(13 days)
Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs) is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. This is a single-use, powder-free, non-sterile device.
Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs) is a Class I patient examination gloves bearing the product codes LZA, LZC, OPJ (21CFR880.6250). They meet all the current specifications listed under the ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application and also complies with requirements for Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs as per ASTM D6978-05 (2019). They are made from Carboxylated Nitrile. These gloves are blue in color and are powder free. The product is non-sterile, textured, ambidextrous with beaded cuff and single use only. Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs) with sizes X-Small, Small, Medium, Large, X-Large and XX-Large are included in the submission.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) summary for "Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs)":
1. A table of acceptance criteria and the reported device performance
| Characteristic / Test Method | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Physical Dimensions (ASTM D6319-19) | ||
| Length | X-Small: 220 mm min; Small: 220 mm min; Medium: 230 mm min; Large: 230 mm min; X-Large: 230 mm min; XX-Large: 230 mm min | X-Small: 270 mm; Small: 273 mm; Medium: 274 mm; Large: 276 mm; X-Large: 278 mm; XX-Large: 276 mm |
| Width | X-Small: 70+/-10 mm; Small: 80+/-10 mm; Medium: 95+/-10 mm; Large: 110+/-10 mm; X-Large: 120+/-10 mm; XX-Large: 130+/-10 mm | X-Small: 72 mm; Small: 82 mm; Medium: 97 mm; Large: 103 mm; X-Large: 112 mm; XX-Large: 126 mm |
| Thickness | Palm: 0.05 mm min for all sizes; Finger: 0.05 mm min for all sizes | Palm: 0.12 mm for all sizes; Finger: 0.14 mm for all sizes |
| Physical Properties (ASTM D6319-19) | ||
| Tensile Strength (Before Ageing) | 14 MPa min for all sizes | X-Small: 17.7 MPa; Small: 18.1 MPa; Medium: 18.3 MPa; Large: 18.4 MPa; X-Large: 18.2 MPa; XX-Large: 18.5 MPa |
| Tensile Strength (After Ageing) | 14 MPa min for all sizes | X-Small: 16.8 MPa; Small: 17.3 MPa; Medium: 17.2 MPa; Large: 17.6 MPa; X-Large: 17.5 MPa; XX-Large: 17.6 MPa |
| Ultimate Elongation (Before Ageing) | 500% min for all sizes | X-Small: 637%; Small: 634%; Medium: 647%; Large: 630%; X-Large: 644%; XX-Large: 644% |
| Ultimate Elongation (After Ageing) | 400% min for all sizes | X-Small: 532%; Small: 539%; Medium: 542%; Large: 536%; X-Large: 529%; XX-Large: 533% |
| Freedom from Holes (ASTM D5151-19) | AQL 2.5 | Gloves Passes AQL 2.5 |
| Residual Powder (ASTM D6124-06) | $\leq$ 2 mg/glove | X-Small: 0.21 mg/glove; Small: 0.18 mg/glove; Medium: 0.18 mg/glove; Large: 0.19 mg/glove; X-Large: 0.21 mg/glove; XX-Large: 0.20 mg/glove |
| Chemotherapy Drug Permeation (ASTM D6978-05 (2019)) | ||
| Carboplatin (10mg/ml) | > 240 Minutes | > 240 Minutes |
| Carmustine (3.3mg/ml) | Not specified as an acceptance criterion value, but rather a reported breakthrough time leading to a warning. No specific "pass/fail" for this drug against a threshold is listed. | 15.9 Minutes |
| Cisplatin (1mg/ml) | > 240 Minutes | > 240 Minutes |
| Cyclophosphamide (20mg/ml) | > 240 Minutes | > 240 Minutes |
| Cytarabine HCl (100mg/ml) | > 240 Minutes | > 240 Minutes |
| Dacarbazine (10mg/ml) | > 240 Minutes | > 240 Minutes |
| Docetaxel (10mg/ml) | > 240 Minutes | > 240 Minutes |
| Doxorubicin HCl (2mg/ml) | > 240 Minutes | > 240 Minutes |
| Etoposide (20mg/ml) | > 240 Minutes | > 240 Minutes |
| Fluorouracil (50mg/ml) | > 240 Minutes | > 240 Minutes |
| Gemcitabine (38mg/ml) | > 240 Minutes | > 240 Minutes |
| Ifosfamide (50mg/ml) | > 240 Minutes | > 240 Minutes |
| Irinotecan (20mg/ml) | > 240 Minutes | > 240 Minutes |
| Mechlorethamine HCl (1mg/ml) | > 240 Minutes | > 240 Minutes |
| Melphalan (5mg/ml) | > 240 Minutes | > 240 Minutes |
| Methotrexate (25mg/ml) | > 240 Minutes | > 240 Minutes |
| Mitoxantrone (2mg/ml) | > 240 Minutes | > 240 Minutes |
