(127 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 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 -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 is added). The proposed device is sterilized using Gamma method to achieve the Sterility Assurance Level (SAL) of 10 and place in a sterility maintained package to ensure a shelf life of 3 years.
The provided document is a 510(k) Premarket Notification for a medical device: "Sterile Latex Surgical Gloves powder free." This document focuses on demonstrating substantial equivalence to an existing predicate device, rather than proving the device meets clinical acceptance criteria for an AI/ML medical device. Therefore, many of the requested points related to AI/ML study design (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth for training set) are not applicable to this type of submission.
However, the document does contain information about performance testing against established standards, which serve as the acceptance criteria for this specific device.
Here's an analysis of the provided information, addressing the relevant points and noting those that are not applicable:
Device Name: Sterile Latex Surgical Gloves powder free
Submission Type: 510(k) Premarket Notification (for substantial equivalence)
1. A table of acceptance criteria and the reported device performance
The document provides extensive tables comparing the subject device's performance to the predicate device and against the specifications outlined in relevant ASTM standards. These standards define the "acceptance criteria" for the physical and chemical properties of surgical gloves.
Summary Table of Acceptance Criteria and Reported Performance (Selected Key Parameters)
| Criteria Category | Performance Criterion Source (Standard/Section) | Acceptance Criteria | Reported Device Performance (K211478) | Proof of Meeting Criteria |
|---|---|---|---|---|
| Physical Dimensions | ASTM D3577-09 (Reapproved 2015) | Min 265mm (Length, all sizes) | 385mm - 396mm (All sizes) | Met |
| ASTM D3577-09 (Reapproved 2015) | Various +/- 6mm (Width, per size) | 74mm - 116mm (All sizes) | Met | |
| ASTM D3577-09 (Reapproved 2015) | Min 0.10mm (Finger Thickness, all sizes) | 0.20mm | Met | |
| ASTM D3577-09 (Reapproved 2015) | Min 0.10mm (Palm Thickness, all sizes) | 0.15mm | Met | |
| ASTM D3577-09 (Reapproved 2015) | Min 0.10mm (Cuff Thickness, all sizes) | 0.12mm | Met | |
| Physical Properties | ASTM D3577-09 (Reapproved 2015) | 24 Mpa minimum (Tensile Strength, Before Aging) | 27.2 Mpa - 29.7 Mpa | Met |
| ASTM D3577-09 (Reapproved 2015) | 18 Mpa minimum (Tensile Strength, After Aging) | 22.1 Mpa - 24.5 Mpa | Met | |
| ASTM D3577-09 (Reapproved 2015) | 750% minimum (Ultimate Elongation, Before Aging) | 864% - 874% | Met | |
| ASTM D3577-09 (Reapproved 2015) | 560% minimum (Ultimate Elongation, After Aging) | 727% - 734% | Met | |
| ASTM D3577-09 (Reapproved 2015) | 5.5 MPa Max (Stress at 500% before ageing) | 5.1 Mpa (Average Value) | Met | |
| Barrier Integrity | ASTM D3577-09 & ASTM D5151-06 | Max 1.5 AQL (Pinhole AQL, Before & After Aging) | 1.0 AQL (Gloves Passes) | Met |
| Chemical Residues | ASTM D6124-06 | $\le$ 2 mg/Glove (Powder Residue) | 0.26 mg/glove - 0.62 mg/glove (All sizes) | Met |
| ASTM D3577 & ASTM D5712-15 | $\le$ 50µg/dm² (Protein Content) | 38 µg/dm² | Met | |
| Biocompatibility | ISO 10993-10 | Non-irritant | Non-irritant | Met |
| ISO 10993-10 | Non-sensitizer | Non-sensitizer | Met | |
| ISO 10993-5:2009 | Non-cytotoxic | Cytotoxic | NOT Met (Qualified) | |
| ISO 10993-11:2017 | No systemic toxicity concern | No systemic toxicity concern | Met | |
| ISO 10993-11:2017 / USP 41 | No material mediated pyrogenicity response | No material mediated pyrogenicity response | Met | |
| USP 42 | NMT 20 EU/pair of gloves (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).