(295 days)
A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The glove was tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Tested chemotherapy drugs are as follows:
| Test Chemotherapy drug & Concentration | Average Breakthrough Detection Time (Minutes) |
|---|---|
| Carmustine (BCNU)(3.3 mg/ml) | 12.1 min. |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | >240 min. |
| Doxorubicin Hydrichloride (2.0mg/) | >240 min. |
| Etoposide (Toposar) (20.0mg/ml) | >240 min. |
| Fluorouracil (50.0mg/ml) | >240 min. |
| Methotrexate (25.0 mg/ml) | >240 min. |
| Paclitaxel (Taxol) (6.0 mg/ml) | >240 min. |
| Thiotepa(10.0 mg/ml) | 10.1 min. |
| Vincristine Sulfate(1.0 mg/ml) | >240 min. |
| Cisplatin(1.0 mg/ml) | >240 min. |
| Dacarbazine(10 mg/ml) | >240 min. |
| Mitomycin C(0.5 mg/ml) | >240 min. |
Please note that the following drugs have extremely low permeation times: Carmustine (BCNU): 12.1 minutes and Thiotepa:10.1 minutes.
Warning: Do not use with Carmustine or Thiotepa
| Fentanyl Citrate & Concentration | Minimum Breakthrough Detection Times |
|---|---|
| Fentanyl Citrate Injection(100 mcg/2ml) | >240 min. |
The Nitrile Patient Examination Gloves with Hyaluronic Acid Blue Colored and Tested for Use with Chemotherapy Drugs and Fentanyl citrate. Aka Synguard C+ Nitrile Exam Gloves are non-sterile, single use only, disposable, powder free examination gloves. The glove is made of nitrile butadiene rubber. Chlorination is applied to the inner surface of the glove to make donning easy. Characteristic:
- Ambidextrous with beaded cuff and straight fingers
- Finger-textured,
- Blue colored
- Containing Hyaluronic Acid coating.
- Six (6) sizes extra-small, small, medium, large, extra-large and XXL.
- Tested against chemotherapy drugs and fentanyl citrate.
The gloves are designed to meets the specifications of ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.
The provided document is a 510(k) summary for a medical device (nitrile patient examination gloves with hyaluronic acid) and details the performance testing against established standards.
Here's a breakdown of the acceptance criteria and study information, based on the provided text:
1. A table of acceptance criteria and the reported device performance:
The document includes a "Technological Characteristics Comparison Table" (pages 7-9) that serves this purpose. It compares the applicant's device to a predicate device (K200671). The "Acceptance Criteria" column effectively outlines the criteria, and the "Anhui Intco Medical Products Co., Ltd. Nitrile Patient Examination Gloves..." column shows the reported device performance.
| Characteristics | Acceptance Criteria (from predicate/standards) | Reported Device Performance (Anhui Intco Medical Products Co., Ltd.) | Comparison Conclusions |
|---|---|---|---|
| Product Code | LZA, LZC, OPJ, QDO | LZA, LZC, OPJ, QDO | (Implicitly "Same") |
| Intended use | A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The glove was tested for use with Chemotherapy Drugs as per ASTM D6978-05. | A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The glove was tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. | Same |
| Material used | Nitrile | Nitrile | Identical |
| Color | Blue | Blue | Same |
| Single use | Single Use | Yes | Same |
| Non Sterile | Non Sterile | Non Sterile | Same |
| Other | (Implicit: Additives related to coating) | Hyaluronic Acid coated on the donning surface | Different(1) |
| Dimensions | Overall Length (mm): For XS, S, Min 220mm; For M,L,XL,XXL Min 230mm. Width (± 10mm): XS=70mm, S=80mm, M=95mm, L=110mm, XL=120mm, XXL=130mm. Thickness at Palm (mm) Min: 0.05mm. Thickness at Finger Tip (mm) Min: 0.05mm. | Complies with ASTM D6319-19: X Small 70±10, Small 80 ±10, Medium 95±10, Large 110 ±10, X large 120 ±10, XX Large 130 ±10. Thickness: Palm - 0.05mm min., Finger - 0.05 mm min. | Similar |
| Physical properties | Before Ageing: Tensile Strength (MPa) = 14min, Ultimate Elongation (%) = 500min. After Aging: Tensile Strength (MPa) = 14min, Ultimate Elongation (%) = 400min. | Meets ASTM D6319-19: Tensile Strength: Before Aging 14 MPa, min. After Aging 14 MPa, min. Elongation: Before Aging 500% min. After Aging 400% min. | Meets the criteria |
| Freedom from pinholes | AQL 2.5, Inspection Level G-1 | In accordance with ASTM D6319-19 and ASTM D5151-19, G-1, AQL 2.5 | Meets the criteria |
| Residual Powder | Less than 2mg per glove ASTM D 6124-06 | Average powder residue 240 min. |
- Doxorubicin Hydrochloride (2.0mg/), Breakthrough time: >240 min.
- Etoposide (Toposar) (20.0mg/ml), Breakthrough time: >240 min.
- Fluorouracil (50.0mg/ml), Breakthrough time:>240 min.
- Methotrexate (25.0 mg/ml), Breakthrough time: >240 min.
- Paclitaxel (Taxol) (6.0 mg/ml), Breakthrough time: >240 min.
- Thiotepa, Breakthrough time: 10.1 min.
- Vincristine Sulfate (1.0 mg/ml), Breakthrough time:>240 min.
- Cisplatin (1.0 mg/ml), Breakthrough time:>240 min.
- Dacarbazine (10 mg/ml), Breakthrough time:>240 min.
- Mitomycin C (0.5 mg/ml), Breakthrough time:>240 min.
- Fentanyl Citrate Injection (100 mcg/2ml), Breakthrough time:>240 min. | Similar |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample sizes for the test sets in the non-clinical tests (e.g., how many gloves were tested for pinholes, how many animals were used for biocompatibility testing). However, it refers to industry standards like ASTM and ISO, which typically define appropriate sample sizes for such tests.
- Provenance: The tests were performed in accordance with international standards (ASTM, ISO). The manufacturing company is Anhui Intco Medical Products Co., Ltd. located in Anhui, China. The testing itself is presented as non-clinical testing to demonstrate performance against these standards. The testing format suggests a retrospective evaluation against pre-defined performance criteria.
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 information is not applicable as the document describes performance testing of physical characteristics of gloves against codified standards (ASTM, ISO), not an AI device or a diagnostic device requiring expert interpretation of results to establish ground truth. The "ground truth" here is the pass/fail criteria defined by the standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This is not applicable as the document describes performance testing of physical characteristics against codified standards. There is no subjective adjudication process for the test results.
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. The device is a medical glove, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This is not applicable. The device is a medical glove, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for the performance tests conducted (e.g., tensile strength, pinholes, chemical permeation, biocompatibility) is established by industry standards and test methods (ASTM D6319-19, ASTM D5151-19, ASTM D6124-06, ASTM D6978-05, ISO 10993 series). These standards define the acceptable range or threshold for a given characteristic to be considered compliant.
8. The sample size for the training set:
This is not applicable. The 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:
This is not applicable.
§ 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.