(142 days)
A disposable medical glove to be worn on the hand of the healthcare and similar personnel to prevent contamination between healthcare personnel and patient.
Non-sterile , Powder-free Blue Nitrile Examination Gloves , Tested for use with Chemotherapy Drugs.
The provided documents describe the performance of "Non-sterile, Powder-free Blue Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs" (K101822) against various acceptance criteria relevant to medical examination gloves and specifically for their resistance to chemotherapy drugs.
Here’s a breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the device are largely based on established ASTM (American Society for Testing and Materials) standards and a comparison to a legally marketed predicate device (K082957). The key performance indicator for chemotherapy drug resistance is the "Breakthrough Detection Time" as per ASTM D6978-05.
Acceptance Criteria and Reported Device Performance for K101822
| Characteristic and Parameter | Acceptance Criteria | Reported Device Performance | Meets Criteria? |
|---|---|---|---|
| General Glove Characteristics | |||
| Device Class | Class I (as per predicate) | Class I | Yes |
| Product Code | LZA (as per predicate) | LZA | Yes |
| Glove Color | Blue (as per predicate) | Blue | Yes |
| Dimensions | Meets ASTM D6319-00a-05 | Meets ASTM D6319-00a-05 | Yes |
| Physical Properties | Meets ASTM D6319-00a-05 | Meets ASTM D6319-00a-05 | Yes |
| Freedom From Pinholes | Meets ASTM D6319-00a-05 (and/or ISO 2859-1, ASTM D5151-06) | Meets ASTM D6319-00a-05 | Yes |
| Powder-free | Meets ASTM D6124-06 | Meets ASTM D6124-06 | Yes |
| Biocompatibility | |||
| Primary Skin Irritation | Passes Primary Skin Irritation in Rabbits (as per predicate) | Passes Primary Skin Irritation in Rabbits | Yes |
| Sensitization | Passes Guinea Pig Maximization (similar to predicate's Guinea Pig Sensitization) | Passes Guinea Pig Maximization | Yes |
| Chemotherapy Drugs Permeation (ASTM D6978-05) | |||
| Cisplatin | > 240 minutes (as per predicate) | > 240 minutes | Yes |
| Cyclophosphamide (Cytoxan) | > 240 minutes (as per predicate) | > 240 minutes | Yes |
| Doxorubicin Hydrochloride | > 240 minutes (as per predicate) | > 240 minutes | Yes |
| Etoposide (Toposar) | > 240 minutes (as per predicate) | > 240 minutes | Yes |
| Flurouracil | > 240 minutes (as per predicate) | > 240 minutes | Yes |
| Paclitaxel (Taxol) | > 240 minutes (as per predicate) | > 240 minutes | Yes |
| Vincristine Sulfate | > 240 minutes (as per predicate) | > 240 minutes | Yes |
| Dacarbazine (DTIC) | > 240 minutes (as per predicate) | > 240 minutes | Yes |
| Methotrexate | > 240 minutes (as per predicate) | > 240 minutes | Yes |
| Carmustine (BCNU) | Not specified as a pass/fail threshold, but noted as having extremely low permeation time in the predicate | 0.49 minutes | No (Note: Not approved for use with this drug) |
| Thiotepa | Not specified as a pass/fail threshold, but noted as having extremely low permeation time in the predicate | 2.61 minutes | No (Note: Not approved for use with this drug) |
| Labeling | Meets FDA requirement | Meets FDA requirement | Yes |
Summary of Study Proving Acceptance:
The device K101822 was shown to meet its acceptance criteria through various tests described in the "Substantial Equivalence Discussion" (Document 2, page 2 of 2) and the "CONCLUSION" (Document 4, page 1 of 1). The primary study for chemotherapy drug resistance was conducted according to ASTM D6978-05. For other characteristics like dimensions, physical properties, freedom from pinholes, and powder-free status, the device was tested against and found to meet ASTM D6319-00a-05, ISO 2859-1 (for water leak test), ASTM D5151-06 (for detection of holes), and ASTM D6124-06 respectively. Biocompatibility tests included Primary Skin Irritation in Rabbits and Guinea Pig Maximization tests.
The device's performance was directly compared to a legally marketed predicate device, Siam Sempermed Corp. Ltd.'s Non-sterile, Powder-free Nitrile Examination Glove (K082957), showing substantial equivalence in all tested parameters, except for highlighting the short permeation times for Carmustine (BCNU) and Thiotepa, for which the gloves are explicitly not approved.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The specific sample sizes for each test (e.g., number of gloves tested for chemotherapy permeation, number of rabbits/guinea pigs for biocompatibility, or specific counts for physical properties) are not explicitly stated in the provided documents. The documents only state that the device "Meets ASTM D6319-00a-05," "Meets ASTM D6124-06", etc., which implies that the testing was performed according to the methodologies and sample size requirements specified in those respective ASTM/ISO standards.
- Data Provenance: The data is presented as part of a 510(k) Premarket Notification submission to the FDA by SGMP Company Limited, located in Thailand (Document 0, page 1 of 2). This indicates the testing was conducted by or on behalf of the manufacturer, and generally, such data would be generated in a controlled laboratory environment. The documents do not specify the country of origin of the specific lab that conducted these tests, but the manufacturer is based in Thailand. The studies were retrospective in the sense that they were conducted to characterize the finished medical device for regulatory submission, rather than as part of a clinical trial.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to this type of device submission. The "ground truth" for the performance of these examination gloves is established through standardized laboratory tests (e.g., ASTM standards) measuring physical and chemical properties, not through expert human interpretation or clinical ground truth. Therefore, there are no "experts" in the sense of medical professionals establishing ground truth for diagnostic accuracy, nor are their qualifications relevant here.
4. Adjudication method for the test set
This question is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human judgment (e.g., for image interpretation) to resolve disagreements among experts. The performance of these gloves is determined by objective, quantitative laboratory measurements according to published 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
This question is not applicable. An MRMC study is relevant for diagnostic devices (e.g., AI algorithms for image interpretation) where human readers evaluate cases with and without AI assistance. This submission describes an examination glove, which is a physical barrier device, and does not involve human readers or AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable. This describes a physical medical device (examination gloves), not an algorithm or AI system.
7. The type of ground truth used
The ground truth used for performance validation is based on objective, quantitative measurements obtained through standardized laboratory testing protocols, primarily from ASTM standards (D6319-00a-05, D6124-06, D6978-05) and ISO 2859-1. For biocompatibility, the ground truth is established by the observed biological responses in animal models (rabbits and guinea pigs) according to standardized tests for skin irritation and sensitization. The device's performance is then compared against the requirements specified in these standards and against the performance of a legally marketed predicate device.
8. The sample size for the training set
This question is not applicable. This is a physical medical device, not an AI model or algorithm that requires a "training set" of data.
9. How the ground truth for the training set was established
This question is not applicable as there is no training set for this type of 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.