(393 days)
A 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. These gloves were tested for use with chemotherapy drugs and Fentany] Citrate per ASTM D6978-05 (Re-approved 2013) Standard Practice for assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Powder Free Black Nitrile Patient Examination Gloves, Non-Sterile, Tested for Fentanyl Resistance meet all requirements of ASTM D6319, ASTM D6978, and FDA 21 CFR 880.6250. The powder free nitrile examination glove is manufactured from nitrile, a synthetic rubber. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e. can be worn on right hand or left hand.
This document describes the premarket notification (510(k)) for the Dermagrip Powder Free Black Nitrile Patient Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant. The focus of the study is on the non-clinical performance testing of the gloves.
1. Table of Acceptance Criteria and Reported Device Performance
The device performance is compared against several standards, including ASTM D6319, ASTM D6124, ASTM D412, ASTM D3767, ASTM D5151, and ASTM D6978, as well as ISO 10993 for biocompatibility.
| Characteristic | Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Physical Properties | ASTM D412 (Vulcanized Rubber and Thermoplastic Elastomers-Tension) | Tensile Strength: Min 14.0 MPa; Ultimate Elongation: Min 400% (After Aging) | Tensile Strength: Min 14.0 MPa (Before Aging); 14MPa min (After Aging); Ultimate Elongation: Min 500% (Before Aging); 400% min (After Aging) |
| Dimensions | ASTM D3767 (Measurement of Dimensions) | Length (all sizes): Min 240 mm; Width (XS: ≤ 80 mm, S: 80 ± 10, M: 95 ± 10, L: 110 ± 10, XL: ≥ 110); Thickness (Finger: Min 0.05 mm, Palm: Min 0.05 mm, Cuff: Min 0.05 mm) | All dimensions passed, consistent with the minimum requirements. |
| Powder Free | ASTM D6124 (Residual Powder on Medical Gloves) | Less than 2 mg per glove | Less than 2 mg per glove |
| Watertight | ASTM D5151 (Detection of Holes in Medical Gloves) | Sample size: 500 pcs; Inspection level: G1; AQL: 1.5, Acceptance No. 10 | Inspection level: G1; AQL: 1.5, Found 2 (within acceptance criteria) |
| Chemotherapy Drug Permeation | ASTM D6978-05 (Re-approved 2013) (Assessment of Medical Gloves to Permeation by Chemotherapy Drugs) | Minimum breakthrough detection time for various drugs | Carmustine (BCNU): 21.2 minutes; Thiotepa: 34.6 minutes; Others (>240 minutes for Cisplatin, Cyclophosphamide, Dacarbazine, Doxorubicin Hydrochloride, Etoposide, Fluorouracil, Ifosfamide, Methotrexate, Mitomycin C, Mitoxantrone, Paclitaxel, Vincristine Sulfate) |
| Fentanyl Resistance | ASTM D6978 | Breakthrough detection time for Fentanyl Citrate Injection | No breakthrough up to 240 minutes |
| Primary Skin Irritation | ISO 10993-10:2010 (E) & Consumer Product Safety Commission Title 16. Chapter II, Part 1500 | Non Irritating | Passes (Not a primary skin irritant, PII "0") |
| Dermal Sensitization | ISO 10993-10: 2010 (E) & Consumer Product Safety Commission, Title 16, Chapter II, Part 1500.3 (c) (4) | Non Sensitization | Passes (Not a contact sensitizer) |
| Cytotoxicity | ISO 10993-5: 2009 (E) | Non Cytotoxic | Acute systemic toxicity testing performed to demonstrate safety (Different from predicate which was Non Cytotoxic). |
| Acute Systemic Toxicity | ISO 10993-11:2017 (E) | No systemic toxicity | Concluded that the product did not induce any systemic toxicity. |
2. Sample Sizes Used for the Test Set and Data Provenance
The document primarily describes non-clinical testing.
- For the watertight test, the sample size used was 500 pieces.
- Specific sample sizes for other tests like physical properties, dimensions, residual powder, and biocompatibility are not explicitly stated in quantity, but imply a representative sample was tested to meet the ASTM and ISO standards.
- The data provenance is from laboratory testing (non-clinical) conducted by the manufacturer, WRP Asia Pacific Sdn Bhd, based in Malaysia. The studies are prospective as they are testing the new device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the document describes non-clinical performance testing of medical gloves against established engineering and biological standards, not clinical studies requiring expert interpretation of medical images or patient outcomes. The "ground truth" for these tests is defined by the specific test methods and their measurable endpoints (e.g., breakthrough time, tensile strength values).
4. Adjudication Method for the Test Set
This information is not applicable as the document describes non-clinical performance testing against objective standards, not subjective assessments requiring adjudication by multiple readers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI Improvement
This information is not applicable. The device is a medical glove, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study or AI-related metrics are irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
This information is not applicable. The device is a medical glove, and no algorithm or AI component is involved.
7. The Type of Ground Truth Used
The ground truth used for these studies is based on established industry standards and regulatory requirements, including:
- ASTM standards (e.g., ASTM D412, D3767, D5151, D6124, D6978) for physical properties, dimensions, watertight integrity, residual powder, and chemical permeation.
- ISO 10993 standards for biocompatibility (primary skin irritation, dermal sensitization, cytotoxicity, acute systemic toxicity).
These standards define objective, measurable criteria for the glove's performance.
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" as this is not a machine learning or AI-based device. Performance is evaluated against pre-defined, physical, and chemical standards.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable due to the absence of a training set for this device. The "ground truth" for evaluating the glove's performance is established by the methodologies and specified outcomes mandated by the referenced ASTM and ISO standards.
§ 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.