(292 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or fingers to prevent contamination between patient and examiner.
These gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Glove to Permeation by chemotherapy drugs.
The SHOWA® Blue Nitrile Powder Free Medical Examination Glove is a single use, disposable device made from a Nitrile Butadiene Rubber, blue in color, powder free and non-sterile (per 21 CFR Part 880.6250, class I). The device meets all the specifications in ASTM D6319-10. Standard specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for biocompatibility and permeability to chemotherapy drugs.
The SHOWA® Blue Nitrile Powder Free Medical Examination Glove is designed to be used for medical purposes to be worn on the examiner's hands or fingers to prevent contamination between the patient and the examiner (product code LZA). In addition, these gloves were tested for use with chemotherapy drugs (product code LZC) in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Glove to Permeation by chemotherapy drugs.
The provided document is a 510(k) Premarket Notification for a medical device, specifically the "SHOWA® Blue Nitrile Powder Free Medical Examination Glove." It outlines the acceptance criteria and the studies performed to demonstrate the device's substantial equivalence to a predicate device.
Here's the requested information:
1. A table of acceptance criteria and the reported device performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319-10 (Dimensions) | Demonstrate accurate sizing | Overall Length (mm): 220 mm (sizes XS – S) and 230 mm (sizes M - XL) | |
| Width (± 10 mm): Size XS = 70 mm, Size S = 80 mm, Size M = 95 mm, Size L = 110 mm, Size XL = 120 mm | |||
| Thickness at Palm (mm): 0.05 min. | |||
| Thickness at Finger Tip (mm): 0.05 min. | Pass | ||
| ASTM D6319-10 (Tensile Properties) | Demonstrate tensile conforming properties | Before Aging (D 412): | |
| Tensile Strength (MPa) = 14 min | |||
| Ultimate Elongation (%) = 500 min. | |||
| After Aging (D 573) (70°C ± 2°C for 166 hrs ± 2 hrs.): | |||
| Tensile Strength (MPa) = 14 min | |||
| Ultimate Elongation (%) = 400 min | Pass | ||
| ASTM D6319-10 (Freedom from Holes) | Demonstrate glove integrity | Freedom from Holes (D 5151): AQL 2.5 Inspection Level G-1 | Pass |
| ASTM D6319-10 (Residual Powder) | Demonstrate biocompatibility: Residual powder | Residual Powder (D 6124): ≤ 2.0 mg/pc | Pass |
| Primary Skin Irritation Test ISO 10993-10 | Demonstrate biocompatibility: Skin irritation | Under the conditions of the study, Not a primary skin irritant. | Pass |
| Dermal Sensitization Assay ISO 10993-10 | Demonstrate biocompatibility: Skin sensitivity | Under the conditions of the study, Not a contact sensitizer. | Pass |
| Acute Systemic toxicity Study ISO 10993-11 | Demonstrate biocompatibility: acute systemic toxicity | Under conditions of the ISO Acute Systemic Injection test, not toxic | Pass |
| Open box testing AAMI 11737-1 | Demonstrate acceptable open box bioburden | Acceptable bioburden levels after 30 days open box. | Pass |
| ASTM D6978-05 (Chemo Permeation) | Resistance against Chemotherapy Drugs (permeation time) | Breakthrough greater than 240 min. for: Blenoxane, Busulfan, Carboplatin, Cisplatin, Cyclophosphamide, Cytarabine, Dacarbazine, Daunorubicin HCl, Docetaxel, Doxorubicin HCl, Epirubicin HCl, Etoposide, Fludarabine, Fluorouracil, Gemcitabine, Idarubicin HCl, Ifosfamide, Irinotecan, Mechlorethamine HCl, Melphalan, Methotrexate, Mitomycin C, Mitoxantrone, Paclitaxel, Rituximab, Trisenox, Vincristine Sulfate. | |
| Breakthrough at 73.7 min. for: Carmustine (Warning: Do not use) | |||
| Breakthrough at 25.4 min. for: ThioTepa (Warning: Do not use) | All tested drugs met or exceeded the specified breakthrough times. (Carmustine and ThioTepa had specific breakthrough times below 240 mins, with warnings not to use). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes for each specific test (e.g., number of gloves tested for dimensions, tensile strength, or chemotherapy permeation). It references specific ASTM and ISO standards for testing, which typically define the appropriate sample sizes and testing methodologies. The data provenance (country of origin, retrospective/prospective) is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable to this type of device submission. The "ground truth" for medical gloves is established by quantitative laboratory testing against defined material and performance standards (ASTM, ISO). There are no human experts judging images or clinical outcomes in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation (e.g., radiology reads) to resolve disagreements. Here, the "truth" is determined by objective physical and chemical testing.
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 is not applicable. MRMC studies are typically performed for AI-powered diagnostic devices that assist human readers. This submission is for a physical medical device (examination glove).
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. There is no algorithm involved; it is a physical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance is based on established industry standards and laboratory testing results. Specifically:
- Dimensions, Physical Properties (Tensile Strength, Elongation), Freedom from Holes, Residual Powder: Defined by the ASTM D6319-10 standard.
- Biocompatibility (Skin Irritation, Dermal Sensitization, Acute Systemic Toxicity): Defined by ISO 10993-10 and ISO 10993-11 standards.
- Resistance against Chemotherapy Drugs: Defined by ASTM D6978-05 standard.
- Open box bioburden: Defined by AAMI 11737-1.
8. The sample size for the training set
This is not applicable. There is no "training set" as this is not an AI/machine learning device. The performance is assessed through direct testing of the product.
9. How the ground truth for the training set was established
This is not applicable as there is no training set.
§ 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.