(64 days)
A 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.
POWDERED VINYL EXAM GLOVES, WHITE
This document describes the acceptance criteria and study proving a device meets these criteria. The device is 'Powdered Vinyl Exam Gloves, White' (K031104) from Glormed International, Inc.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard/Test) | Reported Device Performance |
|---|---|
| ASTM D 5250-00E4 | Met or Exceeded |
| ASTM D 5151-99 | Met or Exceeded |
| ASTM D 6124-01 | Met or Exceeded |
| ISO 2859 | Met or Exceeded |
| MIL Std 105E | Met or Exceeded |
| Bio-Compatibility: Dermal Sensitization | Met or Exceeded |
| Bio-Compatibility: Primary Skin Irritation | Met or Exceeded |
| Bio-Burden (Procedure Method 8315) | Met or Exceeded |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each test. However, the tests referenced are recognized industry standards for gloves.
- Data Provenance: The document does not specify the country of origin of the data. It implies the data was collected as part of the regulatory submission process. The study appears to be prospective in the sense that the tests were conducted specifically to demonstrate compliance for this device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The "ground truth" for this type of device is established by meeting the specified performance standards rather than expert consensus on individual observations.
4. Adjudication Method for the Test Set
This information is not applicable as the evaluation is based on objective measurements against established technical standards, not subjective interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed and is not relevant for this type of medical device (examination gloves). Such studies are typically conducted for diagnostic imaging devices where human interpretation plays a role.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
A standalone performance study is not applicable as this is a physical medical device (gloves), not an algorithm or AI system.
7. Type of Ground Truth Used
The ground truth used for this device is based on objective measurements and adherence to established industry-specific performance standards (e.g., ASTM, ISO, MIL Std for physical properties, and specific bio-compatibility tests). There is no "expert consensus," "pathology," or "outcomes data" in the conventional sense for proving the functional performance of examination gloves.
8. Sample Size for the Training Set
There is no training set for this type of device. The device's performance is evaluated against predefined standards, not by training an algorithm.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set for this 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.