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510(k) Data Aggregation
(203 days)
Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs
This device is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
The tested chemotherapy drugs are as follows:
- Carmustine (BCNU) 3.3 mg/mL Cisplatin 1.0 mg/mL Cyclophosphamide (Cytoxan) 20 mg/mL Dacarbazine (DTIC) 10.0 mg/mL Doxorubicin Hydrochloride 2.0 mg/mL Etoposide (Toposar) 20.0 mg/mL Fluorouracil 50.0 mg/mL Methotrexate 25 mg/mL Paclitaxel (Taxol) 6.0 mg/mL Thiotepa 10.0 mg/mL Vincristine Sulfate 1.0 mg/mL
Note that Carmustine(BCNU) and Thiotepa have low permeation times.
Fentayl tested as follows: Fentanyl citrate 100 mcg/2mL
Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs.
This document describes a 510(k) premarket notification for a non-sterile, powder-free nitrile examination glove. It focuses on demonstrating substantial equivalence to a predicate device. The information provided is primarily related to the physical and chemical properties of the gloves, and their performance against established ASTM and ISO standards for medical gloves, rather than a diagnostic AI device requiring a clinical study with ground truth.
Given the nature of the device (medical gloves), the request for acceptance criteria and a study proving device meets acceptance criteria in the context of an AI device with ground truth, multi-reader studies, and training sets is not directly applicable. However, I can extract and present the relevant information from the document as it pertains to the performance criteria and testing used for these gloves.
1. A table of acceptance criteria and the reported device performance
The document provides a comparison table between the predicate device (K083755) and the subject device (K182241) against various technical characteristics and standards. It implicitly uses the standards as acceptance criteria.
| Technological Characteristic | Standard (Acceptance Criteria) | Reported Subject Device Performance (K182241) |
|---|---|---|
| Indications for Use | (As described in regulatory text) | "Nearly Identical" to predicate |
| Dimensions: overall length | Minimum 230 mm (ASTM-D 6319) | 238 mm (for all 3 measurements provided) |
| Dimensions: width (mean) | 110 ± 10 mm (ASTM-D 6319) | Size Large: 114 mm, 115 mm, 114 mm |
| Dimensions: palm and finger thickness | Minimum 0.05 mm (ASTM-D 6319) | Palm: 0.07 mm, 0.07 mm, 0.07 mm; Finger: 0.08 mm, 0.08 mm, 0.09 mm |
| Tensile strength: before and after aging | Greater than 14 MPa (ASTM-D 6319) | Before: 35 MPa, 33 MPa, 35 MPa; After: 31 MPa, 32 MPa, 34 MPa |
| Ultimate elongation: before and after aging | Greater than 500% Before, 400% After (ASTM-D 6319) | Before: 538%, 534%, 535%; After: 518%, 493%, 503% |
| Freedom from holes: pinholes AQL 2.5 | Inspection G1, AQL 2.5 (7 Accept, 8 Reject) (ASTM-D 6319) | 0, 2, 0 (number of holes found, all within AQL) |
| Powder Free Residue | 0.5 mg/glove (ASTM-D 6319) | 0.8 mg/glove, 0.8 mg/glove |
| Biocompatibility: In vitro cytotoxicity | ISO 10993-5 (No specific numerical criterion, qualitative result expected) | Device extract found cytotoxic (further evaluated by ISO 10993-11) |
| Biocompatibility: Systemic toxicity | ISO 10993-11 (No specific numerical criterion, qualitative result expected) | Device extracts did not elicit a systemic response in the animal model. |
| Biocompatibility: Primary Skin Irritation | ISO 10993-10 (No specific numerical criterion, qualitative result expected) | Polar and non-polar device extracts found not to be an irritant. |
| Biocompatibility: Sensitization | Guinea Pig Sensitization (ISO 10993-10) (No specific numerical criterion, qualitative result expected) | Polar and non-polar device extracts found not to be sensitizers. |
| Chemotherapy Drug Permeation | Permeation resistance to specified chemotherapy drugs (ASTM D6978) | Tested against 11 chemotherapy drugs (including Carmustine and Thiotepa with low permeation times), and Fentanyl. Specific permeation times are not provided in this summary, but the device is "Tested for use with Chemotherapy Drugs," implying it met relevant performance for these. |
2. Sample sized used for the test set and the data provenance
The document does not specify the exact sample sizes used for each test (e.g., number of gloves tested for dimensions, tensile strength, or holes). It refers to standards like ASTM D6319 and ISO 2859 (Sampling Procedures and Tables for Inspection by Attributes), which would dictate the sample sizes and sampling methods used for such material tests.
The data provenance is from non-clinical tests performed to demonstrate that the proposed device met all design specifications. The country of origin of the data is not explicitly stated, but the manufacturer is Sri Trang Gloves (Thailand) Co., LTD. Given the nature of manufacturing quality control and standard testing, this data would be considered prospective for the purpose of validating the product before its market release.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to the device described. The device is a medical glove, and its performance is evaluated against engineering and biological compatibility standards, not by experts establishing a "ground truth" for a diagnostic task. The tests are objective measurements and standardized biological assays.
4. Adjudication method for the test set
Not applicable. Performance is measured against objective standards, not subjective assessments requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a medical glove, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a medical glove, not an algorithm.
7. The type of ground truth used
For the physical and chemical properties, the "ground truth" is defined by the specific parameters and limits set forth in the referenced ASTM and ISO standards (e.g., minimum length, minimum tensile strength, maximum number of holes at a given AQL). For biocompatibility, the "ground truth" is the qualitative assessment of biological response (e.g., non-irritant, non-sensitizer, no systemic toxicity) in accordance with ISO 10993 series, using defined animal models and in vitro tests.
8. The sample size for the training set
Not applicable. This device is a medical glove, not an AI model that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
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