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510(k) Data Aggregation
(77 days)
These gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination in environments within hospitals and other healthcare facilities. These gloves are appropriate for use during invasive as well as non-invasive medical procedures requiring sterility.
Esteem Blue Polyisoprene Surgical Gloves with coating are formulated using Synthetic Rubber Latex. These are offered powder-free and sterile.
This document describes acceptance criteria and testing for the Esteem Blue Polyisoprene Surgical Gloves with Coating.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test/Characteristic | Acceptance Criteria (Set by Regulations/Standards) | Reported Device Performance |
|---|---|---|
| Primary Skin Irritation | Not explicitly stated in the provided text, but implied as "non-irritating" for safe use. | Gloves are non-irritating. |
| Guinea Pig Maximization | Not explicitly stated in the provided text, but implied as not causing sensitization for safe use. | Gloves do not display any potential for sensitization. |
| Ultimate Elongation & Tensile Strength | Exceed requirements for rubber surgical gloves per ASTM D3577-01a2. | Gloves exceed requirements for rubber surgical gloves per ASTM D3577-01a2. |
| Barrier Defects | Exceed requirements per 21 CFR §800.20 and ASTM D3577-01a2, with an Acceptance Quality Limit (AQL) of 1.5. | Gloves exceed requirements per 21 CFR §800.20 and ASTM D3577-01a2, AQL = 1.5. |
| Powder Level | Meet powder level requirements for "Powder Free" designation using ASTM Standard D6124-01 (implied < 2 mg per glove). | Gloves meet powder level requirements for "Powder Free" designation using ASTM Standard D6124-01-Standard test method for residual powder on medical gloves. Results generated values below 2 mg of residual powder per glove. (This is the specific numerical acceptance criteria). |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria is detailed in the "Summary of Testing" section of the 510(k) submission. It consists of multiple tests performed on the Esteem Blue Polyisoprene Surgical Gloves with Coating.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The provided document does not explicitly state the specific sample sizes used for each individual test (e.g., number of gloves tested for barrier defects, number of guinea pigs for sensitization). It reports the results of these tests against established standards.
- Data Provenance: The data is likely prospective as these tests are part of a premarket notification (510(k)) process, meaning they were conducted specifically to demonstrate the safety and effectiveness of this new device before it entered the market. The country of origin of the data is not specified, but the submission is for the USA FDA, implying the tests were conducted according to US regulatory standards, which usually means within or for a US-based submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
Not applicable. This document pertains to the performance testing of a physical medical device (surgical gloves) against established engineering and biological standards, not diagnostic device performance requiring expert-derived ground truth. The "ground truth" here is objective measurement against specified criteria in standards like ASTM and CFR.
4. Adjudication Method for the Test Set:
Not applicable. As noted above, this relates to objective physical and biological testing, not diagnostic assessments requiring consensus or adjudication among experts. The results are based on direct measurements and observations compared to pre-defined thresholds within the specified standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices or AI-assisted diagnostic tools to assess how human readers' performance (e.g., accuracy, efficiency) is affected by the AI. This document concerns the physical and biological properties of surgical gloves, which do not involve human readers interpreting cases.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Not applicable. This is not an AI/algorithm-based device. The "standalone" performance refers to the intrinsic physical and biological qualities of the glove itself.
7. The Type of Ground Truth Used:
The "ground truth" for the performance evaluation of these surgical gloves is based on:
- Established Regulatory Standards: For barrier defects (21 CFR §800.20).
- Consensus Industry Standards: For ultimate elongation & tensile strength (ASTM D3577-01a2), barrier defects (ASTM D3577-01a2), and powder level (ASTM D6124-01).
- Standardized Biological Safety Tests: For primary skin irritation and guinea pig maximization, where "non-irritating" and "no sensitization potential" are the accepted outcomes.
These standards define the objective and measurable criteria that the device must meet.
8. The Sample Size for the Training Set:
Not applicable. This is a physical medical device, not a machine learning model. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As there is no training set for a machine learning model, there is no ground truth to establish for such a set.
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