(71 days)
This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
Class I sterile nitrile examination glove, powder free and meeting all requirements of ASTM D3578-99, ASTM 6124-97, and ISO 11137, Part 2, Sterilization of Health Care Products.
This document describes the acceptance criteria and performance of the BioExam Powder Free, Sterile Nitrile Examination Glove as presented in its 510(k) summary (K062138).
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Acceptance Criteria (ASTM/ISO Standard or Specific Value) | Reported Device Performance (BioExam Glove) |
|---|---|---|
| Overall Length | 230mm Minimum (ASTM D3578-99) | 280 mm minimum (Sterile version) |
| Width | S: 80mm ±-10mm, M: 85mm±-10mm, L: 110mm ±-10mm, XL: 120mm±-10mm (ASTM D3578-99) | Small: 80mm ±-10mm, Medium: 90mm±-10mm, Medium-Large: 105mm±-10mm, Large: 111mm±-10mm, X-Large: 120mm±-10mm |
| Palm Thickness | 0.08mm minimum (ASTM D3578-99) | Not explicitly stated for sterile glove, but predicate's "0.09 - 0.13mm minimum" for non-sterile implies meeting/exceeding ASTM minimum. |
| Finger Thickness | 0.08mm minimum (ASTM D3578-99) | Not explicitly stated for sterile glove, but predicate's "0.10 - 0.14mm minimum" for non-sterile implies meeting/exceeding ASTM minimum. |
| Tensile Strength | 14 MPa Before Aging, 14 MPa After Aging (ASTM D3578-99) | Not explicitly stated for sterile glove, but predicate's "16 MPa Before Aging, 14 MPa After Aging" for non-sterile implies meeting/exceeding ASTM minimum. |
| Ultimate Elongation | 700% Before Aging, 500% min After Aging (ASTM D3578-99) | 500% minimum before aging, 400% minimum after aging (meeting ASTM D6319 requirements) *Note: This is lower than D3578-99, but meets D6319. |
| Protein | Zero/Below detection limit using ASTM D 6499 | Zero/Below detection limit using ASTM D 6499 |
| Barrier Integrity | Passed ASTM F 1671 | Passed ASTM F 1671 |
| Leak Acceptance | AQL 0.65 (ASTM D7161) | AQL 0.65 (ASTM D7161) |
| Biocompatibility | Passed cytotoxic end-point, ISO Closed Patch Sensitization, and ISO Skin Irritation testing. | Passed all testing (ISO Closed Patch Sensitization and ISO Skin Irritation). |
| Microbiological Viral Penetration | All acceptance criteria met for negative and positive control samples (negative for viral penetration in negative controls, positive in positive controls). | All acceptance criteria met for both the negative and positive control samples. (Negative control samples negative for viral penetration, positive control samples positive for viral penetration). |
| Residual Powder Content | N/A (Powder free device) | 0.4-1.6mg/glove (demonstrates low residual powder) |
| Presence of Cornstarch | N/A (Powder free device) | negative |
2. Sample size used for the test set and the data provenance:
- The document does not explicitly state the exact sample sizes for each physical and chemical test. However, it indicates compliance with ASTM and ISO standards (e.g., ASTM D3578-99, ASTM D6319, ASTM D6499, ASTM F1671, ASTM D7161, ISO 11137 Part 2, ISO Closed Patch Sensitization, ISO Skin Irritation). These standards typically specify the required sample sizes and testing methodologies.
- The data provenance is internal testing performed by the applicant and external testing by NAMSA for biocompatibility. The country of origin of the data is not specified beyond "NAMSA" being a testing laboratory. The studies are prospective in the sense that they are specifically conducted to demonstrate compliance of the device with the standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable to this type of device submission. The "ground truth" for examination gloves is established by conformance to predefined engineering standards (ASTM, ISO) and regulatory requirements, not through expert consensus on medical images or clinical outcomes. The tests are laboratory-based and objective against specified criteria.
4. Adjudication method for the test set:
- Not applicable. See point 3. The data is based on objective laboratory measurements against set thresholds, not on subjective interpretations requiring adjudication.
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 device is an examination glove, not an AI-powered diagnostic tool, so 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 is an examination glove, not an AI algorithm.
7. The type of ground truth used:
- The ground truth consists of internationally recognized and nationally adopted ASTM and ISO standards for physical properties, barrier integrity, biocompatibility, and sterility of medical examination gloves. These standards define the acceptable performance parameters.
8. The sample size for the training set:
- Not applicable. This is not a machine learning or AI device. There is no "training set" in the context of examination glove testing. The manufacturing process is subject to quality control, which involves ongoing testing, but this is distinct from a "training set" for an algorithm.
9. How the ground truth for the training set was established:
- Not applicable. As stated in point 8, there is no training set. The "ground truth" for glove performance is established by the accepted industry and regulatory standards.
§ 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.