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510(k) Data Aggregation
(53 days)
This glove is intended to be worn by operating room personnel to protect a surgical wound from contamination. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978.
The following chemicals have been tested with these gloves.
The tested chemotherapy drugs' breakthrough detection times are listed as follows:
Chemotherapy Drug Minimum BDT
Carmustine, 3.3 mg/ml 16.0 min.
Cisplatin, 1.0 mg/ml >240 min.
Cyclophosphamide (Cytoxan) , 20 mg/ml >240 min.
Doxorubicin Hydrochloride, 2.0 mg/ml >240 min.
Etoposide (Toposar) , 20.0 mg/ml >240 min.
Fluorouracil, 50.0 mg/ml >240 min.
Methotrexate, 25 mg/ml >240 min.
Paclitaxel (Taxol) , 6.0 mg/ml >240 min.
Thiotepa, 10.0 mg/ml 16.6 min.
Vincristine Sulfate, 1.0 mg/ml >>240 min
Please note that the following drugs have extremely low permeation time of less than 30 minutes. Carmustine (3.3 mg/ml) has a minimum breakthrough time of 16.0 minutes; and Thiotepa (10.0 mg/ml) has a minimum breakthrough time of 16.6 minutes. WARNING: Do not use with Carmustine and Thio-Tepa.
The subject device is single-use disposable powder-free surgical glove that is supplied sterile and made of polyisoprene. The gloves have been tested for use with chemotherapy drugs per ASTM D6978.
The provided document describes the acceptance criteria and performance data for "Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use with Chemotherapy Drugs" (K171898) compared to a predicate device, "SensiCare PI Surgical Glove" (K152428).
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature/Test | Acceptance Criteria (Predicate Device K152428 & ASTM Standards) | Reported Device Performance (Subject Device K171898) |
|---|---|---|
| Physical Properties | ||
| Dimensions - Length | Meets ASTM D3577: 270mm min. | Similar |
| Dimensions - Width | Meets ASTM D3577: 5 1/2-70±6mm, 6-76±6mm, 6 1/2-83±6mm, 7-89±6mm, 7 1/2-95±6mm, 8-102±6mm, 8 1/2-108±6mm, 9-114±6mm | Similar |
| Dimensions - Finger Thickness | Meets ASTM D3577: 0.10mm min. | Similar |
| Dimensions - Palm Thickness | Meets ASTM D3577: 0.10mm min. | Similar |
| Dimensions - Cuff Thickness | Meets ASTM D3577: 0.10mm min. | Similar |
| Before Aging - Tensile Strength | Meets ASTM D3577: 17 MPa min | Similar |
| Before Aging - Ultimate Elongation | Meets ASTM D3577: 650% min | Similar |
| Before Aging - Stress at 500% Elongation | Meets ASTM D3577: 7.0 MPa min | Similar |
| After Aging - Tensile Strength | Meets ASTM D3577: 12 MPa min | Similar |
| After Aging - Ultimate Elongation | Meets ASTM D3577: 490% min | Similar |
| Integrity | ||
| Freedom from holes | Meets 21 CFR 800.20 and ASTM D3577 when tested in accordance with ASTM D5151: Inspection Level 1, AQL 1.5 | Similar |
| Powder-Free - Residual Powder | 240 min | >240 min |
| Cyclophosphamide (Cytoxan), 20 mg/ml | >240 min | >240 min |
| Doxorubicin Hydrochloride, 2.0 mg/ml | >240 min | >240 min |
| Etoposide (Toposar), 20.0 mg/ml | >240 min | >240 min |
| Fluorouracil, 50.0 mg/ml | >240 min | >240 min |
| Methotrexate, 25 mg/ml | >240 min | >240 min |
| Paclitaxel (Taxol), 6.0 mg/ml | >240 min | >240 min |
| Thiotepa, 10.0 mg/ml | 11.6 min (predicate) | 16.6 min |
| Vincristine Sulfate, 1.0 mg/ml | >240 min | >240 min |
| Other Chemotherapy Drugs (e.g., Cytarabine, etc.)* | >240 min (for predicate, not explicitly tested for subject device in this summary) | Not explicitly stated for subject device in this summary (but overall conclusion states similarity) |
*Note: The subject device's comparison table explicitly lists only 10 chemotherapy drugs, while the predicate device listing includes an additional 5. However, the overall conclusion of substantial equivalence implies the subject device performs similarly across all relevant criteria that define the predicate. The document states a general conclusion that "The nonclinical testing performed... demonstrates that this device is as safe, as effective, and performs as well as the predicate device".
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes for the individual tests (e.g., number of gloves tested for physical properties, number of permeation tests for each chemotherapy drug).
- Test Set Sample Size: Not explicitly stated for each test.
- Data Provenance: The physical and chemical permeation testing would be conducted in a laboratory setting based on the specified ASTM and ISO standards. The manufacturer, Better Care Plastic Technology Co., Ltd., is located in China, suggesting the testing was likely conducted by or for them, potentially in China or a qualified testing facility. The data appears to be prospective as it was generated to demonstrate compliance for this specific device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This information is not applicable to this type of device. The "ground truth" for surgical gloves and chemotherapy drug permeation is established through validated, standardized laboratory test methods (e.g., ASTM, ISO standards), not through expert consensus or clinical assessment in the same way an AI diagnostic imaging device would have. The "experts" in this context would be the technicians and scientists performing the tests according to the standard protocols.
