(127 days)
The Single-Use Latex Sterile Surgical Gloves are device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
The proposed device, Single-Use Latex Sterile Surgical Gloves is a sterilized 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, per standard ASTM D3577- 09(15), the rubber surgical gloves classification is: Type 1-qloves compounded primarily from nature rubber latex." The qloves are powderfree and available in white in sizes 6, 6.5, 7, 7.5, 8, 8.5 and 9. The proposed device is provided Radiation sterilized to achieve the sterility Assurance Level (SAL) of 10-6. The latex surgical glove shelf life is 3 years.
This document is a 510(k) Pre-market Notification for a medical device, specifically Single-Use Latex Sterile Surgical Gloves (SG100). It focuses on demonstrating substantial equivalence to a predicate device, not necessarily a comprehensive study proving novel effectiveness.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document presents two tables relevant to acceptance criteria and device performance:
Table 1: Comparison of Technological Characteristics (Proposed vs. Predicate) - This table indirectly shows performance against standards and similarities with the predicate.
| Characteristic | Acceptance criteria of the standard (Implied or Explicit) | Proposed device K231446 | Predicate device K212848 | Remarks |
|---|---|---|---|---|
| Product name | N/A (Comparison, not an acceptance criterion) | Single-Use Latex Sterile Surgical Gloves | Sterile Latex Surgical Gloves Powder Free | Similar |
| Indications For Use | N/A (Comparison, not an acceptance criterion) | To protect surgical wound from contamination | To protect surgical wound from contamination | Similar |
| Product Code | KGO | KGO | KGO | Same |
| Regulation Number | 21 CFR 878.4460 | 21 CFR 878.4460 | 21 CFR 878.4460 | Same |
| Powdered or Powder free | Powdered free | Powdered free | Powdered free | Same |
| Classification as per ASTM D3577-2019 | Type I - gloves compounded primarily from natural rubber latex | Type I - gloves compounded primarily from natural rubber latex | Type I - gloves compounded primarily from natural rubber latex | Same |
| Type of use | Over the counter use | Over the counter use | Over the counter use | Same |
| Shelf Life | 3 Years | 3 Years | 3 Years | Same |
| Sterilization | Radiation, SAL- 10-6 | Radiation, SAL- 10-6 | Radiation, SAL- 10-6 | Same |
| Single use | Yes | Yes | Yes | Same |
| Label and Labeling | Meet FDA's Requirement | Meet FDA's Requirement | Meet FDA's Requirement | Same |
| Protein Content | N/A (Comparison, predicate has a lower value, but both meet ) |
§ 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).