(112 days)
Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid is a disposable device intended for medical purposes that are worn on the examiner's hand or finger to prevent contamination between patient and examiner. It is for over-the-counter use.
In addition, these gloves were tested for use with Chemotherapy drugs, Fentanyl, and Gastric Acid 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 Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid. The subject device is a patient examination glove made from nitrile latex compound, Blue color, powder-free, and non-sterile (Per 21 CFR 880.6250, class I) and come in eight sizes (XXS, XS, S, M, L, XL, and XXL). The device meets all the specifications in ASTM D6319-19, the Standard Specification for Nitrile Examination Gloves and Modified Draize Test. Additionally, the gloves have been tested for biocompatibility and permeability to chemotherapy drugs, fentanyl, and Gastric Acid.
The provided document is a 510(k) Premarket Notification for a medical device: "Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid."
The document details the technical characteristics and performance of the device through various tests, often comparing it to predicate devices. It describes the acceptance criteria and study results primarily for the physical and chemical resistance properties of the gloves, as well as biocompatibility testing.
However, it's crucial to note that this document DOES NOT describe a study involving an AI or algorithm-driven device (e.g., for image analysis or disease detection). Therefore, many of the specific questions about human readers, AI assistance, ground truth establishment for AI training, and expert adjudication are not applicable to this type of device and study.
The study described is a non-clinical performance and chemical permeation study of a physical medical device (gloves), not an AI/ML-driven diagnostic or therapeutic system.
Given this, I will describe the acceptance criteria and the study that proves the device meets them based only on the information available in the provided document, acknowledging the non-applicability of AI/ML-specific questions.
Acceptance Criteria and Device Performance for Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid (K233560)
1. Table of Acceptance Criteria and Reported Device Performance
The device performance is assessed against recognized ASTM and ISO standards for medical gloves, primarily focusing on physical properties, freedom from defects, biocompatibility, and resistance to chemical permeation.
| Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Physical Properties | ||
| Freedom from Pinholes (ASTM D5151-19) | AQL 2.5 Inspection Level G-1 | Passes AQL 1.5 Inspection Level: G1 |
| Physical Dimensions (ASTM D6319-19) | Length (min): XXS: Not indicated, XS: 220mm, S: 220mm, M: 230mm, L: 230mm, XL: 230mm, XXL: 230mm | |
| Width (± 10mm): XXS: Not indicated, XS: 70mm, S: 80mm, M: 95mm, L: 110mm, XL: 120mm, XXL: 130mm | ||
| Thickness (min): Palm: 0.05mm, Finger Tip: 0.05mm | ||
| (ISO 2859-1/S2/AQL 4.0 for dimensions) | Length (min): XXS: 220mm, XS: 220mm, S: 220mm, M: 230mm, L: 230mm, XL: 230mm, XXL: 230mm | |
| Width (± 10mm): XXS: 65mm, XS: 70mm, S: 80mm, M: 95mm, L: 110mm, XL: 120mm, XXL: 130mm | ||
| Thickness (min): Palm: 0.05mm, Finger Tip: 0.05mm | ||
| (All dimensions met according to ASTM D6319-19 and physical dimensions pass acceptance criteria.) | ||
| Tensile Strength & Elongation (ASTM D6319-19, D412-16) | Before Ageing: Tensile Strength (MPa) = 14 MPa min, Ultimate Elongation (%) = 500 min | |
| After Aging: Tensile Strength (MPa) = 14 MPa min @ 70°C for 168 hrs / 100°C for 22 hrs, Ultimate Elongation (%) = 400 min @ 70°C for 168 hrs / 100°C for 22 hrs | Pass (Meets all specified tensile strength and elongation criteria before and after ageing.) | |
| Residual Powder (ASTM D6124-06) | ≤ 2.0 mg/glove | Pass (≤ 2 mg/glove) |
| Biocompatibility (ISO 10993 series) | ||
| Acute Systemic Toxicity (ISO 10993-11) | Under the conditions of this study, the test article does not induce acute systemic toxicity. | Under the conditions of this study, the test article did not induce acute systemic toxicity. |
| Dermal Sensitization (ISO 10993-10: 2021) | Under the conditions of the study, the device is not a sensitizer. | Under the conditions of this study, the test article was a non-sensitizer. |
| Primary Skin Irritation (ISO 10993-23:2021) | Under the conditions of the study, the device is not an irritant. | Under the conditions of this study, the test article was a non-irritant. |
| Low Dermatitis Potential claim (Modified Draize 95 Test) | No clinical evidence of the presence of residual chemical additives that may induce type IV allergy in human subject. | There was no clinical evidence of the presence of residual chemical additives at the level that may induce type IV allergy in the un-sensitized general user population in the test articles. |
