(184 days)
Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour) is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs and Fentanyl Citrate.
These gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentany1 Citrate (Fusion Colour) is a disposable single-use, non-sterile, fusion-colored and powder-free examination glove made from nitrile latex.
The provided text is a 510(k) summary for the Biodegradable Nitrile Powder Free Examination Glove. It details the device's characteristics and compares it to a predicate device, focusing on non-clinical testing to demonstrate substantial equivalence.
Here's an analysis of the provided information regarding acceptance criteria and the study proving the device meets them, presented in the requested format.
1. Table of Acceptance Criteria and Reported Device Performance
The device is a medical glove, and its performance is evaluated against established ASTM and ISO standards for physical characteristics, chemical permeation, and biocompatibility.
| Characteristic/Parameter | Test Methodology/Standard | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|---|
| Dimensions | ASTM D6319-19 | Length (mm): XS, S: Min 220; M, L, XL: Min 230 | |
| Width (mm): XS: 70 ± 10; S: 80 ± 10; M: 95 ± 10; L: 110 ± 10; XL: 120 ± 10 | Length (mm): XS: 240; S: 242; M: 239; L: 246; XL: 245 (Meets requirements) | ||
| Width (mm): XS: 76; S: 86; M: 97; L: 107; XL: 114 (Meets requirements) | |||
| Thickness | ASTM D6319-19 | Palm: Minimum 0.05 mm | |
| Finger: Minimum 0.05 mm | Palm Thickness (mm): XS: 0.05; S: 0.05; M: 0.06; L: 0.06; XL: 0.06 (Meets requirements) | ||
| Finger Thickness (mm): XS: 0.08; S: 0.08; M: 0.08; L: 0.08; XL: 0.08 (Meets requirements) | |||
| Physical Properties | ASTM D6319-19 | Tensile Strength: Min 14 MPa (Before & After Aging) | |
| Ultimate Elongation: Min 500% (Before Aging); Min 400% (After Aging) | Before Age: Tensile Strength (MPa) Average 35; Elongation at Break (%) Average 565 (Meets requirements) | ||
| After Age: Tensile Strength (MPa) Average 36; Elongation at Break (%) Average 469 (Meets requirements) | |||
| Freedom from Holes | ASTM D5151-19, ASTM D6319-19 | AQL 2.5 (Acceptable Quality Level) | Meets ASTM D6319-19 and ASTM D5151-19 requirements of AQL 2.5. Reported as pass at AQL 1.5, which is a tighter quality level. (Meets requirements) |
| Powder Residual | ASTM D6124-06 (2017), ASTM D6319-19 | Powder Free; ≤ 2 mg per glove | Average 0.14 mg/glove (Meets requirements) |
| Chemotherapy Drugs Permeation | ASTM D6978-05 (2019) | Varies per drug; generally, high breakthrough times for most drugs, with specific values for Carmustine and Thiotepa (e.g., >240 minutes for many, as low as 12.1 for Carmustine) | Carmustine (3.3 mg/ml): 12.1 minutes |
| Thiotepa (10.0 mg/ml): 37.8 minutes | |||
| Other 21 listed drugs: > 240 minutes (Meets specified breakthrough times; noted warnings about Carmustine usability) | |||
| Fentanyl Citrate Permeation | ASTM D6978-05 (2019) | >240 minutes | >240 minutes (Meets requirements) |
| In Vitro Cytotoxicity | ISO 10993-5:2009 | Not cytotoxic | The neat extract was found to be cytotoxic. (This is a deviation from the acceptance criteria, but the device was still cleared, likely due to overall risk-benefit and other biocompatibility tests. The summary highlights this as a direct finding, not stating it "meets" the non-cytotoxic criterion.) |
| Dermal Sensitization | ISO 10993-10:2021 | Not a sensitizer | Under the conditions of the study, the device is not a sensitizer. (Meets requirements) |
| Primary Skin Irritation | ISO 10993-23:2021 | Not an irritant | Under the conditions of the study, the device is not an irritant. (Meets requirements) |
| Acute Systemic Toxicity | ISO 10993-11:2017 | No systemic toxicity concern | Under the conditions of this study, the device showed no evidence of acute systemic toxicity. (Meets requirements) |
| Shelf-Life Expiry | ASTM D7160-16 | (Not explicitly listed as an acceptance criteria in the table, but reported as a characteristic) | 3 years (Identical to predicate device) |
(Note: The discrepancy for In Vitro Cytotoxicity is explicitly stated in the document as "found to be cytotoxic" while the acceptance criteria is "not cytotoxic." This indicates the device did not meet this specific acceptance criterion, but approval was still granted, implying the FDA found other evidence or risk mitigation sufficient.)
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify the exact sample sizes (e.g., number of gloves) used for each individual test (test set). It refers to the standards used (ASTM, ISO), which inherently define the testing methodology, including sample sizes for certain evaluations. However, the specific number of units tested for each parameter in this particular study is not provided in the summary.
Data Provenance: The document does not explicitly state the country of origin of the data collectors or the testing laboratories, but the applicant is "Hartalega NGC Sdn. Bhd." located in Malaysia. The tests are non-clinical (laboratory testing of the physical device), not human subject data. The testing appears to be prospective in the sense that the tests were conducted specifically to support this 510(k) submission for this new device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This section is Not Applicable to this device and study type. The "ground truth" for this medical device (examination glove) is established through standardized, objective laboratory measurements as defined by ASTM and ISO standards for physical properties, chemical resistance, and biocompatibility. There is no human interpretative "ground truth" (e.g., expert consensus on images) involved, as there would be for an AI-based diagnostic device.
4. Adjudication Method for the Test Set
This is Not Applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving human interpretation or machine learning models where subjective assessment, diagnostic disagreement, or ground truth establishment based on expert consensus is required. The testing demonstrated here involves objective physical and chemical measurements.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
This is Not Applicable. An MRMC study assesses the performance of human readers, typically in a diagnostic setting, often with and without AI assistance. This submission describes a physical medical device (examination glove) and its non-clinical performance against established standards, not a diagnostic or AI-assisted product.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is Not Applicable. This is not an algorithm or AI product, but a physical examination glove.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is derived from:
- Standardized Test Methods and Protocols: As defined by ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards. These standards specify how to objectively measure various properties (e.g., dimensions, tensile strength, permeation time, cytotoxicity).
- Laboratory Measurements: Direct, quantitative measurements of the glove's physical, chemical, and biological interactions according to the established standard methods.
8. The Sample Size for the Training Set
This is Not Applicable. There is no "training set" as this is not an AI/ML device. The testing described is for a physical product, not a statistical model that requires training data.
9. How the Ground Truth for the Training Set was Established
This is Not Applicable as there is no training set for this 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.