(156 days)
The Nitrile Powder Free Examination Glove (Blue) with Low Dermatitis Potential Claim is a disposable device intended for Medical purpose that is worn on the examiner's hands or finger to prevent contamination patient and examiner. In addition these gloves was tested for use with Chemotherapy drugs in accordance with ASTM D6978-05 standards, Practice for assessment of medical glove to Permeation by Chemotherapy Drugs.
The subject device in this 510(k) Notification is Blue Nitrile Examination gloves, with Low Dermatitis Potential Claim and tested for use with Chemotherapy drugs. The subject device is a patient examination glove made from nitrile compound, Blue color, powder free and nonsterile (Per 21 CFR 880.6250, class I). The device meets all the specifications in ASTM D6319-10, ASTM D5151-06, ASTM D6124-06, and ASTM D6978-05 and Modified Draize 95 test.
The provided document describes the safety and performance characteristics of a Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis Potential Claim and with tested for use with Chemotherapy Drugs Claims (K181066), rather than an AI/ML powered medical device. Therefore, much of the requested information (e.g., AI/ML specific acceptance criteria, sample sizes for test/training sets, ground truth establishment methods, MRMC studies, standalone performance studies) is not applicable or available within this document.
However, I can extract and present the available information regarding the glove's acceptance criteria and the studies conducted to demonstrate its performance against those criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Product Code | LZA, LZC | LZA, LZC |
| Intended Use | A powder free 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. The device is for over-the-counter use. | A powder free 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. The device is for over-the-counter use. |
| Material Use | Nitrile compound | Nitrile compound |
| Color | Blue | Blue |
| Sterility | Non sterile | Non sterile |
| Single Use | Single used | Single used |
| Dimensions | Overall Length (mm): Min 230mm | |
| Width (± 5mm): Size S = 85mm, Size M = 95mm, Size L = 105mm, Size XL = 115mm | ||
| Thickness at Palm (mm): Min; 0.05 mm | ||
| Thickness at Finger Tip (mm): Min 0.05 mm | Min 230mm (for length, width, and thickness values are specific to the given sizes and meet min 0.05mm for Palm and Finger Tip). | |
| Physical Properties | Before Ageing: | |
| Tensile Strength (MPa) = 14min | ||
| Ultimate Elongation (%) = 500min | ||
| After Aging at 70ºC for 168 hrs @ 100℃ for 22 hrs: | ||
| Tensile Strength (MPa) = 14min | ||
| Ultimate Elongation (%) = 400min | Before aging: | |
| Tensile strength: Min 14 Mpa | ||
| Ultimate Elongation: Min 500% | ||
| After Aging: | ||
| Tensile strength: Min 14 Mpa | ||
| Ultimate Elongation: Min 400% | ||
| Freedom from pinholes | AQL 2.5, Inspection Level G-1 | Meets ASTM D5151-06 (which specifies AQL 2.5, Inspection Level G-1) |
| Residual Powder | ≤ 2.0 mg/pc | ≤ 2.0 mg/pc |
| Biological Evaluation on Medical Device - Primary Skin Irritation Test | Not explicitly stated as a numerical value, but implied to be non-irritant. | Under the conditions of this study, the test article was a non-irritant. |
| Biological Evaluation on Medical Device - Dermal Sensitization Assay | Not explicitly stated as a numerical value, but implied to be non-sensitizer. | Under the conditions of this study, the test article was a non-sensitizer. |
| ISO 10993-5:2009 Biological Evaluation of Medical Device - Part 5: Test for In Vitro Cytotoxicity | Not explicitly stated as a numerical value, but implied to be non-cytotoxic. | Under the conditions of this study, the test article was not cytotoxic. |
| Resistance against Chemotherapy Drugs (Minimum Breakthrough Detection time in minutes) | ||
| 1) Carmustine (BCNU)(3.3 mg/ml) | 12.9 min | |
| 2) Cisplatin (1.0 mg/ml) | No breakthrough up to 240 min | |
| 3) Cyclophosphamide (Cytoxan)(20 mg/ml) | No breakthrough up to 240 min | |
| 4) Dacarbazine (DTIC) (10.0 mg/ml) | No breakthrough up to 240 min | |
| 5) Doxorubicin Hydrochloride (2.0 mg/ml) | No breakthrough up to 240 min | |
| 6) Etoposide (Toposar)(20.0 mg/ml) | No breakthrough up to 240 min | |
| 7) Fluorouracil (50.0 mg/ml) | No breakthrough up to 240 min | |
| 8) Paclitaxel (Taxol)(6.0 mg/ml) | No breakthrough up to 240 min | |
| 9) Thiotepa (10.0 mg/ml) | 24.7 min | |
