(97 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 or fingers 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: small, medium, large, and extra-large.
This is a 510(k) premarket notification for Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs. This document does not describe the acceptance criteria and study for an AI/ML device. Instead, it focuses on the performance characteristics of medical gloves, particularly their resistance to chemotherapy drugs.
Here’s a breakdown of the information provided, re-interpreting some fields for a non-AI/ML medical device where applicable, and highlighting what is missing in the context of your request for an AI/ML device:
1. A table of acceptance criteria and the reported device performance
The document provides several tables detailing the performance of the gloves.
Permeation by Chemotherapy Drugs (Key Performance Claim):
| Chemotherapy Drug | Concentration | Acceptance Criteria (Implicit, typically > the reported time for predicate or a set standard, often 240 mins) | Reported Device Performance (Breakthrough Detection Time in Minutes) |
|---|---|---|---|
| Carboplatin | 10.0 mg/ml (10,000 ppm) | N/A (Standard would be based on predicate/ASTM D6978) | > 240 Minutes |
| Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | N/A (Standard would be based on predicate/ASTM D6978) | 16.4 Minutes |
| Cisplatin | 1.0 mg/ml (1,000 ppm) | N/A (Standard would be based on predicate/ASTM D6978) | > 240 Minutes |
| Cyclophosphamide (Cytoxan) | 20.0 mg/ml (20,000 ppm) | N/A (Standard would be based on predicate/ASTM D6978) | > 240 Minutes |
| Dacarbazine | 10.0 mg/ml (10,000 ppm) | N/A (Standard would be based on predicate/ASTM D6978) | > 240 Minutes |
| Docetaxel | 10.0 mg/ml (10,000 ppm) | N/A (Standard would be based on predicate/ASTM D6978) | > 240 Minutes |
| Doxorubicin HCI | 2.0 mg/ml (2,000 ppm) | N/A (Standard would be based on predicate/ASTM D6978) | > 240 Minutes |
| Epirubicin HCI | 2.0 mg/ml (2,000 ppm) | N/A (Standard would be based on predicate/ASTM D6978) | > 240 Minutes |
| Etoposide | 20.0 mg/ml (20,000 ppm) | N/A (Standard would be based on predicate/ASTM D6978) | > 240 Minutes |
| Fluorouracil | 50.0 mg/ml (50,000 ppm) | N/A (Standard would be based on predicate/ASTM D6978) | > 240 Minutes |
| Gemcitabine | 38.0 mg/ml (38,000 ppm) | N/A (Standard would be based on predicate/ASTM D6978) | > 240 Minutes |
| Ifosfamide | 50.0 mg/ml (50,000 ppm) | N/A (Standard would be based on predicate/ASTM D6978) | > 240 Minutes |
| Irinotecan | 20.0 mg/ml (20,000 ppm) | N/A (Standard would be based on predicate/ASTM D6978) | > 240 Minutes |
| Methotrexate | 25.0 mg/ml (25,000 ppm) | N/A (Standard would be based on predicate/ASTM D6978) | > 240 Minutes |
| Miromycin C | 0.5 mg/ml (500 ppm) | N/A (Standard would be based on predicate/ASTM D6978) | > 240 Minutes |
| Mitoxantrone | 2.0 mg/ml (2,000 ppm) | N/A (Standard would be based on predicate/ASTM D6978) | > 240 Minutes |
| Oxaliplatin | 5.0 mg/ml (5,000 ppm) | N/A (Standard would be based on predicate/ASTM D6978) | > 240 Minutes |
| Paclitaxel | 6.0 mg/ml (6,000 ppm) | N/A (Standard would be based on predicate/ASTM D6978) | > 240 Minutes |
| ThioTepa | 10.0 mg/ml (10,000 ppm) | N/A (Standard would be based on predicate/ASTM D6978) | 98.6 Minutes |
| Vincristine Sulface | 1.0 mg/ml (1,000 ppm) | N/A (Standard would be based on predicate/ASTM D6978) | > 240 Minutes |
Other Non-Clinical Testing Results (from Table 2 and Table 3):
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance / Results |
|---|---|---|---|
| ISO 10993-10:2010 (Irritation) | To determine if device is a skin irritant | The device must be a non-irritant | Pass |
| ISO 10993-10:2010 (Sensitization) | To determine if device is a skin sensitizer | The device must be a non-sensitizer | Pass |
| ISO 10993-5:2009 (Cytotoxicity) | To determine if the device is potential toxicity to L-929 cells | The device must be a non toxicity | Pass |
| ASTM D6124-06 (Residual Powder) | To determine residual powder | ≤ 2 mg/glove | S:0.02, M:0.12, L:0.16, XL:0.14 mg/glove (Pass) |
| ASTM D5151-19 (Freedom from Holes) | To determine water tightness | Meet the requirements of ASTM D5151 AQL 2.5 | S:0/125, M:0/125, L:0/125, XL:0/125 leaks (Pass) |
