(79 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
A patient examination glove is disposable device intended for medical a purpose that is worn on the examiner's s een and the circuins in the closed setimal examiner A patient examination glove is disposaolo device institution between patient and examiner.
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80L YZ, and meets all requirements of ASTM Standard D5250-00E4.
The provided text is a 510(k) summary for a medical device: "Grand Work Plastics Products Co., Ltd. Synthetic (White) Vinyl Patient Examination Gloves—Powder Free." This document describes the device and its compliance with established standards, but it does not involve AI/ML technology or a study proving its performance against a statistical acceptance criteria in the typical sense of AI/ML device evaluations.
Instead, this document details the device's adherence to existing ASTM standards and FDA requirements for patient examination gloves. Therefore, many of the requested elements for an AI/ML device study (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable to this type of medical device submission.
However, I can extract the information that is relevant to the acceptance criteria and how the device meets them based on the provided text.
Here's the breakdown:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard / Test) | Requirement | Reported Device Performance |
|---|---|---|
| ASTM Standard D5250-00E4 (Physical and Dimensions) | Meets all requirements of ASTM Standard D5250-00E4. | All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection Level S-2, AQL 4.0. The device conforms fully to ASTM-D-5250-00E4 standard. |
| FDA 1000 ml. Water Fill Test (based on ASTM D-5151-99) | Meets FDA pinhole requirements. | Conducted with samplings of AQL 2.5, Inspection Level I, meeting these requirements. The device meets pinhole FDA requirements. |
| Primary Skin Irritation Test | No primary skin irritant reactions. | Testing conducted with results showing no primary skin irritant reactions. The device meets biocompatibility requirements. |
| Skin Sensitization Test (Allergic Contact Dermatitis) | No sensitization reactions. | Testing conducted with results showing no sensitization reactions. The device meets biocompatibility requirements. |
| Residual Powder Test (based on ASTM D6124-01) | No more than 2 mg powder per glove for "powder-free" claims. | Conducted at finished inspection to ensure gloves meet "powder-free" claims (contain no more than 2 mg powder per glove). |
| General Controls and Labeling Claims | Meets all applicable 21 CFR references, general provisions of the Act (annual registration, listing, GMP, labeling, prohibitions against misbranding and adulteration), and does not make special labeling claims (e.g., hypoallergenic). Does not make new claims from predicate. | Conforms fully to ASTM-D-5250-00E4 standard as well as applicable 21 CFR references. No special labeling claims (e.g., hypoallergenic). No safety/efficacy issues or new claims from the "substantial equivalence" products cited. Meets labeling claims. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Physical and Dimensions Testing: Inspection Level S-2, AQL 4.0 (Specific number of gloves not stated, but defined by the AQL standard).
- Sample Size for Water Fill Test: AQL 2.5, Inspection Level I (Specific number of gloves not stated, but defined by the AQL standard).
- Sample Size for Other Tests (Skin Irritation, Sensitization, Residual Powder): Not explicitly stated, but implies sufficient sampling to meet the standard's requirements.
- Data Provenance: The tests were conducted internally by Grand Work Plastics Products Co., Ltd. (implied by "The standards used for Grand Work Plastics Products Co., Ltd. glove production are based on ASTM-D-5250-00E4. All testing meets requirements..."). This is a prospective testing of manufactured product batches. The country of origin of the data would be China, where the manufacturing company is located.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Not Applicable. The "ground truth" for this device is based on objective, standardized physical and chemical tests (e.g., water fill for pinholes, weighing for powder, biological assays for irritation). There are no human "experts" establishing a subjective ground truth in the way a radiologist would interpret an image. The standards themselves define the "truth."
4. Adjudication Method for the Test Set
- Not Applicable. As the tests are objective and quantitative (e.g., pass/fail a water leak, weight measurement), there's no need for adjudication among multiple human reviewers. The test results directly determine compliance with the standard's criteria.
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 a basic medical device (patient examination glove), not an AI/ML diagnostic or assistive tool. MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This device does not have an algorithm or AI component.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" is defined by established, objective ASTM and FDA standards for physical properties (dimensions, tensile strength, freedom from holes) and chemical properties (powder residue) and biological safety (biocompatibility through irritation/sensitization tests). It's based on adherence to these universally accepted and measurable criteria.
8. The Sample Size for the Training Set
- Not Applicable. This device does not involve an AI/ML model, so there is no "training set." The manufacturing process itself is implicitly "trained" through quality control and adherence to standards over time, but not in the machine learning sense.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set for an AI/ML model, this question is not relevant.
§ 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.