(72 days)
The Powder free, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl, 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: Carmustine ( 3.3mg/mL 3,300 ppm) 11.1 min Cisplatin ( 1.0 mg/mL 1,000 ppm) >240 min Cyclophosphamide (20 mg/mL 20,000 ppm) >240 min Cytarabine (Cytosine) (100 mg/mL 100,000 ppm) >240 min Dacarbazine (10 mg/mL 10,000 ppm) >240 min Doxorubicin (Adriamycin) (2.0 mg/mL 2,000 ppm) >240 min Etoposide (Toposar) (20.0 mg/mL 20,000 ppm) >240 min Fluorouracil (5 Flu) (50.0 mg/mL 50,000 ppm) >240 min Ifosfamide (50.0 mg/mL 50,000 ppm) >240 min Methotrexate (25.0 mg/mL 25,000 ppm) >240 min Mitomycin C (0.5 mg/mL 500 ppm) >240 min Mitoxantrone HCL (2.0 mg/mL 2,000 ppm >240 min Paclitaxel (6.0 mg/mL 6,000 ppm) >240 min Thiotepa (10.0 mg/mL 10.000 ppm) 34.8 min Vincristine Sulfate (1.0 mg/mL 1,000 ppm >240 min Fentanyl Citrate Injection (100 mcg/2mL) >240 min Note: Carmustine and Thiotepa have extremely low permeation times of 11.1 and 34.8 minutes respectively. Warning: Do Not Use with Carmustine. Thiotepa
The Powder free, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl are non-sterile, single use only, disposable examination gloves intended for medical purposes to be worn by examiners to prevent contamination between the patient and the examiner. The gloves are blue color, powder free, nitrile ambidextrous gloves are offered in five sizes, extra small, small, medium, large, and extra-large, packed in a paper box. The gloves are designed and manufactured in accordance with the ASTM D6319 standard and are tested for use with chemotherapy drugs and Fentanyl per ASTM D6978 standard.
The provided document describes the acceptance criteria and results for the "Powder free, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl" device.
Here's an analysis of the requested information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance (Proposed Device) |
|---|---|
| Dimensions | Pass |
| Length (XS, S) | 220mm min |
| Length (M, L, XL) | 230mm min |
| Width (XS) | 70±10mm |
| Width (S) | 80±10mm |
| Width (M) | 95±10mm |
| Width (L) | 110±10mm |
| Width (XL) | 120±10mm |
| Thickness (Finger) | ≥0.05mm |
| Thickness (Palm) | ≥0.05mm |
| Physical properties (ASTM D6319-19) | Pass |
| Tensile Strength (Before Aging) | ≥14 MPa, min. |
| Tensile Strength (After Aging) | ≥14 MPa, min. |
| Elongation (Before Aging) | 500%, min. |
| Elongation (After Aging) | 400%, min. |
| Freedom from holes (ASTM D5151-19) | Pass |
| No leakage at sampling level of G-1, AQL 2.5 | Complies |
| Residual Powder (ASTM D6124-06) | Pass |
| 240 min | |
| Cyclophosphamide (20 mg/mL 20,000 ppm) | >240 min |
| Cytarabine (Cytosine) (100 mg/mL 100,000 ppm) | >240 min |
| Dacarbazine (10 mg/mL 10,000 ppm) | >240 min |
| Doxorubicin (Adriamycin) (2.0 mg/mL 2,000 ppm) | >240 min |
| Etoposide (Toposar) (20.0 mg/mL 20,000 ppm) | >240 min |
| Fluorouracil (5 Flu) (50.0 mg/mL 50,000 ppm) | >240 min |
| Ifosfamide (50.0 mg/mL 50,000 ppm) | >240 min |
| Methotrexate (25.0 mg/mL 25,000 ppm) | >240 min |
| Mitomycin C (0.5 mg/mL 500 ppm) | >240 min |
| Mitoxantrone HCL (2.0 mg/mL 2,000 ppm) | >240 min |
| Paclitaxel (6.0 mg/mL 6,000 ppm) | >240 min |
| Thiotepa (10.0 mg/mL 10,000 ppm) | 34.8 min |
| Vincristine Sulfate (1.0 mg/mL 1,000 ppm) | >240 min |
| Fentanyl Citrate Injection (100 mcg/2mL) | >240 min |
| Biocompatibility (ISO 10993-1, -5, -10, -11, -23) | Pass |
| Irritation (ISO 10993-23) | Not an irritant |
| Sensitization (ISO 10993-10) | Not a sensitizer |
| In Vitro Cytotoxicity (ISO 10993-5) | Showed potential toxicity (Note: See point 7 for context) |
| Acute Systemic Toxicity (ISO 10993-11) | Does not induce acute systemic toxicity response |
