(100 days)
Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs 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. In addition these gloves were tested for use with Chemotherapy drugs in accordance with ASTM D6978 standards.
The subject device is Nitrile Examination Gloves Sterile with Chemotherapy drugs claims. The subject device is a patient examination glove made from nitrile latex compound, blue color, powder free and sterile (Per 21 CFR 880.6250, class I). The device is direct contact and not to be worn for more than 24 hours. The device meets all the specifications in ASTM D6319-19, Standard specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for biocompatibility per 10993-10, 10993-11 and permeability to chemotherapy drugs per ASTM D6978-05(2019).
The provided document is a 510(k) Premarket Notification from the FDA regarding Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs.
This document does not describe the acceptance criteria and study proving a software algorithm device meets these criteria, but rather the acceptance criteria and test results for a physical medical device (examination gloves).
Therefore, many of the requested categories in your prompt (such as sample size for test/training sets, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, etc.) are not applicable to this type of device and the information provided in the 510(k) summary.
However, I can extract the relevant information about the acceptance criteria and the device's performance based on the provided document.
Device: Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs
Type of Device: Physical Medical Device (Examination Gloves), Class I, reserved
Study Purpose: To demonstrate substantial equivalence to a predicate device (Riverstone Resources SDN BHD. Nitrile Examination Glove, Sterile Tested for use with Chemotherapy Drugs Claim, White (K190725)) by verifying that the subject device meets specific performance standards and has similar technological characteristics.
1. Table of Acceptance Criteria and Reported Device Performance
The document presents several tables detailing the acceptance criteria (standards/specifications) and the results indicating that the device meets these criteria.
| Item/Test | Acceptance Criteria (Standard/Specification) | Reported Device Performance (Results) |
|---|---|---|
| Dimensions | ||
| Length | Minimum 230mm | All size ≥290mm |
| Palm Width (XS) | 70 ± 10mm | 76-78mm |
| Palm Width (S) | 80 ± 10mm | 86-88mm |
| Palm Width (M) | 95 ± 10mm | 96-98mm |
| Palm Width (L) | 110 ± 10mm | 106-108mm |
| Palm Width (XL) | 120 ± 10mm | 116-118mm |
| Palm Width (XXL) | 130 ± 10mm | 126-128mm |
| Physical Properties (Thickness) | ||
| Thickness (Palm) | 0.05mm (min) | 0.09-0.11mm |
| Thickness (Finger) | 0.05mm (min) | 0.13-0.14mm |
| Physical Properties (Tensile Strength) | ||
| Tensile Strength, Before Aging | 14MPa, min | 15.8-20.8 MPa |
| Tensile Strength, After Accelerated Aging | 14MPa, min | 15.6-19.8 MPa |
| Physical Properties (Ultimate Elongation) | ||
| Ultimate Elongation, Before Aging | 500%, min | 500-560% |
| Ultimate Elongation, After Accelerated Aging | 400%, min | 400-500% |
| Integrity | ||
| Freedom from holes | G-I, AQL 2.5 (per ASTM D5151-19, ASTM D6319-19) | Meet and above AQL 2.5 requirements |
| Powder Content | ≤ 2 mg per glove (per ASTM D6124-06(2017), ASTM D6319-19) | ≤ 2 mg, meet requirements |
| Biocompatibility | ||
| Primary Skin Irritation Test | Not an irritant (per ISO 10993-10:2010) | Not an irritant |
| Dermal Sensitization Assay | Not a sensitizer (per ISO 10993-10:2010) | Not a sensitizer |
| Acute Systemic Toxicity Test | No evidence of systemic toxicity (per ISO 10993-11:2017) | No evidence of systemic toxicity |
| Chemotherapy Drug Permeation (Minimum Breakthrough Time - BDT) | ||
| Carmustine (BCNU) (3.3mg/ml) | - (Predicate: 39 min) | 54.3 minutes |
| Cyclophosphamide (20mg/ml) | - (Predicate: >240 min) | >240 minutes |
| Doxorubicin Hydrochloride (2 mg/ml) | - (Predicate: >240 min) | >240 minutes |
| Etoposide (20mg/ml) | - (Predicate: >240 min) | >240 minutes |
| Fluorouracil (50mg/ml) | - (Predicate: >240 min) | >240 minutes |
| Paclitaxel (6mg/ml) | - (Predicate: >240 min) | >240 minutes |
| Thiotepa (10mg/ml) | - (Predicate: 97.6 min) | 196.7 minutes |
| Methotrexate (25mg/ml) | - (Predicate: >240 min) | >240 minutes |
| Cisplatin (1mg/ml) | - (Predicate: N/A) | >240 minutes |
| Vincristine Sulfate (1.0 mg/ml) | - (Predicate: N/A) | >240 minutes |
| Cytarabine HCL (100mg/ml) | - (Predicate: N/A) | >240 minutes |
| Mitoxantrone (2.0 mg/ml) | - (Predicate: N/A) | >240 minutes |
| Mitomycin C (0.5 mg/ml) | - (Predicate: N/A) | >240 minutes |
| Ifosfamide (50.0 mg/ml) | - (Predicate: N/A) | >240 minutes |
| Dacarbazine (DTIC) (10.0 mg/ml) | - (Predicate: N/A) | >240 minutes |
(Note: For chemotherapy drug permeation, the "Acceptance Criteria" are implied by comparison to the predicate device and showing equivalent or better performance. The exact criteria are not explicitly stated for each drug beyond the measured BDT.)
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated as a number of "cases" or "samples" in the way a software algorithm test set would be. The testing is based on batches of gloves or representative samples according to the referenced ASTM/ISO standards. For example, "Freedom from holes" testing follows an AQL (Acceptance Quality Limit) which implies a sampling plan.
- Data Provenance: The tests are non-clinical and conducted based on international standards (ASTM, ISO). The manufacturer is Grand Work Plastic Products Co., Ltd, located in Donggao Industrial Zone, Zanhuang, Hebei, China. The testing would have been performed there or at certified labs used by the manufacturer. The data is retrospective in the sense that it was collected as part of the device's development and qualification prior to the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The "ground truth" for this physical device's performance (e.g., tensile strength, breakthrough time) is established by adherence to standardized physical and chemical testing methods (ASTM, ISO standards), not by human expert consensus or clinical judgment in the traditional sense of diagnostic AI. These standards define the test procedures and acceptance limits.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study requiring human reader adjudication. Performance is measured by laboratory equipment and standard protocols.
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 not an AI-based diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI-based diagnostic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" is established through standardized physical, chemical, and biological testing methods as defined by:
- ASTM D6319-19 (Standard Specification for Nitrile Examination Gloves)
- ASTM D5151-19 (Standard Test Method for Detection of Holes in Medical Gloves)
- ASTM D6124-06(2017) (Standard Test Method for Residual Powder on Medical Gloves)
- ASTM D6978-05(2019) (Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs)
- ISO 10993-10:2010 (Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization)
- ISO 10993-11:2017 (Biological evaluation of medical devices - Part 11: Tests for systemic toxicity)
8. The sample size for the training set
Not applicable. This is not a machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not a machine learning 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.