| ASTM D5250-19 / ASTM D6319-19 (Dimensions - Length) | To determine physical dimensions | S: ≥220 mm; M/L/XL: ≥230 mm | >230 mm (Pass) |
| ASTM D5250-19 / ASTM D6319-19 (Dimensions - Width) | To determine physical dimensions | S: 80±10mm; M: 95±10mm; L: 110±10mm; XL: 120±10mm | S: 88, M: 98-99, L: 110-112, XL: 115-117 mm (Pass) |
| ASTM D5250-19 / ASTM D6319-19 (Dimensions - Thickness) | To determine physical dimensions | Finger: ≥0.05mm; Palm: ≥0.05mm | Finger: 0.101-0.128 mm; Palm: 0.067-0.078 mm (Pass) |
| ASTM D412-06a-2013 (Tensile Strength - Before Aging) | To determine physical properties | Before Aging: Tensile Strength ≥14MPa | 25.4 ~36.3 MPa (Pass) |
| ASTM D412-06a-2013 (Elongation - Before Aging) | To determine physical properties | Before Aging: Ultimate Elongation ≥500% | 508%~563% (Pass) |
| ASTM D412-06a-2013 (Tensile Strength - After Aging) | To determine physical properties | After Aging: Tensile Strength ≥14MPa | 25.8~35.6 MPa (Pass) |
| ASTM D412-06a-2013 (Elongation - After Aging) | To determine physical properties | After Aging: Ultimate Elongation ≥400% | 483%~525% (Pass) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Chemo Permeation: Not explicitly stated as a single number. The testing is done "in accordance with ASTM D6978-05" which specifies test methods. While not clearly itemized in the summary, typical ASTM D6978 testing involves multiple specimens per drug.
- Sample Size for Biocompatibility: Not explicitly stated, but standard ISO 10993 tests involve specific numbers of samples/animals or cell cultures as per the standard.
- Sample Size for Physical Tests (e.g., Holes, Dimensions, Tensile Strength): For "Freedom from Holes," the results show "S:0/125 leaks", "M:0/125 leaks", "L:0/125 leaks", "XL:0/125 leaks," implying a sample size of 125 gloves per size for this test. Other physical tests (dimensions, tensile strength) are usually performed on a representative sample set as per the ASTM standards.
- Data Provenance: Not specified whether the tests were conducted in China (where the manufacturer is located) or another country. The testing methods used are international ASTM and ISO standards. It's a prospective series of tests conducted on the manufactured device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is Not Applicable to this type of device (medical gloves). The "ground truth" for medical gloves is established through objective physical and chemical testing against recognized national and international standards (ASTM, ISO), not through expert clinical consensus or interpretation of medical images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is Not Applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials or studies involving human readers/interpreters to resolve discrepancies, typically for AI/ML diagnostic tools. For physical devices like gloves, performance is measured objectively against predefined criteria.
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
This is Not Applicable. An MRMC study is relevant for AI/ML diagnostic or assistive technologies where human readers are involved in interpretation. This document describes physical, non-AI/ML device performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is Not Applicable. This device is not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is established by:
- Objective physical measurements: e.g., length, width, thickness, tensile strength, elongation, powder content.
- Objective chemical permeation testing: measuring breakthrough time of chemotherapy drugs using analytical methods as specified in ASTM D6978-05.
- Biocompatibility assays: in-vitro (cytotoxicity) and in-vivo (irritation, sensitization) tests as per ISO 10993 standards.
These are validated laboratory test methods, not expert consensus or clinical outcomes data in the usual sense for diagnostic devices.
8. The sample size for the training set
This is Not Applicable. This device is not an AI/ML algorithm that requires a training set. The descriptions pertain to physical performance testing of a manufactured product.
9. How the ground truth for the training set was established
This is Not Applicable. As it's not an AI/ML device, there is no training set or corresponding ground truth establishment process in the context of your request.
§ 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.