| Low Dermatitis Potential Claim | No clinical evidence of residual chemical additives that may induce Type IV allergy in human subjects | No Clinical evidence presence of residual chemical additives that may induce Type IV allergy in human subject |
2. Sample Sizes Used for the Test Set and Data Provenance
- Physical and Chemical Tests: The document refers to compliance with various ASTM standards (D6319-10, D5151-06, D6124-06, D6978-05). These standards prescribe specific sampling plans and test methods. The exact sample sizes used for each of these physical and chemical tests are not explicitly stated in this summary. The data provenance would be from laboratory testing according to these standards.
- Biocompatibility/Low Dermatitis Potential Claim:
- Sample Size: A total of 205 human subjects were tested for the Modified Draize-95 test. This involved an initial population of 30, with a further number added to reach 205.
- Data Provenance: The study was a prospective human subject test conducted to evaluate the potential for irritation or sensitization. The document states the subjects "reasonably reflect the general user population in the US." The country of origin of the data is not explicitly stated, but the mention of "human subjects...in the US" could imply the study was conducted there, or at least designed to reflect a US population's response.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- For the physical and chemical tests (e.g., tensile strength, pinholes, chemotherapy drug permeation), the "ground truth" is established by the direct measurement or observation of the glove's performance against the objective criteria set by the ASTM standards. No human consensus "experts" are typically involved in establishing this type of ground truth beyond the trained personnel performing the tests according to the standard operating procedures.
- For the Low Dermatitis Potential Claim, the "ground truth" was established by the clinical observations of the 205 human subjects during the Modified Draize-95 test. The document states, "The study completed on 205 non sensitized adult human subjects... gave all negative results. There was no clinical evidence of the presence of residual chemical additives that may induce Type IV allergy..." This implies clinical evaluation by medical professionals, but the number and specific qualifications of these experts are not provided in the document.
4. Adjudication Method for the Test Set
- For the physical and chemical tests, adjudication is based on whether the measured values meet the specified criteria in the ASTM standards.
- For the Low Dermatitis Potential Claim via the Modified Draize-95 test, the outcome ("all negative results," "no clinical evidence") suggests a direct observation and interpretation by clinical evaluators rather than a formal multi-reader adjudication process like 2+1 or 3+1. The methodology would follow the specified FDA guidance document referenced.
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
- Not Applicable. This document describes a medical glove, not an AI/ML powered device. Therefore, no MRMC study involving human readers with or without AI assistance was conducted or reported.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable. This document describes a medical glove, not an AI/ML powered device. Therefore, no standalone algorithm performance study was conducted or reported.
7. The Type of Ground Truth Used
- Objective Measurement/Standard Compliance: For physical properties (dimensions, tensile strength, elongation, pinholes, residual powder) and chemotherapy drug resistance, the ground truth is based on direct laboratory measurements and adherence to established ASTM standards.
- Clinical Observation: For the biocompatibility claims (primary skin irritation, dermal sensitization, cytotoxicity) and the low dermatitis potential claim, the ground truth is based on clinical observations and laboratory assays as per ISO 10993-10:2010, ISO10993-5, 16 CFR Part 1500.41, and the Modified Draize-95 test results on human subjects.
8. The Sample Size for the Training Set
- Not Applicable. This is not an AI/ML device, so there is no training set in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no AI/ML component, there is no training set or ground truth establishment for such a set.
§ 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.