(65 days)
A Powder Free Nitrile Patient Examination Glove is a dispoable device intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants. In addition, these gloves are worn to protect against exposure to some chemotherapy drugs.
The Powder Free Nitrile Patient Examination Glove, Blue Colored Non-Sterile (Low Dermatitis Potential and Chemotherapy Drug Protection Labeling Claim) will meet all the current specification for ASTM D 6319-00a83
The Perusahaan Getah Asas Sdn. Bhd. Powder Free Nitrile Patient Examination Glove, Blue Colored Non-Sterile (Low Dermatitis Potential and Chemotherapy Drug Protection Labeling Claim) demonstrates compliance with established acceptance criteria through a series of tests as detailed in the provided 510(k) submission.
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Acceptance Criteria (Standards) | Reported Device Performance |
|---|---|---|
| Dimensions | ASTM D 6319-00aε,3 | Meets |
| Physical Properties | ASTM D 412-98 | Meets |
| Freedom from pin-holes | ASTM D 5151-99 | Meets |
| Powder Free Residue | ASTM D 6124-01 | Meets |
| Biocompatibility (Dermal Sensitization) | Dermal Sensitization (as per ASTM F-720-81) | Not a contact skin sensitizer |
| Biocompatibility (Primary Skin Irritation) | Primary Skin Irritation Test (as per 16 CFR Part 1500) | Not a primary skin irritant |
| Biocompatibility (Cytotoxicity) | Cytotoxicity Test (as per ISO 10993-5) | Non cytotoxic |
| Low Dermatitis Potential | Modified Draize Test | Did not induce clinically significant skin irritation nor show any evidence of induced allergic contact dermatitis in human subjects. |
| Chemotherapy Drugs Permeation Test | ASTM F 739 (average normalized breakthrough time in minutes) | Carmustine (3.3 mg/mL): 137 min |
| Cisplatin (1.0 mg/mL): >240 min | ||
| Cyclophosphamide (20.0 mg/mL): >240 min | ||
| Dacarbazine (DTIC) (10.0 mg/mL): >240 min | ||
| Doxorubicin Hydrochloride (2.0 mg/mL): >240 min | ||
| 5-Fluorouracil (50.0 mg/mL): >240 min | ||
| Etoposide (20.0 mg/mL): >240 min | ||
| Paclitaxel (Taxol) (6.0 mg/mL): >240 min | ||
| Thio-Tepa (10.0 mg/mL): >240 min |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the specific sample sizes for each individual test conducted to demonstrate device performance. However, the data provenance is implied to be from testing conducted by or for Perusahaan Getah Asas Sdn. Bhd., a company located in Malaysia. The studies are all retrospective in the sense that the data is presented post-hoc to demonstrate compliance with pre-defined standards. The data itself would have been generated through prospective experimental testing in a laboratory or clinical setting (e.g., the Modified Draize Test would involve human subjects in a prospective manner).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
For the most part, the "ground truth" for the performance tests (e.g., dimensions, physical properties, freedom from pin-holes, powder-free residue, chemotherapy drug permeation) is established by standardized laboratory methods and instrumentation, not by human expert consensus in the way a medical image interpretation might be. These are objective measurements against established ASTM and ISO standards.
For Biocompatibility tests (Dermal Sensitization, Primary Skin Irritation, Cytotoxicity, and the Modified Draize Test for Low Dermatitis Potential), experts would have been involved in the design, execution, and interpretation of these studies. However, the exact number and qualifications of these experts (e.g., toxicologists, dermatologists, clinical researchers) are not specified in the provided document. The Modified Draize test, by its nature, would typically involve at least one qualified dermatologist or clinician to assess skin reactions.
4. Adjudication Method for the Test Set:
For the physical and chemical property tests, adjudication is not typically applicable in the same way as for medical image interpretation or clinical trials involving subjective assessment. The results are generally objective measurements against established thresholds according to the given standards.
For the biocompatibility and low dermatitis potential tests, if multiple assessors were involved in evaluating skin reactions in the Modified Draize Test, their findings would likely be subject to an adjudication process to reach a consensus, but the document does not specify any adjudication method. It only states the conclusive finding ("Did not induce clinically significant skin irritation nor show any evidence of induced allergic contact dermatitis in human subjects.").
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically relevant for diagnostic imaging devices where human readers interpret medical images with and without AI assistance. This device is a patient examination glove, and its performance is evaluated through physical, mechanical, and biological properties, not through human interpretation of cases.
6. Standalone (Algorithm Only) Performance:
Not applicable. This device is a physical product (a glove), not an algorithm or AI system. Therefore, the concept of "standalone (algorithm only) performance" does not apply. The device's performance is inherently "standalone" in the sense that it is measured directly without human-in-the-loop interpretation.
7. Type of Ground Truth Used:
The ground truth for most of the performance criteria (dimensions, physical properties, pin-holes, powder residue) is based on objective measurements against publicly recognized and established industry standards (ASTM, ISO, CFR).
For biocompatibility and low dermatitis potential, the ground truth is established through experimental results from standardized in-vitro and in-vivo tests designed to assess biological responses, with clinical observations (for the Modified Draize Test) serving as the ultimate verification of safety for skin contact.
8. Sample Size for the Training Set:
Not applicable. This device is a physical product, not an AI or machine learning model. Therefore, there is no "training set" in the context of algorithm development. The manufacturing process and quality control would involve ongoing testing, but this is not analogous to an AI training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of 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.