(123 days)
A powder-free patient 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. The glove was tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment for Medical Gloves to Permeation by Chemotherapy Drugs. Please note that the following drug has an extremely low permeation time: Carmustine: 47.9 minutes (Blue), 49.6 minutes (Green), 27.6 minutes (Black). Warning: Do not use with Carmustine.
Microflex® Nitrile Patient Examination Gloves Blue Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex® Nitrile Patient Examination Gloves Green Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex® Nitrile Patient Examination Gloves Black Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate are non-sterile, single use only, disposable, powder free examination gloves are made of nitrile butadiene rubber. A polyacrylic polymer is applied to the inner surface of the gloves to make donning easy.
Characteristics:
- . Ambidextrous with beaded cuff and straight fingers
- . Finger-textured
- Blue, green, or black colored .
- . Four (4) sizes - small, medium, large, and extra-large
- . Tested against chemotherapy drugs and fentanyl citrate
High levels of ozone will degrade rubber material of the gloves; therefore, the gloves should be protected from ozone in particular.
The gloves are designed to meet the specifications of ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application.
This is an analysis of a 510(k) Premarket Notification for medical gloves, which are considered Class I devices. The submission focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical performance testing against established standards rather than clinical studies involving human patients or complex AI algorithms.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally established by referring to ASTM and ISO standards for examination gloves. The reported device performance indicates that the gloves meet or exceed these standards.
Microflex Nitrile Patient Examination Gloves (Blue, Green, Black)
| Characteristics | Standard/Test/FDA Guidance | Acceptance Criteria (from Standard, implied) | Reported Device Performance |
|---|---|---|---|
| Physical Characteristics: | |||
| Dimensions: | ASTM D6319-10 | Meets ASTM D6319-10 requirements | Meets ASTM D6319-10 requirements for length, width, and thickness |
| Length | Minimum 230mm | Minimum 240mm (Exceeds) | |
| Palm width (S) | 80 ± 10 mm | 85 ± 5 mm (Meets) | |
| Palm width (M) | 95 ± 10 mm | 95 ± 5 mm (Meets) | |
| Palm width (L) | 110 ± 10 mm | 105 ± 5 mm (Meets) | |
| Palm width (XL) | 120 ± 10 mm | 115 ± 5 mm (Meets) | |
| Thickness (single-wall): | |||
| Finger | minimum 0.05 mm | Finger - min 0.09 mm (Exceeds) | |
| Palm | minimum 0.05 mm | Palm - min 0.06 mm (Exceeds) | |
| Cuff | Not specified (implied to meet standard) | Cuff - min 0.05 mm | |
| Physical Properties: | ASTM D6319-10 | Meets ASTM D6319-10 requirements | Meets ASTM D6319-10 requirements for tensile strength and ultimate elongation before and after accelerated aging |
| Tensile Strength (Before Aging) | minimum 14 MPa | minimum 16 MPa (Exceeds) | |
| Tensile Strength (After Aging) | minimum 14 MPa | minimum 14 MPa (Meets) | |
| Ultimate Elongation (Before Aging) | minimum 500% | minimum 500% (Meets) | |
| Ultimate Elongation (After Aging) | minimum 400% | minimum 400% (Meets) | |
| Freedom from holes: | ASTM D6319-10, ASTM D5151-06 | AQL 2.5 | Meets or exceeds ASTM D6319-10 and ASTM D5151-06 requirements of AQL 2.5 |
| Powder Residual: | ASTM D6319-10, ASTM D6124-06 | ≤ 2 mg per glove | Meets applicable requirement for powder free; ≤ 2 mg per glove |
| Biocompatibility: | |||
| ISO In Vitro Cytotoxicity | ISO 10993-5:2009 | Non-cytotoxic | Undiluted, 1:2, 1:4, 1:8, 1:16 dilution was cytotoxic. 1:32 and 1:64 are not cytotoxic. (Requires clarification on acceptable dilution for "non-cytotoxic") |
| ISO Skin Irritation Study | ISO10993-10:2010 | Not an irritant | Under the conditions of the study, not an irritant |
| ISO Maximization Sensitization Study | ISO 10993-10:2010 | Not a sensitizer | Under the conditions of the study, not a sensitizer |
| ISO Acute Systemic Toxicity | ISO 10993-11:2006 | No evidence of systemic toxicity | Under the conditions of the study, no evidence of systemic toxicity |
| Chemotherapy Drug Permeation (ASTM D6978-05): | ASTM D6978-05 | No permeation within a specified time* | Varies by drug and glove color. Carmustine has low permeation (27.6 to 49.6 minutes), others generally >240 minutes. |
Note: For chemotherapy drug permeation, the acceptance criterion isn't explicitly stated as a single value (e.g., ">X minutes"), but the comparison is made against the predicate device and the standard, indicating the longer the breakthrough time, the better the performance. The warning for Carmustine suggests that its specific permeation time is deemed too low for safe use with these gloves.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the total sample size for each specific test. However, for the Chemotherapy Drug Permeation testing, it indicates "Average Minimum Breakthrough Detection Time (Sample 1,2,3) (Minutes)", implying that at least 3 samples were tested for each drug/glove combination.
The provenance of the data is not specified in terms of country of origin or whether it was retrospective or prospective. It is generally understood that such testing is conducted in a laboratory setting for regulatory submission.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. This submission pertains to physical and chemical performance testing of medical gloves, not a diagnostic device that requires expert interpretation of images or patient data to establish ground truth. The "ground truth" for these tests is defined by the objective measurements according to the specified ASTM and ISO standards (e.g., direct measurement of length, tensile strength testing, chemical permeation detection).
4. Adjudication Method for the Test Set
Not applicable. As there are no human interpretations or judgments required for establishing the "ground truth" (instead, it's objective measurement against standards), no adjudication method (like 2+1 or 3+1) is mentioned or relevant.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No MRMC study was done. This is a Class I medical device (gloves) and not an AI-assisted diagnostic tool. Therefore, the concept of human readers improving with AI assistance is not applicable.
6. Standalone Performance Study (Algorithm Only)
Not applicable. This device does not involve an algorithm. The performance studies are laboratory tests of the physical, chemical, and biological properties of the gloves.
7. Type of Ground Truth Used
The ground truth for the performance claims is based on objective measurements obtained through standardized laboratory tests according to recognized national and international standards, specifically:
- ASTM D6319-10: Standard Specification for Nitrile Examination Gloves for Medical Application (for dimensions and physical properties like tensile strength, elongation, freedom from holes).
- ASTM D5151-06: Standard Test Method for Detection of Holes in Medical Gloves.
- ASTM D6124-06: Standard Test Method for Residual Powder on Medical Gloves.
- ASTM D6978-05: Standard Practice for Assessment for Medical Gloves to Permeation by Chemotherapy Drugs.
- ISO 10993-5:2009: Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity.
- ISO 10993-10:2010: Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
- ISO 10993-11:2006: Biological evaluation of medical devices - Part 11: Tests for systemic toxicity.
8. Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device, so there is no "training set" in the computational sense. The product development likely involved iterative design and testing, but not a formally defined "training set" for an algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable. (See point 8).
§ 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.