(102 days)
The Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The proposed device was tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
The proposed device, Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The proposed device is a Powder Free Nitrile Patient Examination Glove that is available in multiple sizes
The proposed device is provided non-sterile. The proposed device is made of Nitrile. The proposed device acts as a barrier.
Here's a breakdown of the acceptance criteria and study information for the Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, based on the provided FDA 510(k) submission.
1. Table of Acceptance Criteria and Reported Device Performance
The device is evaluated against specific ASTM standards for various properties and against a predicate device (K163146) for comparison. The key acceptance criteria and reported performance for critical aspects are as follows:
| Acceptance Criteria (Standard / Property) | Specific Requirement (as per standard) | Proposed Device Performance | Met Criteria? |
|---|---|---|---|
| Chemotherapy Drug Permeation | Breakthrough Detection Time: > 240 minutes for most drugs, except where noted by predicate | Varies per drug (see table below) | Met for most, not for Carmustine and Thiotepa (but disclosed) |
| Dimension (Length) | >= 230 mm (min) | 230 mm (all sizes) | Yes |
| Dimension (Width) | Varies per size (e.g., 70-120 mm) ±10 | Matches requirement | Yes |
| Dimension (Thickness - Finger) | 0.07 mm ±0.02 (for proposed) | 0.07 mm ±0.02 (specified) | Yes (meets own spec) |
| Dimension (Thickness - Palm) | 0.05 mm (min, for proposed) | 0.05 mm (specified) | Yes (meets own spec) |
| Dimension (Thickness - Cuff) | 0.05 mm ±0.02 (for proposed) | 0.05 mm ±0.02 (specified) | Yes (meets own spec) |
| Tensile Strength (Before Aging) | 15 MPa, min (ASTM D6319) | 15 MPa, min | Yes |
| Ultimate Elongation (Before Aging) | 500% min (ASTM D6319) | 500% min | Yes |
| Tensile Strength (After Aging) | 14 MPa, min (ASTM D6319) | 14 MPa, min | Yes |
| Ultimate Elongation (After Aging) | 400% min (ASTM D6319) | 400% min | Yes |
| Detection of Holes | Not detected (ASTM D5151) | Not detected | Yes |
| Powder Content | Max. 0.35 mg per glove (specified for proposed, meets ASTM D6319) | Max. 0.35 mg per glove | Yes (meets own spec) |
| Biocompatibility (Irritation) | Not an irritant (ISO 10993-10) | Not an irritant | Yes |
| Biocompatibility (Sensitization) | Not a sensitizer (ISO 10993-10) | Not a sensitizer | Yes |
| Biocompatibility (In Vitro Cytotoxicity) | Not cytotoxic (ISO 10993-5) | Not cytotoxic | Yes |
Chemotherapy Drug Permeation Performance and Acceptance Criteria (from tables on pages 2 and 5-6):
The acceptance criterion for chemotherapy drug permeation is generally a breakthrough detection time of >240 minutes, as demonstrated by most drugs. However, for Carmustine and Thiotepa, lower breakthrough times are explicitly noted and acknowledged. The device performance for these drugs is compared against the general expectation and specific values are provided.
| Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes (Reported Device Performance) | Acceptance Criteria Met? (Based on general >240 min, or specific disclosure for lower times) |
|---|---|---|---|
| Bleomycin | 15 mg/ml (15,000 ppm) | >240 | Yes |
| Busulfan | 6 mg/ml (6,000 ppm) | >240 | Yes |
| Carboplatin | 10 mg/ml (10,000ppm) | >240 | Yes |
| Carmustine (BCNU) | 3.3 mg/ml (3,300ppm) | 8.5 (12.7, 13.4, 8.5) (Noted as having low permeation time) | Yes (Disclosed and acceptable with warning) |
| Cisplatin | 1.0 mg/ml (1,000ppm) | >240 | Yes |
| Cyclophosphamide(Cytoxan) | 20.0 mg/ml (20,000ppm) | >240 | Yes |
| Cytarabine | 100 mg/ml (100,000ppm) | >240 | Yes |
| Cytovene | 10 mg/ml (10,000ppm) | >240 | Yes |
| Dacarbazine(DTIC) | 10.0 mg/ml (10,000ppm) | >240 | Yes |
| Daunorubicin | 5 mg/ml (5,000ppm) | >240 | Yes |
| Docetaxel | 10.0 mg/ml(10,000 ppm) | >240 | Yes |
| Doxorubicin Hydrochloride | 2.0 mg/ml (2,000ppm) | >240 | Yes |
| Ellence | 2 mg/ml (2,000ppm) | >240 | Yes |
| Etoposide(Toposar) | 20.0 mg/ml(20,000ppm) | >240 | Yes |
| Fludarabine | 25 mg/ml(25,000ppm) | >240 | Yes |
| Fluorouracil | 50 mg/ml(50,000ppm) | >240 | Yes |
| Gemcitabine (Gemzar) | 38 mg/ml(38,000ppm) | >240 | Yes |
| Idarubicin | 1 mg/ml (1,000ppm) | >240 | Yes |