Note on Biocompatibility: The document states that despite the in vitro cytotoxicity showing "potential toxicity," the overall biocompatibility assessment was deemed acceptable, asserting it "does not raise different safety or performance questions since the subject device has acceptable biocompatibility per the biocompatibility endpoint assessment."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the exact sample sizes used for each performance test (e.g., how many gloves were tested for dimensions, holes, tensile strength, or chemotherapy permeation). It references standards like ASTM D6319-19, ASTM D5151-19 (G-1, AQL 2.5), ASTM D6124-06, and ASTM D6978-05, which would prescribe the methodology and sample sizes.
The data provenance regarding country of origin or retrospective/prospective nature is not explicitly mentioned. The applicant, Anhui Powerguard Technology Co., Ltd., is based in China, suggesting the testing may have been conducted there or through contract labs globally.
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 device is a physical medical device (examination gloves), not an AI/software device that requires expert interpretation of images or data to establish ground truth. Therefore, the concept of "experts used to establish ground truth" in the context of medical imaging or AI algorithms is not applicable here. The "ground truth" for this device is established by physical and chemical testing against established engineering and safety standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Similarly, as this is a physical device and not an AI/software for diagnostic interpretation, adjudication methods like 2+1 or 3+1 are not applicable. Performance is measured against quantitative criteria defined by international standards.
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
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic tools, not for medical gloves.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, this question is not applicable. The device is a physical product (gloves), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance is established by:
- International Standards: ASTM D6319-19 (Standard Specification for Nitrile Examination Gloves for Medical Application), ASTM D6124-06 (Standard Test Method for Residual Powder on Medical Gloves), ASTM D5151-19 (Standard Test Method for Detection of Holes in Medical Gloves), and ASTM D6978-05 (Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs).
- Biocompatibility Standards: ISO 10993-1, ISO 10993-5 (In Vitro Cytotoxicity), ISO 10993-10 (Dermal Sensitization), ISO 10993-11 (Acute Systemic Toxicity), and ISO 10993-23 (Primary Skin Irritation).
These standards define the methodologies and acceptance limits for evaluating the physical, chemical, and biological properties of the gloves.
Regarding In Vitro Cytotoxicity: The report notes that the "test article extract showed potential toxicity." However, the analysis in the 510(K) Summary explicitly states: "Analysis: In vitro cytotoxicity and acute systemic toxicity information for the predicate device is not publicly available. This does not raise different safety or performance questions since the subject device has acceptable biocompatibility per the biocompatibility endpoint assessment." This indicates that while an in vitro test showed some indication, the overall biocompatibility assessment, likely considering other in vivo tests like skin irritation and sensitization which passed, led to the conclusion of acceptable biocompatibility. This implicitly uses the wider expert consensus and risk assessment methodology embedded in the ISO 10993 series of standards as the 'ground truth' for biocompatibility.
8. The sample size for the training set
This question is not applicable as this is a physical medical device, not an AI/software device that requires a training set.
9. How the ground truth for the training set was established
This question is not applicable as this is a physical medical device, not an AI/software device.
§ 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.