(257 days)
The Cream Stretch Vinyl Patient Examination Glove (Non-Sterile) and White Vinyl Patient Examination Glove (Non-Sterile) are disposable devices intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner. They are both sold as non-sterile.
Cream Stretch Vinyl Patient Examination Glove (Non-Sterile) and White Vinyl Patient Examination Glove (Non-Sterile) are patient examination gloves available in S, M, L, XL. They are provided non-sterile and meet the entire requirement of ASTM standard D 5250-06, except for sterility requirements.
This document describes the marketing authorization for examination gloves, not an AI/ML powered medical device. Therefore, the information regarding acceptance criteria, study details, and related elements specific to AI/ML device evaluations outlined in the request cannot be extracted from this document.
The document primarily focuses on demonstrating substantial equivalence of the "Cream Stretch Vinyl Patient Examination Glove (Non-Sterile)" and "White Vinyl Patient Examination Glove (Non-Sterile)" to a predicate device (K100978: Powder-Free Non-Sterile Vinyl Examination Glove).
Here's the relevant information that can be extracted, pertaining to the glove, not an AI device:
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristics | Acceptance Criteria (from ASTM D5250-06, D5151-06, D6124-06, 21 CFR 800.20 or N/A) | Cream Stretch Vinyl Patient Examination Glove (Non-Sterile) Performance | White Vinyl Patient Examination Glove (Non-Sterile) Performance | Remarks |
|---|---|---|---|---|
| Dimension | Meets ASTM D 5250-06 | Length 246mm, Width: S=85mm, M=95mm, L=105mm, XL=115mm, Finger thickness = 0.05mm, Palm thickness = 0.08mm | Length: 243mm, Width: S=85mm, M=95mm, L=105mm, XL=115mm, Finger thickness = 0.05mm, Palm thickness = 0.08mm | Both subject devices meet ASTM D 5250-06 |
| Physical Properties | Meets ASTM D 5250-06 | Tensile strength = 16.3MPa, Elongation = 391% | Tensile strength = 15.7MPa, Elongation = 385% | Both subject devices meet ASTM D 5250-06 |
| Freedom from pinholes | Meets 21 CFR 800.20 (AQL 1.5 per ASTM D5151-06) | Pinhole = 8/500, AQL 1.5 | Pinhole = 10/500, AQL 1.5 | Both subject devices meet ASTM D5151-06 |
| Powder Residual | Meets ASTM D6124-06 (and D5250-06) | Powder residue = 1mg | Powder residue = 1mg | Both subject devices meet ASTM D5250-06 and D6124-06 |
| Cytotoxicity (ISO10993-5) | Passes | Passes | Passes | Evaluated as per ISO 10993-5 |
| Biocompatibility - Primary Dermal Irritation | Not an irritant | Under the conditions of the study, not an irritant. | Under the conditions of the study, not an irritant. | Conducted on rabbits, in accordance with FDA Blue Book Memo #G95-1 and ISO 10993-1 |
| Biocompatibility - Dermal Sensitization | Not a sensitizer | Under conditions of the study, not a sensitizer. | Under conditions of the study, not a sensitizer. | Conducted on guinea pig, in accordance with FDA Blue Book Memo #G95-1 and ISO 10993-1 |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Sizes:
- Pinhole: 500 gloves for each device type (Cream Stretch and White Vinyl).
- Other tests (Dimensions, Physical Properties, Powder Residual, Biocompatibility) do not specify the exact sample size in this summary, but indicate compliance with ASTM standards which would define sample sizes.
- Data Provenance: Not explicitly stated beyond "provided in support of the substantial equivalence determination." This implies the tests were conducted by the manufacturer, Lifestyle Safety Products (Hui Zhou) Co., Ltd., which is based in China. The data would be derived from laboratory testing of the manufactured gloves. The document does not specify if the testing was retrospective or prospective in the context of an FDA submission, but it is typically prospective testing performed on representative samples for premarket submissions.
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. For physical and biocompatibility testing of medical gloves, "ground truth" is established by adherence to recognized international and national standards (e.g., ASTM standards, ISO 10993). The results are objective measurements and expert consensus is not typically required in the same way it would be for an AI diagnostic algorithm.
4. Adjudication method for the test set:
Not applicable. Testing involves objective measurements against established standard criteria, not 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 is for an examination glove, not an AI/ML powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is for an examination glove, not an AI/ML powered device.
7. The type of ground truth used:
The "ground truth" for the device's performance is based on objective measurements obtained through laboratory testing against established international and national standards (e.g., ASTM D5250-06, ASTM D5151-06, ASTM D6124-06, ISO 10993-1, ISO 10993-5, 21 CFR 800.20) for medical devices, specifically patient examination gloves.
8. The sample size for the training set:
Not applicable. This is for an examination glove; there is no "training set" in the context of AI/ML.
9. How the ground truth for the training set was established:
Not applicable. There is no training set for this type of 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.