(129 days)
The Gen 2 Nitrile 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 claiming, this product contains 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 non-sterile (Per 21 CFR 880.6250, class I). The device meets all the specifications in ASTM D6319-10, Standard specification for Nitrile Examination Gloves.
The provided text is related to the FDA 510(k) premarket notification for a medical device: "GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for use with Chemotherapy Drugs Claims." It outlines the device's characteristics, intended use, and the tests performed to demonstrate its safety and effectiveness.
Here's an analysis of the acceptance criteria and the studies mentioned, structured as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| General Physical Properties (ASTM D6319-10) | ||
| Overall Length (mm) | Min 230mm | Meets ASTM D6319-10 (Implies compliance with length requirements) |
| Width (±5mm) | Size S= 85mm, Size M= 95mm, Size L= 105mm, Size XL= 115mm | Meets ASTM D6319-10 (Implies compliance with width requirements) |
| Thickness at Palm (mm) | Min 0.05 mm | Meets ASTM D6319-10 (Implies compliance with palm thickness requirements) |
| Thickness at Finger Tip (mm) | Min 0.05 mm | Meets ASTM D6319-10 (Implies compliance with fingertip thickness requirements) |
| Tensile Strength (MPa) - Before Ageing | 14 min | 14 min (Explicitly stated in Section 7.2) / Meets ASTM D6319-10 |
| Ultimate Elongation (%) - Before Ageing | 500 min | 500 min (Explicitly stated in Section 7.2) / Meets ASTM D6319-10 |
| Tensile Strength (MPa) - After Aging | 14 min | 14 min (Explicitly stated in Section 7.2) / Meets ASTM D6319-10 |
| Ultimate Elongation (%) - After Aging | 400 min | 400 min (Explicitly stated in Section 7.2) / Meets ASTM D6319-10 |
| Freedom from Holes (ASTM D5151-06) | ||
| Pin-hole Level | AQL 2.5, Inspection Level G-1 | AQL 2.5, Inspection Level G-1 (Explicitly stated in Section 7.2) / Meets ASTM D5151-06 |
| Powder-free residue (ASTM D6124-06) | ||
| Residual Powder | ≤ 2.0 mg/glove | Meets ASTM D6124-06 (Implies compliance) |
| Biocompatibility (ISO 10993-10, ISO 10993-5) | ||
| Primary Skin Irritation | The test article was a non-irritant. | Test article is non-irritant |
| Dermal Sensitization | The test article was a non-sensitizer. | Test article is non-sensitizer |
| In vitro Cytotoxicity | The test article was not cytotoxic. | The test article was not cytotoxic (Stated in Section 9.0 Summary) |
| Resistance against Chemotherapy Drugs (ASTM D6978-05) | ||
| Carmustine (3.3mg/ml) | 22 min breakthrough | 22 min breakthrough |
| Cisplatin (1.0mg/ml) | No breakthrough up to 240 min | No breakthrough up to 240 min |
| Cyclophosphamide (20mg/ml) | No breakthrough up to 240 min | No breakthrough up to 240 min |
| Methotrexate (25mg/ml) | No breakthrough up to 240 min | No breakthrough up to 240 min |
| Doxorubicin HCl (2.0mg/ml) | No breakthrough up to 240 min | No breakthrough up to 240 min |
| Etoposide (20.0mg/ml) | No breakthrough up to 240 min | No breakthrough up to 240 min |
| Fluorouracil (50.0mg/ml) | No breakthrough up to 240 min | No breakthrough up to 240 min |
| Paclitaxel (6.0mg/ml) | No breakthrough up to 240 min | No breakthrough up to 240 min |
| Thiotepa (10.0mg/ml) | 47.4 min breakthrough | 47.4 min breakthrough |
| Low Dermatitis Potential Claim | ||
| Modified Draize 95 test | No clinical evidence of residual chemical additives that may induce Type IV allergy in human subjects | Test article did not induce type IV allergy to human; 205 non-sensitized adult human subjects gave all negative results. |
2. Sample Size Used for the Test Set and the Data Provenance
-
Low Dermatitis Potential Claim (Clinical Study):
- Sample Size:
- Stage 1: 30 human subjects
- Stage 2 (Total): Minimum 205 individuals (including the initial 30). The study was completed on 205 adult human subjects.
- Data Provenance: The document states the subjects "reasonably reflect the general user population in the US." No explicit country of origin for the data collection is specified beyond this, but the company is in Malaysia, suggesting the study might have been conducted there or in the US with a US-representative population. The study is prospective, as it involves human testing for irritation and sensitization.
- Sample Size:
-
Chemotherapy Drug Permeation and other ASTM/ISO tests: The document does not specify the sample size for these non-clinical tests. These tests are typically conducted on a representative number of glove samples according to the respective standard (e.g., a batch of gloves). The data provenance is industrial testing, likely from the manufacturer's quality control processes in Malaysia, as it refers to meeting ASTM standards rather than specific patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- For the clinical study (Low Dermatitis Potential Claim): The document does not explicitly state the "number of experts" or their specific "qualifications" involved in establishing the ground truth of skin irritation/sensitization. The ground truth would be based on the clinical observations of the human subjects by qualified medical professionals conducting the Modified Draize 95 test.
- For non-clinical tests (ASTM/ISO): Ground truth is established by the test methods specified in the standards themselves, not typically by human experts reviewing individual cases. The results are quantitative measurements against defined criteria.
4. Adjudication Method for the Test Set
- For the clinical study (Low Dermatitis Potential Claim): The document does not specify an adjudication method like 2+1 or 3+1. The results are presented as direct observations ("all negative results," "no clinical evidence of... Type IV allergy"). This suggests direct observation and interpretation by the clinicians conducting the study.
- For non-clinical tests: Adjudication methods like those for interpreting medical images are not applicable here. The tests involve direct measurement against a standard.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This device is a nitrile examination glove, not an AI-powered diagnostic algorithm or imaging device that would typically involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This refers to a standalone performance study of the device itself.
- Yes, for the physical and chemical properties: The ASTM and ISO standard tests (e.g., tensile strength, pinholes, chemotherapy drug permeation, biocompatibility) are standalone evaluations of the glove material and design performance. They are conducted without human intervention in the loop other than performing the test itself.
- Yes, for the clinical dermatological claim: The Modified Draize 95 Test is a standalone assessment of the glove's potential to cause skin irritation or sensitization on human subjects.
7. The Type of Ground Truth Used
- Low Dermatitis Potential Claim: Clinical observation / Outcomes data (absence of irritation/sensitization in human subjects after exposure).
- Chemotherapy Drug Resistance: Laboratory measurement against established permeation thresholds (quantitative data defined by ASTM D6978-05).
- Physical Properties (Tensile Strength, Elongation, Dimensions, Pin-holes): Laboratory measurement against specified physical standards (quantitative data defined by ASTM D6319-10 and ASTM D5151-06).
- Powder-free Residue: Laboratory measurement (quantitative data defined by ASTM D6124-06).
- Biocompatibility (Cytotoxicity): Laboratory measurement (quantitative or qualitative data defined by ISO 10993-5).
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable here as this is not an AI/machine learning device. The studies described are for validation/testing of the final product.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of medical 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.