(131 days)
JR Medic Blue Latex Examination Powder Free Gloves Tested for use with Chemotherapy drugs are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. Additionally, the gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical Glove to Permeation by Chemotherapy Drugs.
The tested chemotherapy drugs and their breakthrough detection times are as follows:
| Tested Chemotherapy Drug Name & Concentration | Minimum Breakthrough Detection Time |
|---|---|
| Carmustine (BCNU) (3.3 mg/ml) | 23.8 Minutes |
| Carboplatin (10 mg/ml) | >240 Minutes |
| Cisplatin (1 mg/ml) | >240 Minutes |
| Cyclophosphamide (Cytoxan) (20 mg/ml) | >240 Minutes |
| Dacarbazine (10.0 mg/ml) | >240 Minutes |
| Doxorubicin HCl (2 mg/ml) | >240 Minutes |
| Etoposide (20 mg/ml) | >240 Minutes |
| Fluorouracil (50 mg/ml) | >240 Minutes |
| Ifosfamide (50 mg/ml) | >240 Minutes |
| Methotrexate (25 mg/ml) | >240 Minutes |
| Mitomycin C (0.5 mg/ml) | >240 Minutes |
| Mitoxantrone (2 mg/ml) | >240 Minutes |
| Paclitaxel (6 mg/ml) | >240 Minutes |
| Thiotepa (10 mg/ml) | 24.1 Minutes |
| Vincristine Sulfate (1 mg/ml) | >240 Minutes |
Please note that the following drugs have low permeation times: Carmustine (BCNU) (3.3 mg/ml) 23.8 Minutes Thiotepa (10 mg/ml) 24.1 Minutes
Warning: Do not use with Carmustine or Thiotepa.
The subject device in 510(K) notification K221157 is JR Medic Blue Latex Examination Powder Free Gloves tested for use with Chemotherapy drugs. The subject device is a patient examination glove made from Natural Rubber Latex, blue color, powder free and non-sterile (as per 21CFR 880.6250, class I).
The subject device meets all the current specifications listed under the ASTM Specification D3578-2019, Standard Specification for Rubber Examination Gloves for Medical Application. This device also complies with requirements for standard practice for assessment of medical gloves to permeation by chemotherapy drugs as per ASTM D6978- 05(2019).
The provided document describes the safety and performance testing of "JR Medic Blue Latex Examination Powder Free Gloves Tested for use with Chemotherapy drugs" to demonstrate substantial equivalence to a predicate device, rather than a study proving the device meets general acceptance criteria for a new medical device technology like an AI algorithm.
Therefore, the requested information elements related to AI/algorithm performance, such as sample size for test set with provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and how ground truth was established for the training set are not applicable to this document.
The document focuses on the physical, chemical, and biological properties of examining gloves and their resistance to chemotherapy drugs.
However, I can extract the acceptance criteria and reported device performance from the provided "G. SUMMARY OF NON-CLINICAL PERFORMANCE DATA" section, focusing on the glove's performance criteria.
1. Table of Acceptance Criteria and the Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D3578-2019 Standard Specification for Rubber Examination Gloves | To determine the length of the gloves | Min 230 mm for all sizes | Small: 304 mm, Medium: 304 mm, Large: 305 mm, X-Large: 305 mm |
| ASTM D3578-2019 Standard Specification for Rubber Examination Gloves | To determine the width of the gloves | Small: 80+/-10mm, Medium: 95+/-10 mm, Large: 111+/-10 mm, X-Large: 115+/-10 mm | Small: 84 mm, Medium: 94 mm, Large: 105 mm, X-Large: 114 mm |
| ASTM D3578-2019 Standard Specification for Rubber Examination Gloves | To determine the thickness of the gloves | Palm: 0.08 mm min, Finger: 0.08 mm min for all sizes | Palm: 0.31mm (all sizes), Finger: 0.38mm (all sizes) |
| ASTM D3578-2019 Standard Specification for Rubber Examination Gloves | To Determine the physical properties - Tensile strength (Before Ageing) | 18Mpa Min for all sizes | Small: 33.16 Mpa, Medium: 32.93 Mpa, Large: 32.43 Mpa, X-Large: 32.36 Mpa |
| ASTM D3578-2019 Standard Specification for Rubber Examination Gloves | To Determine the physical properties - Tensile strength (After Ageing) | 14Mpa Min for all sizes | Small: 30.78 Mpa, Medium: 30.73 Mpa, Large: 30.23 Mpa, X-Large: 30.16 Mpa |
| ASTM D3578-2019 Standard Specification for Rubber Examination Gloves | To Determine the physical properties - Ultimate Elongation (Before Ageing) | 650% Min for all sizes | Small: 1320%, Medium: 1288%, Large: 1376%, X-Large: 1200% |
