(197 days)
A Sterile Latex Surgical Gloves Powder Free is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
The proposed device, Sterile Latex Surgical Gloves Powder Free with protein content labeling claim of 50 µg/ dm² or less per glove of extractable protein is a sterile and disposable medical glove intended to be worn by operating room personnel to protect a surgical wound from contamination. The proposed device is made of natural rubber latex, as per standard ASTM D3577-2019, Standard Specification for Rubber Surgical Gloves. The classification is: Type I - gloves compounded primarily from natural rubber latex. The proposed device is Sterile Latex Surgical Gloves Powder Free, and variants of different sizes. All variants share the same natural color (No Color is added). The proposed device is sterilized using Gamma and ETO method to achieve the Sterility Assurance Level (SAL) of 10 and place in a sterility maintained package to ensure a shelf life of 5years.
The provided text describes the acceptance criteria and the study that proves the device meets those criteria for Sterile Latex Surgical Gloves Powder Free (K212596), intended to be worn in operating rooms. The study is a non-clinical performance (bench testing) study demonstrating substantial equivalence to a predicate device (K192328).
Here's the breakdown of the information requested, based on the provided document:
Acceptance Criteria and Device Performance Study for Sterile Latex Surgical Gloves Powder Free (K212596)
The study performed is a non-clinical performance (bench testing) study, as explicitly stated under "SUMMARY OF NONCLINICAL PERFORMANCE DATA" and "SUMMARY OF CLINICAL PERFORMANCE DATA: Clinical data was not required for this submission." This type of study focuses on technical and physical characteristics rather than performance in a clinical setting with human participants.
1. Table of Acceptance Criteria and the Reported Device Performance
The acceptance criteria are generally based on ASTM D3577-2019, Standard Specification for Rubber Surgical Gloves, and other specific standards for each test.
| Characteristic | Acceptance Criteria (Standard) | Reported Device Performance (Average Value of Subject Device) | Met Acceptance Criteria? |
|---|---|---|---|
| Dimensions | ASTM D3577-2019 | ||
| Length (All sizes) | Min 265 mm | Varies by size (e.g., Size 7: 486 mm, Size 9: 488 mm) | Yes |
| Width (e.g., Size 7) | 89 ± 6 mm | 91 mm | Yes |
| Finger Thickness (All sizes) | Min 0.10 mm | 0.33 mm | Yes |
| Palm Thickness (All sizes) | Min 0.10 mm | 0.21 mm | Yes |
| Cuff Thickness (All sizes) | Min 0.10 mm | 0.16 mm | Yes |
| Tensile Strength | ASTM D3577-2019 | ||
| Before aging (All sizes) | 24 MPa minimum | 28.61 MPa | Yes |
| After aging (All sizes) | 18 MPa minimum | 24.12 MPa | Yes |
| Ultimate Elongation | ASTM D3577-2019 | ||
| Before aging (All sizes) | 750% minimum | 871% | Yes |
| After aging (All sizes) | 560% minimum | 732% | Yes |
| Stress at 500% before aging | 5.5 MPa Max | 5.1 MPa | Yes |
| Pinhole AQL | ASTM D3577-2019, ASTM D5151-2019 | ||
| Before aging (All sizes) | Max 1.5 | 1.0 | Yes |
| After aging (All sizes) | Max 1.5 | 1.0 | Yes |
| Freedom from Holes AQL | AQL 1.0 (ASTM D3577-2019, ASTM D5151-2019) | 1.0 | Yes |
| Powder Residue | `) | Non-pyrogenic | Yes |
| Systemic Toxicity | Device extracts do not pose a systemic toxicity concern (ISO 10993-11) | Device extracts do not pose a systemic toxicity concern | Yes |
| Bacterial Endotoxin | `) |
§ 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).