(126 days)
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs.
The subject device is single use, disposable gloves intended for medical purposes to be worn on the examiner's hands to prevent contamination between patient and examiner. The gloves are powder-free, ambidextrous with beaded cuff, blue colored, nitrile, and tested for use with chemotherapy drugs. The gloves are offered in four sizes: small, medium, large, and extra-large. The subject device is non-sterile.
The provided text describes the acceptance criteria and the study that proves the device, Disposable nitrile rubber protective gloves (Tested for Use with Chemotherapy Drugs), meets those criteria.
Here's the information extracted and formatted as requested:
1. Table of acceptance criteria and the reported device performance:
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test | Length (mm): S:≥220; M/L/XL:≥230; Width (mm): S: 80±10; M: 95±10; L: 110±10; XL: 120±10; Thickness (mm): Finger: ≥0.05; Palm: ≥0.05 | Length (mm): ≥ 230/Pass; Width (mm): S: 85-89 /Pass; M: 94-97/ Pass; L: 100-104/ Pass; XL:110-113/ Pass; Thickness (mm): Finger: 0.16-0.18/Pass; Palm: 0.11-0.12/Pass |
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 | 0/125/Pass |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 2.0mg | 0.15-0.19mg/Pass |
| ASTM D412 | Physical properties (Tensile Strength) | Before Aging: Tensile Strength ≥14MPa; Ultimate Elongation ≥500%; After Aging: Tensile Strength ≥14MPa; Ultimate Elongation ≥400% | Before Aging: 16.5-33.1MPa/Pass; 500-585%/Pass; After Aging: 14.1-28.3MPa/Pass; 482-555%/Pass |
| ISO 10993-5 | Cytotoxicity | Non-cytotoxic | Under conditions of the study, device extract is cytotoxic (Note: This is a discrepancy identified in the document, but the device was still cleared based on other testing) |
| ISO 10993-11 | Acute systemic toxicity | Non-acute systemic toxicity | Under conditions of the study, did not show acute systemic toxicity in vivo / Pass |
| ISO 10993-10 | Irritation | Non-irritating | Under the conditions of the study, not an irritant/ Pass |
| ISO 10993-10 | Sensitization | Non-sensitizing | Under conditions of the study, not a sensitizer./ Pass |
| ASTM D6978-05 | Chemotherapy Drug Permeation (Breakthrough Detection Time) | - | Carmustine (BCNU) 3.3 mg/ml: 33.5 Minutes; Cisplatin 1.0 mg/ml: > 240 Minutes; Cyclophosphamide 20.0 mg/ml: > 240 Minutes; Dacarbazine 10.0 mg/ml: > 240 Minutes; Doxorubicin HCl 2.0 mg/ml: > 240 Minutes; Etoposide 20.0 mg/ml: > 240 Minutes; Fluorouracil 50.0 mg/ml: > 240 Minutes; Paclitaxel 6.0 mg/ml: >240 Minutes; Thio Tepa 10.0 mg/ml: 62.6 Minutes. Warning: Please do not use with Carmustine (BCNU) and Thiotepa. |
2. Sample size used for the test set and the data provenance:
- Sample size for Watertightness Test (ASTM D5151): 125 gloves (indicated by "0/125/Pass").
- Data provenance: Not explicitly stated, but based on the context of a 510(k) submission, this would be data generated by the manufacturer from laboratory testing (bench testing) of their product. It is inherently retrospective as the testing precedes the 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 the acceptance criteria are based on standardized physical and chemical performance tests rather than expert interpretation of medical images or patient data. The "ground truth" is defined by the objective measurements and pass/fail criteria of the ASTM and ISO standards.
4. Adjudication method for the test set:
- Not applicable. The tests are objective measurements against defined standards, not subjective assessments requiring expert adjudication.
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-powered diagnostic device, but a medical glove. MRMC studies are used for evaluating diagnostic performance with and without AI assistance for human readers of medical images.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI algorithm.
7. The type of ground truth used:
- The ground truth is established by objective measurements against established international standards (ASTM and ISO) for physical properties, barrier integrity, biocompatibility, and chemical permeation.
8. The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. No training set is used for this 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.