(233 days)
Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Low Dermatitis and Fentanyl Permeation Resistance Claim is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Low Dermatitis Potential - this product demonstrated reduced potential for sensitizing users to chemical additives.
Tested for Use with Chemotherapy Drugs - Gloves have been tested for use with chemotherapy drugs using ASTM D6978-05 and will be labeled with a statement of compliance and a summary of the testing results.
Fentanyl Permeation Resistance Claim - Under the testing conditions of ASTM D6978-05, Fentanyl Citrate Injection (100mcg/2mL) was found to have no breakthrough detected up to 240 minutes.
Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Low Dermatitis and Fentanyl Permeation Resistance Claim
This document is an FDA 510(k) clearance letter for "Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Low Dermatitis and Fentanyl Permeation Resistance Claim." It primarily focuses on the substantial equivalence determination for this medical device and its performance against specific chemical permeation tests.
Given the nature of the document, which pertains to a physical medical device (gloves) and not an AI/ML-driven device or diagnostic tool, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/ML or diagnostic performance (e.g., sample size for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance) is not applicable.
The "acceptance criteria" and "study" described in the document relate to the gloves' physical and chemical barrier properties, specifically:
- Low Dermatitis Potential: Demonstrated reduced potential for sensitizing users to chemical additives. (The document doesn't detail the specific study methodology for this, but it implies a test was conducted.)
- Chemotherapy Drug Permeation Resistance: Tested for permeation using ASTM D6978-05.
- Fentanyl Permeation Resistance: Tested for permeation using ASTM D6978-05.
Here's how the provided information fits the closest possible interpretation of your request for this type of device:
Acceptance Criteria and Device Performance (for physical/chemical properties):
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Barrier to Chemotherapy Drugs | |
| (Demonstrate sufficient permeation resistance for a range of commonly used chemotherapy drugs when tested according to ASTM D6978-05) | Minimum Breakthrough Detection Time (minutes): |
- Bleomycin Sulfate: >240
- Busulfan: >240
- Carboplatin: >240
- Carmustine: 12.4
- Cisplatin: >240
- Chloroquine: >240
- Cyclophosphamide: >240
- Cyclosporin: >240
- Cytarabine HCl: >240
- Dacarbazine: >240
- Daunorubicin HCl: >240
- Docetaxel: >240
- Doxorubicin Hydrochloride: >240
- Epirubicin (Ellence): >240
- Etoposide: >240
- Fludarabine: >240
- Fluorouracil: >240
- Gemcitabine: >240
- Idarubicin: >240
- Ifosfamide: >240
- Irinotecan: >240
- Mechlorethamine HCl: >240
- Melphalan: >240
- Methotrexate: >240
- Mitomycin: >240
- Mitoxantrone: >240
- Oxaliplatin: >240
- Paclitaxel: >240
- Paraplatin: >240
- Retrovir: >240
- Rituximab: >240
- Thiotepa: 24.4
- Topotecane: >240
- Trisonex: >240
- Velcade: >240
- Vincristine Sulfate: >240
Note: Carmustine and Thiotepa showed significantly lower permeation times, which the labeling explicitly highlights. |
| Barrier to Fentanyl Citrate Injection
(Demonstrate resistance to fentanyl permeation when tested according to ASTM D6978-05) | Fentanyl Citrate Injection (100mcg/2mL): No breakthrough detected up to 240 minutes. |
| Low Dermatitis Potential
(Demonstrate reduced potential for sensitizing users to chemical additives) | Demonstrated reduced potential for sensitizing users to chemical additives. |
Regarding the specific questions tailored for AI/ML or diagnostic performance studies:
- Sample size used for the test set and data provenance: Not applicable. The "test set" here refers to chemical permeation tests on glove samples, not patient data for an AI algorithm. The provenance would be the gloves themselves and the chemicals used in the ASTM D6978-05 standard.
- Number of experts used to establish the ground truth for the test set and qualifications: Not applicable. "Ground truth" for this device is established by chemical analysis according to a standardized protocol (ASTM D6978-05), not by human expert opinion on images or clinical cases.
- Adjudication method: Not applicable. Chemical tests follow a protocol, not an adjudication process.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This type of study is for evaluating human performance, often with AI assistance, in diagnostic tasks.
- If a standalone (i.e., algorithm-only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm.
- The type of ground truth used: For chemical resistance, the ground truth is the quantitative measurement of breakthrough time according to a standardized chemical test (ASTM D6978-05). For low dermatitis, it would be results from a dermatological irritation/sensitization test.
- The sample size for the training set: Not applicable. There is no AI model being trained.
- How the ground truth for the training set was established: Not applicable.
In summary, this FDA document is for a conventional Class I medical device (nitrile examination gloves) and its clearance is based on laboratory testing of its physical and chemical properties, not on AI/ML performance or diagnostic accuracy studies.
§ 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.