(217 days)
The blue colored nitrile examination glove is intended to be worn on the hands of examiner's to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device. The Nitrile Patient Examination Gloves Blue Colored were tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. The tested chemotherapy drug are as follows: Bleomycin Sulfate 15 mg/ml >240 min., Carboplatin 10 mg/ml >240 min., Carmustine (BCNU) 3.3 mg/ml 17.2 min., Cisplatin 1.0 mg/ml >240 min., Cyclophosphamide (Cytoxan) 20.0 mg/ml >240 min., Cytarabine HCI 100 mg/ml >240 min., Dacarbazine (DTIC)10.0 mg/ml >240 min., Daunorubicin 5.0 mg/ml >240 min., Docetaxel 10.0 mg/ml >240 min, Doxorubicin HCI 2.0 mg/ml >240 min., Etoposide (Toposar) 20.0 mg/ml >240 min., Fluorouracil 50.0 mg/ml >240 min., Gemcitabine 38 mg/ml>240 min., Idarubicin 1 mg/ml >240 min., Ifosfamide 50.0 mg/ml >240 min., Irinotecan 20.0 mg/ml >240 min., Mechlorethamine HCI 1.0 mg/ml>240 min., Melphalan 5 mg/ml >240 min., Methotrexate 25 mg/ml >240 min., Mitromycin C. 0.5 mg/ml >240, Mitoxantrone 2.0 mg/ml >240 min., Paclitaxel (Taxol) 6.0 mg/ml >240 min., Thiotepa 10.0 mg/ml 13.9 min., Vincristine Sulfate 1.0 mg/ml >240 min. Warning: Do not use with Carmustine and Thiotepa.
The nitrile examination glove is intended to be worn on the hands of examination between patient and examiner. This is a single-use, powder-free, non-sterile device. The Nitrile Patient Examination Gloves Blue Violet Colored were tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. The tested chemotherapy drug are as follows: Carmustine (BCNU) 3.3 mg/ml 65.3 min., Cisplatin 1.0 mg/ml >240 min., Cyclophosphamide (Cytoxan) 20.0 mg/ml >240 min., Dacarbazine (DTIC)10.0 mg/ml >240 min., Doxorubicin HCI 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 58.3 min. Warning: Do not use with Carmustine and Thiotepa.
The nitrile examination glove is intended to be worn on the hands of examination between patient and examiner. This is a single-use, powder-free, non-sterile device. The Nitrile Patient Examination Gloves Black Colored were tested for use with Fentanyl Citrate per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Fentanyl Citrate 100mcg/2ml >240 minutes.
Power-Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) are non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between a patient and an examiner. The gloves are offered in six sizes, x-small (6.5"), small (7"), medium (8"), large (8.5"), X-large (9"), XXL (9.5"). Three colors are available for all size, includes blue, blue violet and black. The gloves are designed and manufactured in accordance with the ASTM D6319-19 standard and are tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019).
The provided document describes the acceptance criteria and study results for "Nitrile Patient Examination Gloves" (various colors) tested for use with chemotherapy drugs or Fentanyl Citrate. This is a medical device, and the evaluation is based on non-clinical performance standards rather than an AI/ML algorithm.
Therefore, many of the requested fields related to AI/ML studies (sample size for test set, data provenance, number of experts, adjudication method, MRMC comparative effectiveness, standalone performance, ground truth for training set, training set size) are not applicable to this submission.
Here's the breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Item | Methodology / Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Physical Dimensions | |||
| Palm width | ASTM D3767-03(2020) | XS (70±10mm) | |
| S (80±10mm) | |||
| M (95±10mm) | |||
| L (110±10mm) | |||
| XL (120±10mm) | |||
| XXL (≥ 120mm) | Pass | ||
| Length | ASTM D3767-03(2020) | XS (220mm min) | |
| S (220mm min) | |||
| M (230mm min) | |||
| L (230mm min) | |||
| XL (230mm min) | |||
| XXL (230mm min) | Pass | ||
| Thickness | ASTM D3767-03(2020) | Finger: 0.11mm | |
| Palm: 0.05mm | Pass | ||
| Integrity | |||
| Freedom from holes | ASTM D5151-19 | Freedom free hole | |
| AQL 2.5 | Pass | ||
| Physical Properties (before aging) | |||
| Tensile Strength | ASTM D412-16 | ≥ 14Mpa | Pass |
| Ultimate Elongation | ASTM D412-16 | ≥ 500% | Pass |
| Physical Properties (after aging) | |||
| Tensile Strength | ASTM D573-04(2019) | ≥ 14Mpa | Pass |
| Ultimate Elongation | ASTM D573-04(2019) | ≥ 400% | Pass |
| Chemical Content | |||
| Residual Powder Content | ASTM D6124-06(2017) | ≤2mg per glove | Pass |
| Biocompatibility | |||
| Cytotoxicity | ISO 10993-5 | Non-cytotoxic | Under conditions of the study, device extract is cytotoxic. |
| Acute Systemic Toxicity | ISO 10993-11 | Non-acute systemic toxicity | Under conditions of the study, did not show acute systemic toxicity in vivo / Pass |
| Irritation | ISO 10993-10 | Non-irritating | Under the conditions of the study, not an irritant/ Pass |
| Sensitization | ISO 10993-10 | Non-sensitizing | Under conditions of the study, not a sensitizer./ Pass |
| Chemotherapy Drug Permeation | ASTM D6978-05 (Reapproved 2019) | Min. permeation breakthrough time as specified for each drug | Achieved or exceeded specified times for individual drugs (see detailed lists in pages 2, 4, 5, 7, 8, 11, 12). |
| Fentanyl Citrate Permeation | ASTM D6978-05 (Reapproved 2019) | Min. permeation breakthrough time as specified (e.g., >240 min) | Achieved >240 minutes for Fentanyl Citrate (see detailed lists in pages 5, 8, 12). |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated for each test, but standard ASTM and ISO methods generally specify sample sizes. For example, AQL 2.5 for "freedom from holes" implies a sampling plan. Since these are performance tests on manufactured goods, the "test set" would be a batch or set of gloves sampled from production.
- Data Provenance: The document does not specify a country of origin for the testing data. The studies are described as "Non clinical tests" performed according to established international standards (ASTM, ISO). They are prospective in the sense that they are performed on the device to be marketed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable as the "ground truth" for these tests is defined by objective physical and chemical measurements according to standardized protocols (ASTM, ISO), not expert interpretation.
4. Adjudication method for the test set
- Not applicable, as the evaluation is based on objective measurements against defined 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
- Not applicable. This is a submission for physical medical gloves, not an AI/ML-driven device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a submission for physical medical gloves, not an AI/ML-driven device.
7. The type of ground truth used
- The "ground truth" for these tests is the direct measurement of physical properties (e.g., dimensions, tensile strength, elongation), chemical properties (e.g., residual powder content), and barrier properties (permeation breakthrough time for chemotherapy drugs and Fentanyl Citrate) against established, objective industry standards (ASTM, ISO). For biocompatibility, it's the observed biological response to the glove material under controlled test conditions.
8. The sample size for the training set
- Not applicable. This is a submission for physical medical gloves, not an AI/ML-driven device.
9. How the ground truth for the training set was established
- Not applicable. This is a submission for physical medical gloves, not an AI/ML-driven 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.