| Paclitaxel (6mg/ml) | > 240 Minutes | > 240 Minutes |
| Thiotepa (10mg/ml) | Not specified as an acceptance criterion value, but rather a reported breakthrough time leading to a warning. No specific "pass/fail" for this drug against a threshold is listed. | 54.2 Minutes |
| Biocompatibility (ISO 10993 Series) | ||
| Primary Skin Irritation (ISO 10993-23) | Under the condition of study not an irritant | Under the condition of study, not an irritant |
| Dermal Sensitization (ISO 10993-10) | Under the conditions of the study, not a sensitizer | Under the conditions of the study, not a sensitizer |
| In Vitro Cytotoxicity (ISO 10993-5) | Under the conditions of the study, non-cytotoxic | Under the conditions of the study, non-cytotoxic |
| Acute Systemic Toxicity (ISO 10993-11) | Under the conditions of study, the device extracts do not pose a systemic toxicity concern | Under the conditions of the study, the test item did not produce any adverse effect |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the specific sample sizes used for each test. For many of the physical and chemical property tests (e.g., dimensions, tensile strength, freedom from holes, residual powder, chemotherapy drug permeation), the relevant ASTM standards (e.g., ASTM D6319-19, ASTM D5151-19, ASTM D6124-06, ASTM D6978-05) would specify the required statistical sampling plans, but the summary document only provides the results.
Similarly, for biocompatibility tests (ISO 10993 series), the number of animals or cell cultures used is not detailed in this summary, but the standards themselves outline the required protocols.
The data provenance is not explicitly stated in terms of country of origin of the data or whether it was retrospective or prospective. Given that these are bench and lab tests for a premarket notification, it's highly probable that the tests were conducted prospectively by the manufacturer or a contracted testing laboratory to demonstrate compliance with the referenced standards.
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 and not provided since the studies performed are bench testing and biocompatibility testing against established international standards (ASTM and ISO). These types of tests do not typically involve human experts establishing a "ground truth" through interpretation, as would be the case for an AI diagnostic device. Instead, the "ground truth" is defined by the objective measurement parameters and criteria specified in the standard test methods themselves.
4. Adjudication method for the test set
Not applicable. As noted above, these are objective bench and lab tests against predefined specifications in standards. There is no subjective interpretation requiring an adjudication method like 2+1 or 3+1. The results are quantitative measurements or direct observations (e.g., passes/fails AQL).
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 diagnostic device. Therefore, no MRMC study involving human readers or AI assistance was conducted or would be relevant.
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 AI algorithm.
7. The type of ground truth used
The "ground truth" for the performance evaluation of these nitrile examination gloves are the acceptance criteria defined by the relevant ASTM and ISO standards. These standards provide:
- Specific measurable thresholds (e.g., minimum length, minimum tensile strength, maximum residual powder).
- Defined test methods and methodologies (e.g., how to measure breakthrough time for chemotherapy drugs, how to assess irritation or sensitization).
- Statistical sampling plans (e.g., AQL for freedom from holes).
Compliance with these pre-defined, objective criteria from the standards constitutes the "ground truth" for the device's performance.
8. The sample size for the training set
Not applicable. This is a physical device (medical glove), not an AI model. Therefore, there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for a physical medical 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.