Palm 0.07-0.08 mm. (Pass for all) |
| 8 | ASTM D412 (Physical properties) | Physical properties (Before & After Aging) | Before Aging: Tensile Strength: ≥11MPa; Ultimate Elongation: ≥300%. After Aging: Tensile Strength: ≥11MPa; Ultimate Elongation: ≥300%. | Before Aging: Lot 1: 12.7-24 MPa, 300.08-397.467 %; Lot 2: 15.1-25.1 MPa, 300.547-380.29 % (one data 228.080, 1 non-conforming, acceptable); Lot 3: 14.5-23.5 MPa, 303.365-389.716 %. (Pass for all) After Aging: Lot 1: 14.2-22.4 MPa, 301.276-394.245 %; Lot 2: 16.0-23.8 MPa, 300.79-399.170 %; Lot 3: 14.4-23.3 MPa, 307.674-399.758 %. (Pass for all) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not explicitly state the country of origin for the testing data. The company is based in China. The testing appears to be prospective, performed specifically for regulatory submission.
- ISO 10993-5, 10, 11 (Biocompatibility): The sample sizes are not explicitly stated for these tests beyond "conditions of the study" and "model animal" for systemic toxicity.
- ASTM D6124-06 (Powder Content): The sample size per glove for the reported residue is 0.15mg - 0.18 mg /glove, but the number of gloves tested for this average is not specified.
- ASTM D5151-06 (Freedom from Holes): 125 gloves were tested.
- ASTM D5250 (Physical Dimensions Test): Three lots (Lot no. 1, 2, 3) were tested. The specific number of gloves per lot for each size (S, M, L, XL) is not explicitly stated. For "Lot no. 1: Dimensions: S: ... (one data 227mm, the number of non-conforming is 1, acceptable)", this implies individual measurements were taken, but the total sample size isn't clear.
- ASTM D412 (Physical properties): Three lots (Lot 1, 2, 3) were tested. Similar to dimensions, the number of samples per lot for the tensile strength and ultimate elongation tests is not explicitly stated, although it notes "one data" point for Lot 2's ultimate elongation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. This is a medical device (gloves) and the testing involves physical and chemical property assessments, not interpretation by medical experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is not an AI/CADe study involving human reviewers.
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 is not an AI/CADe device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/CADe device. The performance data presented are for the device itself (gloves).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this device's performance is established by the specified industry standards (e.g., ISO 10993, ASTM D6124, ASTM D5151, ASTM D5250, ASTM D412). These standards define objective, measurable criteria for the physical and biological properties of patient examination gloves.
8. The sample size for the training set:
Not applicable. This is not an AI/CADe device and therefore does not have a training set.
9. How the ground truth for the training set was established:
Not applicable. This is not an AI/CADe 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.