(86 days)
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs.
The subject device is single use, disposable gloves intended for medical purposes to be worn on the examiner's hands to prevent contamination between patient and examiner. The gloves are powder-free, ambidextrous with beaded cuff, blue colored, nitrile, and tested for use with chemotherapy drugs. The gloves are offered in four sizes: extra-small, small, medium, large, and extra-large.
The provided document describes the FDA 510(k) premarket notification for "Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs)". This document is for a medical device (gloves), not an AI/Software as a Medical Device (SaMD). Therefore, the concepts of acceptance criteria for AI performance, training/test sets, ground truth establishment by experts, MRMC studies, standalone algorithm performance, or a sample size for training data are not applicable to this submission.
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the physical and chemical performance standards for the gloves, particularly their resistance to chemotherapy drugs and biocompatibility.
Here's the information extracted from the provided text, tailored to the context of a physical medical device:
Acceptance Criteria and Device Performance for Disposable Nitrile Powder-Free Examination Gloves
The acceptance criteria for the Disposable Nitrile Powder-Free Examination Gloves are based on compliance with established international and national standards for medical gloves, particularly regarding their physical properties, freedom from holes, residual powder content, and resistance to permeation by chemotherapy drugs.
1. Table of Acceptance Criteria and Reported Device Performance
| No. | Test Methodology / Standard | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|---|
| 1 | ISO 10993-10:2010 (Irritation & Skin Sensitization) | Assess possible contact hazards from chemicals released from medical devices (skin/mucosal irritation, eye irritation, skin sensitization). | Skin Sensitization Test: Grades less than 1, otherwise sensitization. | |
| Skin Irritation Test: Primary irritation index 0-0.4 (Negligible). | Skin Sensitization Test: All grades are 0. All animals survived with no abnormal signs. | |||
| Skin Irritation Test: Primary irritation index is 0. Response categorized as negligible. | ||||
| 2 | ISO 10993-5:2009 (In Vitro Cytotoxicity) | Assess in vitro cytotoxicity of medical devices. | Viability reduced to 240 Minutes |
- Cyclophosphamide (Cytoxan) 20.0 mg/ml: > 240 Minutes
- Dacarbazine 10 mg/ml: > 240 Minutes
- Doxorubicin 2.0 mg/ml: > 240 Minutes
- Etoposide 20.0 mg/ml: > 240 Minutes
- Fluorouracil 50.0 mg/ml: >240 Minutes
- Paclitaxel 6.0 mg/ml: >240 Minutes
- Thio Tepa 10.0 mg/ml: 46.8Minutes (min.) | Reported Breakthrough Detection Times: (Matches acceptance criteria values exactly, indicating compliance).
- Carmustine (BCNU) 3.3 mg/ml: 22.8(23.7, 22.8, 23.1) Minutes
- Cisplatin 1.0 mg/ml: > 240 Minutes
- Cyclophosphamide (Cytoxan) 20.0 mg/ml: > 240 Minutes
- Dacarbazine 10 mg/ml: > 240 Minutes
- Doxorubicin 2.0 mg/ml: > 240 Minutes
- Etoposide 20.0 mg/ml: > 240 Minutes
- Fluorouracil 50.0 mg/ml: >240 Minutes
- Paclitaxel 6.0 mg/ml: >240 Minutes
- Thio Tepa 10.0 mg/ml: 46.8(48.2, 48.6, 46.8) Minutes.
Warning: Low permeation times for Carmustine (BCNU) and Thio Tepa are noted, with a warning not to use with these specific drugs given their breakthrough times. |
2. Sample Size Used for the Test Set and Data Provenance
The document describes material and performance testing, not a "test set" in the sense of an AI model's dataset. The "samples" refer to physical gloves selected for testing.
The provenance of the data is from laboratory testing conducted on the manufactured gloves. The specific country of origin for the testing itself is not explicitly stated, but the manufacturer is Shandong Maida Medical Technology Co.,Ltd. in China. The testing is prospective in the sense that newly manufactured gloves are tested to ensure they meet the standards.
- ASTM D5151 (Detection of Holes): Sample size for water leakage test: 125 gloves.
- ASTM D6319 (Dimensions & Physical Properties): Results are shown for multiple lots (e.g., Lot no.: 210515, 210518, 210520), indicating multiple samples were tested across different manufacturing batches. The exact number of gloves per lot for each physical test (e.g., tensile strength, elongation) is not specified but would be defined by the ASTM standard.
- ASTM D6978 (Chemotherapy Permeation): The results provide triplet values for Carmustine and Thio Tepa (e.g., 22.8(23.7, 22.8, 23.1)), suggesting three independent measurements were taken for these drugs. The standard itself specifies the number of replicates.
- Biocompatibility Testing: The number of animal subjects used for the animal irritation, sensitization, and systemic toxicity tests is not specified in the summary but would conform to the respective ISO standards.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This section is not applicable as the evaluation involves standardized laboratory testing against defined physical and chemical properties, not human expert interpretation of subjective data or images. The "ground truth" is defined by the objective measurement results according to the specified ASTM and ISO standards.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods (like 2+1, 3+1) are for resolving discrepancies in human expert assessments (e.g., in medical image interpretation). Here, numerical test results from standardized methods are directly compared against established quantitative or qualitative acceptance criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This is not applicable. MRMC studies are used to evaluate diagnostic imaging systems or AI tools where human readers are involved. This submission is for a physical medical glove.
6. Standalone (Algorithm Only) Performance
This is not applicable. This concept applies to AI/software performance. The device is a physical glove, not an algorithm.
7. Type of Ground Truth Used
The ground truth used is based on objective, quantitative measurements derived from standardized laboratory tests (bench testing) and biological responses observed in validated biocompatibility assays according to international standards (ASTM and ISO). This includes:
- Quantitative Thresholds: e.g., minimum tensile strength, maximum residual powder, minimum breakthrough time for chemotherapy drugs.
- Qualitative Observations (Biological): e.g., absence of irritation or sensitization, absence of systemic toxicity.
- Conformity to Standards: The device's performance is compared directly to the specified requirements within each standard (e.g., ASTM D6319-19 dimensions, physical properties).
One point of note is the cytotoxicity result (17.1% viability) which is below the 70% threshold, indicating cytotoxicity. The document addresses this by stating: "Analysis3: The proposed device is potentially cytotoxic, but all proposed devices are conducted the systemic toxicity test." And the systemic toxicity test showed "no evidence of systemic toxicity." This implies that despite the in vitro cytotoxicity, the manufacturer argues that in vivo systemic toxicity (which is generally considered a more critical endpoint for patient safety) was not observed, suggesting the findings are acceptable for the device's intended use according to the biocompatibility evaluation framework.
8. Sample Size for the Training Set
This is not applicable. There is no "training set" in the context of a physical device. The manufacturing process is controlled to produce gloves consistently, and batch testing ensures quality.
9. How the Ground Truth for the Training Set Was Established
This is not applicable. As there is no training set, the establishment of ground truth for it is irrelevant. The manufacturing process is designed and verified to produce products meeting the specified design and performance criteria.
§ 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.