(217 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 D35 77 -09(2015), 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 additive 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 document is a 510(k) premarket notification for a medical device: "Sterile Latex Surgical Gloves Powder Free." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel clinical effectiveness. As such, the information you've requested regarding acceptance criteria and study details for an AI/ML-based device is not entirely applicable to this document.
However, I can extract the closest equivalent information from the given text, focusing on the performance criteria by which the device's substantial equivalence was established.
Here's the breakdown based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document provides a detailed comparison of the subject device (Nulife / Sterile Latex Surgical Gloves Powder Free) against the predicate device (JR Medic Latex Surgeon's Gloves Sterile Powder Free) and references relevant ASTM and ISO standards for acceptance criteria.
| Criteria | Specification as per Standard (Acceptance Criteria) | Reported Device Performance (Subject Device K210969) | Predicate Device Performance (K192328) |
|---|---|---|---|
| Length (various sizes) | Min 245mm (Size 5.5), Min 265mm (Sizes 6-9) | 483mm - 487mm | 300 mm |
| Width (various sizes) | 70+/-6mm to 114+/-6mm | 71mm - 116mm | 78mm - 116mm (for corresponding sizes) |
| Finger Thickness (All sizes) | Min 0.10mm | 0.32mm | 0.21mm |
| Palm Thickness (All sizes) | Min 0.10mm | 0.20mm | 0.18mm |
| Cuff Thickness (All sizes) | Min 0.10mm | 0.15mm | 0.11mm |
| Tensile Strength (Before aging, All sizes) | 24Mpa minimum | 28.32Mpa | 26.0Mpa |
| Tensile Strength (After aging, All sizes) | 18Mpa minimum | 23.21Mpa | 22.0Mpa |
| Ultimate Elongation (Before aging, All sizes) | 750% minimum | 869% | 860% |
| Ultimate Elongation (After aging, All sizes) | 560% minimum | 730% | 725% |
| Stress at 500% (Before aging, All sizes) | 5.5 MPa Max | 5.1Mpa | 2.7 Mpa |
| Pinhole AQL (Before aging, All sizes) | Max 1.5 | 1.0 | 1.0 |
| Pinhole AQL (After aging, All sizes) | Max 1.5 | 1.0 | 1.0 |
| Powder residue (for powder free glove) | ) | Non pyrogenic | Non pyrogenic |
| Acute Systemic Toxicity | No systemic toxicity concern (ISO 10993-11) | Under the conditions of study, the device extracts do not pose a systemic toxicity concern | No data available |
| 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).