| Chemical Permeation (ASTM D6978-05) | Minimum Breakthrough Detection Time (minutes): Generally >240 minutes for most drugs. Specific values for Carmustine (3.3mg/ml) and Thiotepa (10ug/ml) are 22.0 minutes and 34.2 minutes respectively. The maximum testing time is 240 minutes. | Minimum Breakthrough Detection Time (minutes): Achieved >240 minutes for 40 of 42 chemotherapy drugs and all 5 other tested chemicals/acids (Cytovene, Retrovir, Triclosan, Fentanyl Citrate, Simulated Gastric Acid). Carmustine (3.3mg/ml) was 22.0 minutes. Thiotepa (10ug/ml) was 34.2 minutes. |
2. Sample Size Used for the Test Set and Data Provenance
- Physical and Chemical Resistance Tests: The document does not specify the exact sample sizes for each physical or chemical permeation test. However, these tests are generally performed on a sufficient number of glove samples to meet the requirements of the specified ASTM standards (e.g., ASTM D5151 for pinholes usually involves a large number of gloves for AQL testing).
- Biocompatibility / Modified Draize-95 Test (Low Dermatitis Potential Claim):
- Sample Size: 211 subjects initially recruited, with 205 subjects completing the two stages of the study (6 subjects discontinued due to poor compliance).
- Data Provenance: Not explicitly stated (e.g., country of origin), but the study was performed to support a 510(k) submission to the FDA for sale in the US market. Given the manufacturer is based in Malaysia (Eco Medi Glove Sdn. Bhd.), it is plausible the study was conducted there or in a region with compatible regulatory standards.
- Retrospective or Prospective: This was a prospective clinical study (Modified Draize-95 Test) specifically conducted to evaluate the low dermatitis potential of the device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- For physical and chemical resistance tests: Ground truth is established by objective, standardized laboratory measurements based on ASTM and ISO methods. No human "experts" in the sense of adjudicating medical images or clinical outcomes are involved in establishing ground truth for these types of tests.
- For the Modified Draize-95 Test: The ground truth for skin sensitization (type IV allergy) or irritation is based on the clinical observation of the subjects' skin reactions by qualified personnel (e.g., dermatologists or trained clinical researchers) following the specified protocol (FDA's guidance document "Guidance for Industry and FDA Reviewers/Staff: Premarket Notification [510k] Submissions for Testing Skin Sensitization Chemicals in Natural Rubber Products" (1999) which pertains to the Modified Draize-95 Test). The document does not specify the number or specific qualifications of these observers, but it is implied they are clinical professionals capable of evaluating skin reactions.
4. Adjudication Method for the Test Set
- For physical and chemical resistance tests: No adjudication is typically needed as tests are objective measurements against defined thresholds.
- For the Modified Draize-95 Test: The nature of the Modified Draize test involves direct clinical observation for skin reactions. While not explicitly stated as "adjudication," the interpretation of skin reactions by the clinical team would constitute the "ground truth." There is no indication of multiple independent readers or complex adjudication schemes like 2+1 or 3+1 as would be seen for subjective image interpretation.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done
- No, an MRMC comparative effectiveness study was NOT done. This type of study (comparing human readers with and without AI assistance on medical cases) is relevant for AI-powered diagnostic devices, not for physical medical devices like examination gloves.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. There is no algorithm or AI component to this device. The performance is the intrinsic material performance of the glove itself.
7. The Type of Ground Truth Used
- For physical properties: Measurement against engineering specifications and industry standards (e.g., freedom from pinholes, dimensions, tensile strength).
- For chemical permeation: Objective measurement of breakthrough time using standardized chemical testing methods (ASTM D6978-05).
- For biocompatibility (dermal irritation/sensitization): Clinical observation of human subjects for skin reactions following a standardized protocol (Modified Draize-95 Test) and in-vitro/in-vivo biological evaluations per ISO 10993. The "ground truth" is the observed biological response or lack thereof.
8. The Sample Size for the Training Set
- Not applicable. This device is a physical product and does not involve AI/ML models that require a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no AI/ML component, there is no training set or ground truth establishment for a training set.
§ 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.