(129 days)
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
The subject device in this 510(k) Notification is Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs. The subject device is a patient examination glove made from nitrile latex compound, Blue 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. Additionally, the gloves have been tested for biocompatibility and permeability to chemotherapy drugs.
The provided document describes the acceptance criteria and performance of "Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs" manufactured by Shandong Baisheng Medical Products Co., Ltd. (K161944).
Here's an analysis of the requested information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
The device performance is compared against a predicate device (EMG Blue Nitrile Examination Gloves Powder Free with Tested for Use with Chemotherapy Drugs, K141623) and general acceptance criteria based on relevant ASTM standards.
| Characteristics | Acceptance Criteria | Reported Device Performance (Shandong Baisheng Medical Products Co., Ltd.) |
|---|---|---|
| K-Number | N/A (Internal ID) | K161944 |
| Product Code | LZA, LZC | LZA, LZC |
| Intended use | A powder free 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 patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner. |
| Material used | Nitrile | Nitrile |
| Color | Blue | Blue |
| Single use | Single Use | Yes |
| Non Sterile | Non-Sterile | Non-Sterile |
| Dimensions | Overall Length (mm) Min 270mm; Width (± 5mm) Size S = 85mm, Size M = 95mm, Size L = 105mm, Size XL = 115mm; Thickness at Palm (mm) Min; 0.10mm; Thickness at Finger Tip (mm) Min 0.10mm | Meets ASTM D6319-10 |
| Physical properties | Before Ageing: Tensile Strength (MPa) = 14min, Ultimate Elongation (%) = 500min; After Aging at 70°C for 168 hrs @ 100°C for 22 hrs: Tensile Strength (MPa) = 14min, Ultimate Elongation (%) = 400min | Meets ASTM D6319-10 |
| Freedom from pinholes | AQL 2.5 Inspection Level G-1 | Meets ASTM D5151-06 |
| Residual Powder | 240 min | |
| Cyclophosphamide (20mg/ml): Breakthrough time: >240 min | ||
| Doxorubicin Hydrochloride (2.0mg/ml): Breakthrough time: >240 min | ||
| Etoposide (20mg/ml): Breakthrough time: >240 min | ||
| Fluorouracil (50mg/ml): Breakthrough time: >240 min | ||
| Methotrexate (25mg/ml): Breakthrough time: >240 min | ||
| Mitomycin C (0.5 mg/ml): Breakthrough time: >240 min | ||
| Paclitaxel (6mg/ml): Breakthrough time: >240 min | ||
| Thiotepa (10mg/ml): Breakthrough time: 26.9 min | ||
| Vincristine Sulfate (1mg/ml): Breakthrough time: >240 min |
Notes on Chemotherapy Drug Resistance: The document itself highlights: "Please note the following drugs, Carmustine and Thiotepa, have extremely low permeation times of 13.6 and 26.9 minutes, respectively."
2. Sample size used for the test set and the data provenance
The document does not explicitly state a specific "test set" sample size for each performance test in typical terms used for AI/clinical studies. Instead, it refers to standard inspection levels and AQLs for physical properties and details for the chemotherapy drug permeation testing.
- Physical and Dimensions Testing: "Inspection Level S-2, AQL 2.5." This refers to sampling plans defined in quality control standards, not a fixed sample size. The specific sample size would depend on the lot size being tested.
- FDA 1000 ml. Water Fill Test: "samplings of AQL 2.5, Inspection Level I". Similar to above, this is a sampling plan.
- Biocompatibility (Primary Skin Irritation and Skin Sensitization) Testing: No specific sample size is mentioned, but implies in vivo testing (likely on animals or human volunteers for sensitization, but often animal models for irritation).
- Chemotherapy Drug Permeation Testing: No specific number of gloves or replicates is stated in the provided text, but it's done "in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs". This standard would define the methodology and number of test specimens.
Data Provenance: The tests appear to have been performed specifically for the purpose of this 510(k) submission, thus they are prospective for the device's regulatory clearance. The manufacturer is "Shandong Baisheng Medical Products Co., Ltd." located in Linqu, Shandong, China, suggesting the testing was performed, or overseen, in relation to their manufacturing activities.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable as the device is a medical glove, not an AI or diagnostic device that requires expert ground truth for interpretation. The "ground truth" for the performance criteria are objective measurements from laboratory tests following established ASTM standards.
4. Adjudication method for the test set
This is not applicable for the same reasons as #3. No expert adjudication is involved.
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. This document evaluates a medical glove, not an AI assistant or a diagnostic device involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This document evaluates a medical glove.
7. The type of ground truth used
The ground truth for the performance criteria is established through objective laboratory measurements and tests conforming to recognized industry standards (primarily ASTM D6319-10, ASTM D5151-06, and ASTM D6978-05(2013)).
- Physical properties: Measured parameters like tensile strength, elongation, dimensions against the standard's requirements.
- Freedom from pinholes: Based on water leak tests and statistical sampling (AQL).
- Residual Powder: Gravimetric measurement (mg/glove).
- Biocompatibility: Results of specific irritation and sensitization assays/protocols.
- Chemotherapy Drug Permeation: Measured breakthrough time of specific chemotherapy agents through the glove material using analytical methods defined in ASTM D6978.
8. The sample size for the training set
This is not applicable. This document describes the testing of a medical glove, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
This is not applicable for the same reasons as #8.
§ 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.