(329 days)
The Palm-Pro Powder Free Nitrile 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)
Nitrile latex films form a barrier to body fluids and bloodborne pathogens. The nitrile rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. Nitrile rubber is known to create a barrier to bloodborne pathogens 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 D6319 and ASTM D5151 requirements.
The provided text describes information about powdered free nitrile examination gloves and does not mention anything about AI/ML device.
However, based on the information provided in the document, here's a breakdown of the acceptance criteria and the study that proves the device meets the criteria:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Specification (Standard) | Reported Device Performance |
|---|---|---|
| Non-Clinical Tests | ||
| Water Tightness | ASTM D6319-10 & ASTM D5151-92 | Meets or exceeds acceptable scores (Implied compliance with mentioned ASTM standards) |
| Clinical Tests | ||
| Safety - Rabbit Irritation | N/A (Internal test) | Passes |
| Safety - Guinea Pig Sensitization | N/A (Internal test) | Passes |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for the non-clinical or clinical tests.
- Data Provenance: The device is manufactured by Dipped Products (Thailand) Ltd, located in Thailand. The tests were likely conducted in Thailand or by contractors on behalf of the manufacturer. The document doesn't specify if the tests were retrospective or prospective, but clinical tests are generally prospective by nature.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The document does not provide information on the number of experts used or their qualifications for establishing the ground truth, particularly for the clinical safety tests (Rabbit Irritation and Guinea Pig Sensitization). These types of tests typically follow established laboratory protocols rather than relying on expert consensus for "ground truth" in the way an AI model might.
4. Adjudication Method for the Test Set:
The document does not mention any adjudication method. This is not relevant for this type of device testing, which relies on standardized objective measurements (ASTM for physical properties) and established biological testing protocols (for irritation and sensitization).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/ML devices where human readers interpret data, and the AI assists in that interpretation. This submission is for a physical medical device (examination gloves).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
No, a standalone (algorithm only) performance study was not done. This is not applicable to a physical medical device.
7. The Type of Ground Truth Used:
- Non-Clinical Tests (Water Tightness): The "ground truth" is defined by the performance standards set by ASTM D6319-10 and ASTM D5151-92. These standards outline the methodology and acceptance criteria for water leak tests in medical gloves.
- Clinical Tests (Safety - Rabbit Irritation, Guinea Pig Sensitization): The "ground truth" for these tests is based on established biological testing protocols designed to assess the potential for irritation and sensitization. A "Passes" outcome indicates that the device did not induce a significant adverse reaction according to the specific criteria of these protocols.
8. The Sample Size for the Training Set:
Not applicable. This submission is for a physical medical device, not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As above, this is not an AI/ML 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.