| ASTM D3578-2019 Standard Specification for Rubber Examination Gloves | To Determine the physical properties - Ultimate Elongation (After Ageing) | 500% Min for all sizes | Small: 1066%, Medium: 1105%, Large: 1225%, X-Large: 1041% |
| ASTM D3578-2019 Standard Specification for Rubber Examination Gloves | To Determine the physical properties - Stress at 500% Elongation (Before Ageing) | 5.5 Mpa Max for all sizes | Small: 5.1 Mpa, Medium: 5.2 Mpa, Large: 5.2 Mpa, X-Large: 5.2 Mpa |
| ASTM D5151-2019 Standard Test Method for Detection of Holes in Medical Gloves | To determine the holes in the gloves | AQL 2.5 | Gloves Passes AQL 1.5 |
| ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder | To determine the residual powder in the gloves | 2 Mg/Glove Max | Small: 0.21 mg/glove, Medium: 0.22 mg/glove, Large: 0.22 mg/glove, X-Large: 0.22 mg/glove |
| ASTM D 5712-95 (Reapproved 2010) Standard Test Method for the Analysis of Protein | To determine the extractable protein in the gloves. | 200 µg/ dm² Max for all sizes | Small: 43.12 µg/ dm², Medium: 41.16 µg/ dm², Large: 42.06 µg/ dm², X-Large: 46.24 µg/ dm² |
| ISO 10993-10 Biological Evaluation of Medical Devices: Irritation Test | To determine the potential of the material under test to produce dermal irritation. | Under the condition of study not an irritant | Under the condition of study not an irritant |
| ISO 10993-10 Biological Evaluation of Medical Devices: Skin Sensitization Test | To determine the skin sensitization potential of the material. | Under the conditions of the study not a sensitizer | Under the conditions of the study not a sensitizer |
| ISO 10993-5:2009 Biological Evaluation of Medical Devices: Cytotoxicity Test | To evaluate the in vitro cytotoxic potential of the test item. | Under the conditions of study non cytotoxic | Under the conditions of the study cytotoxic. |
| Acute systemic toxicity | To determine the acute systemic toxicity potential of the test item. | No specific acceptance criteria stated in table, but implication is to show no systemic toxicity | Under the conditions of the study, no systemic toxicity |
| Material Mediated Pyrogenicity ISO 10993-11:2017(E) / USP 41 | To determine the pyrogenic potential of the test item extract. | Under the conditions of the study non pyrogenic | Under the conditions of the study non pyrogenic |
| ASTM D6978-05 (2019) Standard Practice for Assessment of Medical Glove to Permeation by Chemotherapy Drugs | To assess breakthrough time for various chemotherapy drugs. | Varies per drug, generally aiming for longer breakthrough times. Specific minimums were not explicitly stated as "acceptance criteria" but rather as "minimum breakthrough detection time" in the Indications for Use. | Carmustine (BCNU) (3.3 mg/ml): 23.8 Minutes |
| Carboplatin (10 mg/ml): >240 Minutes | |||
| Cisplatin (1 mg/ml): >240 Minutes | |||
| Cyclophosphamide (Cytoxan) (20 mg/ml): >240 Minutes | |||
| Dacarbazine (10.0 mg/ml): >240 Minutes | |||
| Doxorubicin HCl (2 mg/ml): >240 Minutes | |||
| Etoposide (20 mg/ml): >240 Minutes | |||
| Fluorouracil (50 mg/ml): >240 Minutes | |||
| Ifosfamide (50 mg/ml): >240 Minutes | |||
| Methotrexate (25 mg/ml): >240 Minutes | |||
| Mitomycin C (0.5 mg/ml): >240 Minutes | |||
| Mitoxantrone (2 mg/ml): >240 Minutes | |||
| Paclitaxel (6 mg/ml): >240 Minutes | |||
| Thiotepa (10 mg/ml): 24.1 Minutes | |||
| Vincristine Sulfate (1 mg/ml): >240 Minutes |
Non-Applicable Information for this Document:
The following requested information is not applicable to the provided document as it describes the FDA 510(k) clearance for examination gloves and their resistance to chemotherapy drugs, which is a physical device, not an AI/algorithm-based diagnostic or therapeutic tool.
- Sample size used for the test set and the data provenance: Not applicable - tests are on gloves, not a data set for an algorithm.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable - "ground truth" concept does not apply in this context; instead, it's about objective physical/chemical measurements and biological responses.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
§ 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.