4. Adjudication Method for the Test Set:
This information is not applicable. Adjudication methods are typically used in studies involving human interpretation or clinical endpoints. For laboratory performance testing of physical properties and chemical resistance, the results are quantitative measurements against predefined criteria in the standards.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
No. A MRMC comparative effectiveness study is not applicable to this type of medical device. This is a study design used for diagnostic devices, particularly in imaging, to assess reader performance with and without AI assistance. This document describes laboratory performance testing of a physical barrier device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
No. This is not an algorithm or AI device. It's a physical medical device (surgical gloves). The performance tested relates to its physical and chemical barrier properties in a standalone manner (i.e., the glove itself, not with human interaction beyond wearing it).
7. The type of ground truth used:
The "ground truth" for this device's performance is established by objective measurements and validated test methods specified in international standards such as:
- ASTM D3577 (Standard Specification for Rubber Surgical Gloves)
- ASTM D5151 (Standard Test Method for Detection of Holes in Medical Gloves)
- ASTM D6124 (Standard Test Method for Residual Powder on Medical Gloves)
- ASTM D6978 (Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs)
- ISO 10993 series (Biological evaluation of medical devices)
This is a form of objective laboratory data compliant with recognized standards.
8. The sample size for the training set:
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. As above, no training set is relevant for this device.
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(76 days)
This surgeon's glove is a sterile and single use device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination.
The subject device is single-use disposable powder-free surgical glove that is supplied sterile and made of polyisoprene.
The provided text is for a 510(k) premarket notification for Sterile Polyisoprene Powder Free Surgical Gloves and details the device's technical characteristics and substantial equivalence to a predicate device, rather than a study proving performance against acceptance criteria in the context of an AI/medical imaging device. Therefore, many of the requested categories for AI/medical imaging studies are not applicable.
However, I can extract the acceptance criteria and the device's reported performance from the document.
1. Table of Acceptance Criteria and Reported Device Performance
| Technological Characteristics | Acceptance Criteria (Standard/Test/Guidance) | Reported Device Performance (Result Summary) |
|---|---|---|
| Dimensions | ASTM D3577-09(2015) requirements for length, width, and thickness | Meets ASTM D3577 requirements for length, width and thickness |
| - Length | Minimum 265mm | Average 305mm |
| - Palm Width (size 5½) | 70mm | 73mm |
| - Palm Width (size 6) | 76mm | 79mm |
| - Palm Width (size 6½) | 83mm | 86mm |
| - Palm Width (size 7) | 89mm | 91mm |
| - Palm Width (size 7½) | 95mm | 97mm |
| - Palm Width (size 8) | 102mm | 105mm |
| - Palm Width (size 8½) | 108mm | 111mm |
| - Palm Width (size 9) | 114mm | 117mm |
| - Thickness (Finger) | Minimum 0.10mm | 0.22mm |
| - Thickness (Palm) | Minimum 0.10mm | 0.20mm |
| - Thickness (Cuff) | Minimum 0.10mm | 0.18mm |
| Physical Properties | ASTM D3577-09(2015) requirements for tensile strength and elongation at break before and after accelerated aging | Meets ASTM D3577-09(2015) requirements for tensile strength and elongation at break before and after accelerated aging |
| - Tensile Strength, Before Aging | 17MPa, min | Average 19.4MPa |
| - Ultimate Elongation, Before Aging | 650%, min | Average 823% |
| - Stress at 500% Elongation | 7.0 MPa, max | Average 2.2MPa |
| - Tensile Strength, After Accelerated Aging | 12MPa, min | Average 17.1 MPa |
| - Ultimate Elongation, After Accelerated Aging | 490%, min | Average 748% |
| Freedom from holes | ASTM D3577-09(2015) and ASTM D5151-06(2015) requirements of AQL 1.5 | Meets ASTM D3577-09(2015) and ASTMD5151-06(2015) requirements of AQL 1.5 |
| Powder-Free | ASTM D3577-09(2015) and ASTM D6124-06(2011) - ≤ 2 mg per glove | Meets Applicable requirement for Powder Free; ≤ 2 mg per glove |
| Sterility | ANSI/AAMI/ISO 11137-1:2006 requirement of 10-6 SAL | Meets ANSI/AAMI/ISO 11137-1:2006 requirement of 10-6 SAL |
| Biocompatibility (Skin Irritation) | ISO 10993-10:2010 | Under the conditions of the study, not an irritant |
| Biocompatibility (Maximization Sensitization) | ISO 10993-10:2010 | Under the conditions of the study, not a sensitizer |
Regarding the other requested information (primarily for AI/medical imaging studies):
- 2. Sample sized used for the test set and the data provenance: Not applicable. This document describes testing for physical and biological properties of surgical gloves, not an AI model. The tests refer to ASTM and ISO standards, which define the testing methodologies and sample sizes for those specific tests.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood in AI/medical imaging (e.g., expert consensus on image findings) is not relevant here. The "ground truth" for the glove's performance is adherence to established engineering and biocompatibility standards.
- 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This refers to consensus methods for expert reviewers, which is not relevant for this type of device testing.
- 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 is not an AI device.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For this device, the "ground truth" is defined by the objective performance specified in the referenced ASTM and ISO standards (e.g., a specific tensile strength value, freedom from holes at a certain AQL).
- 8. The sample size for the training set: Not applicable. This is not an AI device.
- 9. How the ground truth for the training set was established: Not applicable. This is not an AI device.
Key takeaway from the document: The device demonstrates compliance with recognized national and international standards (ASTM and ISO) for surgical gloves. The "study" proving the device meets the acceptance criteria consists of various material, physical, and biological tests conducted according to these standards, with the results compared directly to the specified requirements within those standards. A clinical study was explicitly stated as not conducted for either the subject or predicate devices.
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