(134 days)
An Examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger, to prevent contamination between the patient and examiner.
The device is a glove with five fingers made from natural rubber that covers the hand on both sides up to the wrist, using a dip technology manufacturing process. The gloves are ambidextrous and therefore can be donned on either hand. The gloves are non sterile and for single use only, to be discarded after each examination is complete. The glove acts as a barrier between the examiner and the subject being examined in order to prevent contamination between the examiner and the subject.
This document describes the premarket notification (510(k)) for the "Preventive Care, Inc. Exam Perfect Powderfree Latex Examination Gloves Coated with Allogel®".
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standard Requirement) | Reported Device Performance (POWDER FREE LATEX EXAM GLOVES COATED WITH ALLOGEL® RESULTS) |
|---|---|
| Watertight (1000ml) (ASTM D5151, ISO 2859 Version 10-2006 GI AQL2.5) | Pass G1 AQL 2.5 |
| Length (mm) | |
| Size XS: Min 220 | 240 mm minimum for all sizes |
| Size S: Min 220 | |
| Size M: Min 230 | |
| Size L: Min 230 | |
| Size XL: Min 230 | |
| Palm Width (mm) | |
| Size XS: 70 ± 10 | 75 - 80 |
| Size S: 80 ± 10 | 83 - 84 |
| Size M: 95 ± 10 | 94 - 96 |
| Size L: 110 ± 10 | 107 - 109 |
| Size XL: 120 ± 10 | 113 - 114 |
| Thickness (mm) (Single Layer) | |
| Finger: Min 0.05 | Min 0.12 |
| Palm: Min 0.05 | Min 0.10 |
| Cuff: Min 0.05 | Min 0.08 |
| Physical Properties (ASTM D 412) | |
| Before Aging: | |
| Tensile Strength (MPa): Min 14 | 18 - 31 |
| Ultimate Elongation (%): Min 500 | 530 - 600 |
| After Aging: | |
| Tensile Strength (MPa): Min 14 | 18 - 29 |
| Ultimate Elongation (%): Min 400 | 500 - 550 |
| Powder Content (ASTM D6124) | |
| Max 2.0 mg/glove | Below 2.0 mg/glove |
| Residual Latex Proteins | |
| Max 200 micro grams/dm2 | Max 200 micro grams/dm2 |
Additional Acceptance Criteria and Reported Performance from Section 10 (Substantial Equivalence Comparison Table):
| Acceptance Criteria (Predicate Requirement) | Reported Device Performance (Applicant Performance) |
|---|---|
| TENSILE STRENGTH BEFORE AGING MINIMUM: 14 MPA (Predicate) | 18 MPA (Applicant) |
| AFTER AGING AT 70 DEG C 7 DAYS. MINIMUM: 14 MPA (Predicate) | 17 MPA (Applicant) |
| ULTIMATE ELONGATION BEFORE AGING MIN.: 500% (Predicate) | 797% (Applicant) |
| AFTER AGING AT 70 DEG C 7 DAYS. MINIMUM: 400% (Predicate) | 753% (Applicant) |
| WIDTH AT PALM (MEDIUM) +/- 5 MM: 95 MM (Predicate) | 98 MM (Applicant) |
| LENGTH (MEDIUM) +/- 5 MM: 245 MM (Predicate) | 241 MM (Applicant) |
| THICKNESS AT PALM MINIMUM: 0.07 MM (Predicate) | 0.11 MM (Applicant) |
| THICKNESS AT FINGER MINIMUM: 0.07 MM (Predicate) | 0.13 MM (Applicant) |
| THICKNESS AT CUFF MINIMUM: 0.07 MM (Predicate) | 0.08 MM (Applicant) |
| DETECTION OF PIN HOLES (ASTM D5151): AQL 2.5 MAX (Predicate) | AQL 1.5 (Applicant) |
| RESIDUAL POWDER: 2 MG/GLOVE (Predicate) | 0.58 MG/GLOVE (MEDIUM) (Applicant) |
| MINIMUM SHELF LIFE: 3 YEARS (Predicate) | 3 YEARS (Applicant) |
| POSITIVE BIOCOMPATABILITY TEST RESULTS: NON IRRITANT, NON SENSITIZER (Predicate) | NON IRRITANT, NON SENSITIZER (Applicant) |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document mentions "Data of an actual representative shipment is detailed in Section 14 (original submission)" for various tests. However, the specific sample sizes (e.g., number of gloves tested for watertight, tensile strength, etc.) are not explicitly stated in the provided text.
- Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. It refers to "an actual representative shipment," implying that the data was collected from manufactured products.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This device is an examination glove, and the "ground truth" for its performance is established through adherence to recognized international standards (ASTM, ISO) for physical and chemical properties. These standards define the test methodologies and acceptance criteria.
- Therefore, the "experts" involved are the organizations and committees that develop and validate these standards, and the personnel in testing laboratories who are qualified to perform these standard tests. The document does not specify the number or qualifications of individual experts who directly established the "ground truth" for this specific device's test set.
4. Adjudication method for the test set:
- For physical and chemical property testing (e.g., watertight, tensile strength), the "adjudication method" is the direct comparison of test results against the established quantitative acceptance criteria defined in the relevant ASTM and ISO standards. There is no mention of a human adjudication process (like 2+1 or 3+1) for these types of objective measurements.
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:
- This is a medical device (examination glove) and not an AI-powered diagnostic or assistive tool. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study to assess improvement with AI assistance is not applicable and was not conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Again, this is an examination glove, not an algorithm. Therefore, a standalone algorithm performance study is not applicable and was not conducted.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for this device's performance is based on established objective technical specifications and test methods outlined in international standards (ASTM D3578, ASTM D5712, ASTM D6124, ASTM D412, ASTM D5151, ISO 10993).
- For biocompatibility, the ground truth is established by passing standard biocompatibility test criteria (e.g., for not being sensitizers or irritants), which are laboratory tests.
8. The sample size for the training set:
- This is a manufactured physical good. The concept of a "training set" in the context of machine learning or AI is not applicable here. There is no algorithm being trained. Manufacturing processes are optimized through quality control and adherence to specifications, not a training set.
9. How the ground truth for the training set was established:
- As explained in point 8, the concept of a "training set" is not relevant to this type of device. The "ground truth" for the device's performance is established through adherence to the objective criteria of the specified ASTM and ISO standards during manufacturing and quality control.
§ 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.