| Ifosfamide | 50.0 mg/ml (50,000ppm) | >240 | Yes |
| Irinotecan | 20.0 mg/ml (20,000ppm) | >240 | Yes |
| Mechlorethamine HCI | 1.0 mg/ml (1,000ppm) | >240 | Yes |
| Melphalan | 5 mg/ml (5,000ppm) | >240 | Yes |
| Methotrexate | 25mg/ml (25,000ppm) | >240 | Yes |
| Mitomycin C | 0.5 mg/ml (500 ppm) | >240 | Yes |
| Mitoxantrone | 2.0 mg/ml(2,000ppm) | >240 | Yes |
| Oxaliplatin | 2.0 mg/ml(2,000ppm) | >240 | Yes |
| Paclitaxel (Taxol) | 6.0 mg/ml(6,000ppm) | >240 | Yes |
| Rituximab | 10 mg/ml(10,000ppm) | >240 | Yes |
| Thiotepa | 10.0 mg/ml (10,000ppm) | 36.1 (51.2, 36.1, 45.6) (Noted as having low permeation time) | Yes (Disclosed and acceptable with warning) |
| Trisenox | 0.1 mg/ml (100ppm) | >240 | Yes |
| Vincristine Sulfate | 1.0 mg/ml (1,000ppm) | >240 | Yes |
| Vinorelbine | 10 mg/ml(10,000ppm) | >240 | Yes |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the exact sample size for each specific test. However, it indicates that "Bench tests were conducted to verify that the proposed device met all specifications."
- Sample Size: Not explicitly stated as a numerical value for each test. The adherence to standards like ASTM D6319, ASTM D5151, ASTM D6124, ASTM D6978, ISO 2859-1, ISO 10993-10, and ISO 10993-5 implies that appropriate sample sizes, as dictated by these standards, were used for testing various properties (e.g., AQL for holes, specific number of samples for mechanical properties and chemical permeation). ISO 2859-1 specifically relates to "Sampling Procedures for Inspection by Attributes – Part I: Sampling Plans Indexed by Acceptable Quality Level (AQL) for Lot-by-Lot Inspection," indicating a quality control sampling approach for certain attributes.
- Data Provenance: The tests were non-clinical bench tests conducted to evaluate the physical, performance, and biocompatibility characteristics of the gloves. The country of origin for the manufacturing company is China (Hebei Titans Hongsen Medical Technology Co., LTD.). The submission is for a medical device (gloves), and the testing appears to be prospective in nature, conducted specifically for this 510(k) submission to demonstrate compliance with standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this submission. The device is a medical glove, and its performance is evaluated against established physical, chemical, and biological standards (ASTM and ISO). The "ground truth" here is the pass/fail criteria defined by these objective engineering and material science standards, not subjective human interpretations or expert consensus on medical images or diagnoses.
4. Adjudication Method for the Test Set
This is not applicable as the evaluation is based on objective, standardized test methods with clear pass/fail criteria, not on subjective expert review requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This is not applicable. This submission is for a medical device (gloves) and does not involve AI or human readers for diagnostic or interpretive tasks.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. This submission is not for an algorithm or AI device.
7. The Type of Ground Truth Used
The "ground truth" in this context refers to the established scientific and engineering standards and their predefined pass/fail criteria. These include:
- ASTM D6319-10: Standard Specification for Nitrile Examination Gloves for Medical Application (for dimensions, physical properties).
- 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 of Medical Gloves to Permeation by Chemotherapy Drugs (for chemical permeation).
- ISO 2859-1:1999: Sampling Procedures for Inspection by Attributes – Part I: Sampling Plans Indexed by Acceptable Quality Level (AQL) for Lot-by-Lot Inspection.
- ISO 10993-10: 2010: Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization.
- ISO 10993-5:2009: Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity.
The performance values obtained from the actual testing of the gloves are compared directly against the quantitative limits set forth in these standards.
8. The Sample Size for the Training Set
This is not applicable. The device is a physical product (gloves) and does not involve a "training set" in the context of machine learning or AI models.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason as 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.