(57 days)
Pink Powder Free Nitrile Examination Glove with Bubblegum Scented, Chemotherapy Drugs and Fentanyl test claim 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. It is for over-the-counter use.
In addition, these gloves were tested for use with Chemotherapy drug and Fentanyl test claim in accordance with ASTM D6978-05 standards Practice for assessment of Medical Glove to Permeation by chemotherapy drug and Fentanyl test claim
The subject device in this 510(k) Notification is Pink Powder Free Nitrile Examination Glove with Bubblegum Scented, Chemotherapy Drugs and Fentanyl test claim. The subject device is a patient examination glove made from nitrile compound, pink color, powder free and non-sterile (Per 21 CFR 880.6250, class I). The device meets all the specifications in ASTM D6319-10, Standard specification for Nitrile Examination Gloves.
This document is a 510(k) premarket notification for a medical device: "Pink Powder Free Nitrile Examination Glove with Bubblegum Scented, Chemotherapy Drugs and Fentanyl Test Claim." Since this is a glove, the criteria are focused on physical and chemical properties and safety, not on diagnostic accuracy of an AI model. Therefore, many of the requested categories related to AI performance, such as MRMC studies, expert adjudication, training sets, and data provenance in a diagnostic sense, are not applicable.
Below is the information derived from the provided document, tailored to the context of a medical glove.
1. Table of Acceptance Criteria and Reported Device Performance
The device performance was evaluated against ASTM standards and specific chemical resistance criteria.
| Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dimensions | ||
| Overall Length | Min 230mm | Meets ASTM D6319-10 (implying >230mm for all sizes) |
| Width | Size S = 85±5mm; Size M = 95±5mm; Size L = 105±5mm; Size XL = 115±5mm | Meets ASTM D6319-10 (specific widths 85mm, 95mm, 105mm, 115mm) |
| Thickness | Palm: Min 0.05 mm; Finger Tip: Min 0.05 mm | Meets ASTM D6319-10 (implying >0.05mm at palm and finger) |
| Physical Properties | ||
| Before Ageing | Tensile Strength (MPa) = ≥14min; Ultimate Elongation (%) = ≥500min | Meets ASTM D6319-10 |
| After Ageing | Tensile Strength (MPa) = ≥14min; Ultimate Elongation (%) = ≥400min (at 70℃ for 168 hrs / 100℃ for 22 hrs) | Meets ASTM D6319-10 |
| Pin-hole Level | AQL 2.5, Inspection Level G-1 | Meets ASTM D5151-06 (AQL 2.5, Inspection Level G-1) by FDA 1000ml water leak test |
| Residual Powder | ≤ 2.0 mg/pc | Meets ASTM D6124-06 (240 minutes |
| 3) Cytarabine HCI (100mg/ml) | ≥ 0 minutes (based on predicate which was 0 minutes, but new claims >240 minutes) | >240 minutes |
| 4) Doxorubicin HCI (2.0mg/ml) | >240 minutes | >240 minutes |
| 5) Etoposide (20.0mg/ml) | >240 minutes | >240 minutes |
| 6) Fluorouracil (50.0mg/ml) | >240 minutes | >240 minutes |
| 7) Methotrexate (25mg/ml) | >240 minutes | >240 minutes |
| 8) Paclitaxel (6.0mg/ml) | >240 minutes | >240 minutes |
| 9) ThioTepa (10.0mg/ml) | ≥ 30.2 minutes (based on predicate) | 34.8 minutes |
| 10) Fentanyl Citrate Injection 100mg/2ml | >240 minutes | >240 minutes |
2. Sample size used for the test set and data provenance
- Sample Size for Physical/Chemical Testing:
- For Freedom from Pin holes (AQL 2.5): ISO 2859-1/ G1 inspection level. The specific numerical sample size is not explicitly stated but is determined by the AQL and inspection level, which is a standard sampling plan for quality control in manufacturing.
- For Dimensions (AQL 4.0): ISO 2859-1/ S2 inspection level.
- For Physical properties (AQL 4.0): ISO 2859-1/ S2 inspection level.
- For Powder-free residue: N=5 gloves tested.
- For Biocompatibility: The exact number of samples (animals or cell cultures) used for biocompatibility testing is not specified in this summary but generally follows ISO 10993 guidelines.
- For Chemotherapy Drugs and Fentanyl Permeation: The specific sample size for each drug test is not explicitly stated in this document but these tests typically involve multiple glove samples.
- Data Provenance: The tests were conducted by Riverstone Resources Sdn Bhd, a Malaysian company. The data is retrospective (i.e., tests were completed before 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. This device is a medical glove, and "ground truth" as it relates to expert clinical assessments for diagnostic algorithms is not relevant here. The "ground truth" for the performance criteria is established by adherence to recognized international standards (ASTM, ISO) for physical, chemical, and biological properties.
4. Adjudication method for the test set
Not applicable. The testing involves standardized laboratory methods and measurements, not subjective interpretation requiring adjudication among experts.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
Not applicable. MRMC studies are used for evaluating the diagnostic performance of imaging devices or AI algorithms by comparing multiple human readers' interpretations of cases. This is a physical device (glove), not a diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm. The performance tests are for the physical and chemical properties of the glove itself.
7. The type of ground truth used
The "ground truth" is based on:
- Standardized Test Methods: Adherence to established international standards such as ASTM D6319-10 (Standard specification for Nitrile Examination Gloves), ASTM D5151-06 (Freedom from Pinholes), ASTM D6124-06 (Powder-free residue), ASTM D6978-05 (Chemotherapy drug permeation), and ISO 10993 series (Biocompatibility).
- Predicate Device Performance: For chemotherapy drug permeation, the performance of the predicate device (K192954) also serves as a benchmark for comparison.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. 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.