(107 days)
This glove is intended to be worn by operating room personnel to protect a surgical wound from contamination. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05(Reapproved 2019).
Sterile Polyisoprene Powder Free Surgical Glove, tested for Use with Chemotherapy Drugs is a disposable singleuse, sterile, Cream-colored and powder-free surgical glove made from synthetic polyisoprene latex.
This document describes the premarket notification (510(k)) for a medical device – "Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy Drugs." This device is a Class I, reserved product, meaning it's subject to general controls but does not require extensive clinical data for approval if it demonstrates substantial equivalence to a legally marketed predicate device.
The provided text focuses on the device's technical specifications and non-clinical testing to demonstrate substantial equivalence to a predicate device, not on proving an AI algorithm's performance in a diagnostic context. Therefore, many of the requested elements for describing an AI acceptance criteria study (e.g., sample size for test set, data provenance, expert ground truth, MRMC study, effect size, standalone performance, training set details) are not applicable to this submission.
The "acceptance criteria" here refer to the product's physical, chemical, and performance standards as determined by established industry and regulatory test methods, not diagnostic performance metrics of an AI.
Here's an interpretation of the "acceptance criteria" and "study" based on the provided document:
Acceptance Criteria and Reported Device Performance
The device's performance is demonstrated through adherence to various ASTM and ISO standards. The acceptance criteria are the minimum or maximum values specified by these standards, and the reported device performance indicates whether the tested product met these thresholds.
| Characteristic | Acceptance Criteria (Standard/Guidance) | Reported Device Performance | Conclusion |
|---|---|---|---|
| Dimensions | ASTM D3577-19 | Meets ASTM D3577 requirements for length, width, and thickness | Pass |
| Length | Minimum 265mm | 280-305mm | Pass |
| Palm Width (size) | Various (70±6mm to 114±6mm) | Average values within range (e.g., 73mm for size 5.5, 114mm for size 9.0) | Pass |
| Thickness (Finger, Palm, Cuff) | Minimum 0.10 mm | Finger: 0.22-0.24 mm, Palm: 0.22 mm, Cuff: 0.17-0.18 mm | Pass |
| Physical Properties | ASTM D3577-19 | Meets ASTM D3577-19 | Pass |
| Tensile Strength, Before Aging | ≥ 17 MPa | Average 20-21 MPa | Pass |
| Ultimate Elongation, Before Aging | ≥ 650 % | Average 780-823 % | Pass |
| Stress at 500% Elongation | 7.0 MPa, max | Average 2.5-3.1 MPa | Pass |
| Tensile Strength, After Accelerated Aging | ≥ 12 MPa | Average 18-20 MPa | Pass |
| Ultimate Elongation, After Accelerated Aging | ≥ 490 % | Average 747-809 % | Pass |
| Freedom from holes | ASTM D3577-19, ASTM D 5151-19 (AQL 1.5) | Meets AQL 1.5 | Pass |
| Powder-Free | ASTM D3577-19, ASTM D 6124-06(2022) (≤ 2 mg per glove) | 0.10-0.27 mg per glove | Pass |
| Aqueous Extractable Protein Content | ASTM D3577-19, ASTM D5712-15 (≤ 200 ug/dm2) | ≤ 50 ug/dm2 | Pass |
| Sterility | 10-6 SAL | 10-6 SAL | Pass |
| Biocompatibility | ISO 10993 standards (10, 23, 5, 11) | Results indicate compliance or acceptable levels | Pass |
| Skin Sensitization Test | No significant evidence of causing skin sensitization | No significant evidence of causing skin sensitization | Pass |
| Intracutaneous Reactivity Test | Score |
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).