(114 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs, per ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
The subject device is single use, disposable gloves intended for medical purposes to be worn on the examiner's hands to prevent contamination between patient and examiner. The qloves are powder-free, ambidextrous with beaded cuff, blue colored, nitrile, and tested for use with chemotherapy drugs. The gloves are offered in five sizes: extra-small, small, medium, large, and extra-large.
The provided text describes the acceptance criteria and performance of a medical device, specifically "Disposable Nitrile Medical Examination Gloves (Tested for Use with Chemotherapy Drugs)" (K212834). However, it is not an AI/ML medical device, but rather a physical product.
Therefore, many of the requested criteria for an AI/ML study (such as sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, training set details, etc.) are not applicable to this document. The document details bench testing and biocompatibility assessments, which are standard for physical medical gloves.
Below is a table summarizing the acceptance criteria and reported device performance based on the provided document, along with a clarification of why other requested information is not present for this type of device.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance | Conclusion |
|---|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test | |||
| Length (mm) | XS/S: ≥220; M/L/XL: ≥230 | All sizes: >230 | Pass | |
| Width (mm) | XS: 70±10; S: 80±10; M: 95±10; L: 110±10; XL: 120±10 | XS: 77-79; S: 82-86; M: 95-97; L: 104-106; XL: 115-117 | Pass | |
| Thickness (mm) | Finger: ≥0.05; Palm: ≥0.05 | XS: Finger 0.10-0.12, Palm 0.06-0.10; S: Finger 0.09-0.12, Palm 0.07-0.09; M: Finger 0.08-0.12, Palm 0.06-0.09; L: Finger 0.10-0.13, Palm 0.06-0.09; XL: Finger 0.11-0.12, Palm 0.06-0.08 | Pass | |
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 | XS: 0/125 leaks; S: 1/125 leaks; M: 0/125 leaks; L: 2/125 leaks; XL: 2/125 leaks | Pass |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 240 Minutes; Cyclophosphamide (Cytoxan) 20.0 mg/ml: > 240 Minutes; Dacarbazine (DTIC) 10.0 mg/ml: > 240 Minutes; Doxorubicin HCl 2.0 mg/ml: > 240 Minutes; Etoposide 20.0 mg/ml: > 240 Minutes; Fluorouracil 50.0 mg/ml: > 240 Minutes; Methotrexate 25 mg/ml: > 240 Minutes; Mitomycin C 0.5 mg/ml: > 240 Minutes; Paclitaxel 6.0 mg/ml: > 240 Minutes; Thio Tepa 10.0 mg/ml: 45.8 Minutes; Vincristine Sulfate 1.0 mg/ml: > 240 Minutes | All reported as tested and comply, noting low permeation times for Carmustine and Thio-Tepa with specific warnings. | |
| ISO 10993-5 | Cytotoxicity | Non-cytotoxic | Under conditions of the study, did not show potential toxicity to L-929 cells. | Pass |
| ISO 10993-10 | Irritation | Non-irritating | Under the conditions of the study, not an irritant. | Pass |
| ISO 10993-10 | Sensitization | Non-sensitizing | Under conditions of the study, not a sensitizer. | Pass |
Clarification regarding AI/ML specific questions:
The provided document is a 510(k) summary for a physical medical device (examination gloves), not an Artificial Intelligence/Machine Learning (AI/ML) based medical device. Therefore, the following requested information is not applicable to this submission:
- Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable for physical product testing. Performance testing is done via bench methods on manufactured samples.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical properties (e.g., tensile strength, hole detection) is established through standardized laboratory test methods, not expert consensus.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Testing involves measurable physical properties.
- 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 a physical device, not an AI assistance tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for this device is based on standardized test methods and measurements (bench testing) per ASTM and ISO standards, not medical imagery or pathology.
- The sample size for the training set: Not applicable. The device does not involve machine learning and therefore has no "training set."
- How the ground truth for the training set was established: Not applicable.
In summary, the document details the safety and performance evaluation of a medical glove against established national and international standards for physical properties and biocompatibility. It successfully demonstrated substantial equivalence to a predicate device through these non-clinical tests.
§ 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.