(71 days)
The Powder Free, Examination Glove is "a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.". (21CFR 880.6250).
Low protein claim surgical gloves are suitable in situations where healthcare worker or patient allergic sensitivity may be a factor. Powder free gloves are intended for use in situations where powder is not desirable.
Natural Rubber Latex films form an excellent barrier to body fluids and bloodborne pathogens. The latex rubber is water tight under normal conditions of use. It's tensile strength allows for movements necessary for medical treatment. Natural Rubber Latex is known to create a superior barrier to bloodborne pathogens and and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The leaching process removes traces of chemical accelerants that may be chemically irritating. The glove is manufactured in accordance with the requirements of ASTM D3578 and ASTM D5151 requirements.
The provided text describes the 510(k) submission K974065 for a Powder Free, Examination Glove (with low protein claim). This submission is for a medical device and primarily focuses on demonstrating substantial equivalence to a predicate device through performance testing against established standards, rather than complex studies involving human readers or AI.
Here's an analysis based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Device Performance (Proposed Device) | Study that Proves Device Meets Criteria |
|---|---|---|
| Performance Standard | ASTM D3578 | Non-clinical tests against ASTM D3578 |
| Water Tightness | ASTM D5151 | Non-clinical tests against ASTM D5151 |
| Protein Content (low protein claim) | ASTM D5712 (50 micrograms or less of total water extractable protein per gram) | Non-clinical tests against ASTM D5712 |
| Safety (Rabbit Irritation) | Passes | Clinical tests (Rabbit Irritation) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for each specific test (e.g., number of gloves tested for water tightness or protein content). The submission implies that sufficient samples were tested to demonstrate compliance with the ASTM standards.
- Data Provenance: Not explicitly stated as "country of origin" or "retrospective/prospective." However, the tests are "non-clinical tests" and "clinical tests" used to demonstrate equivalence, implying they were conducted specifically for this submission. The submitter is Tillotson Healthcare Corporation, located in Bedford, NH, U.S.A., so it's reasonable to infer the testing was likely conducted in the U.S. or at labs compliant with U.S. standards. The "clinical tests" for safety (rabbit irritation) would typically be prospective for a new device submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is an examination glove, and the "ground truth" is established by adherence to recognized ASTM consensus standards (D3578, D5151, D5712) and a standard safety test (Rabbit Irritation Test). These standards define objective pass/fail criteria, not subjective expert judgment.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the evaluation is against objective, pre-defined ASTM standards, not subjective assessments requiring adjudication by multiple experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This submission is for a physical medical device (an examination glove), not an AI or imaging diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers or AI assistance is not relevant or applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This submission is for a physical medical device. The concept of an "algorithm only" or "standalone" performance test is not applicable to an examination glove.
7. The Type of Ground Truth Used
The ground truth used is based on consensus standards and objective physical/chemical measurements:
- ASTM D3578: Standard Specification for Rubber Examination Gloves. This defines physical properties like tensile strength and elongation.
- ASTM D5151: Standard Test Method for Detection of Holes in Medical Gloves. This defines water-tightness criteria.
- ASTM D5712: Standard Test Method for the Analysis of Aqueous Extractable Protein in Natural Rubber and Its Products Using the Modified Lowry Method. This defines the method and criteria for low protein claims.
- Rabbit Irritation Test: A standard biological test to assess skin irritation (a form of adverse effect on biological systems).
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that requires a "training set." The device is manufactured according to specifications and then tested against established standards.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of medical device submission.
§ 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.