(69 days)
The gloves are intended to be worn on the hand of healthcare personnel, operating room personnel and similar personnel to prevent contamination between the healthcare or similar personnel and the patient's body, fluids, waste, or environment.
The surgeon's glove is a device made of natural rubber intended to be worn by surgeons and/or operating room personnel to protect a surgical wound from contamination.
Class I natural rubber latex surgeon's glove, 79 KGO, powder free, protein content labeling. It meets all of the requirements of ASTM standard D3577-99.
Here's an analysis of the acceptance criteria and the study proving device performance, based on the provided document:
This document is a 510(k) premarket notification for a medical device, specifically a surgical glove. As such, the "study" described is a set of performance tests designed to demonstrate that the device meets established industry standards and regulatory requirements, thereby proving substantial equivalence to previously marketed devices. It is not a clinical "comparative effectiveness study" or "standalone algorithm performance study" in the typical sense for AI/machine learning devices.
1. Table of Acceptance Criteria and Reported Device Performance
The device is a "DERMAGRIP POWDER FREE LATEX SURGICAL GLOVE, STERILE (PROTEIN CONTENT LABELING)". The acceptance criteria are based on ASTM D 3577-99 (Standard Specification for Rubber Surgical Gloves) and the FDA 1000 ml watertight test.
| TEST | Acceptance Criteria (ASTM D 3577-99) | Reported Device Performance (DERMAGRIP Powder Free Latex Surgical Glove, Sterile) |
|---|---|---|
| 1. Watertightness | GI, AQL 1.5 | Pass based on: 1) Single Sampling Plan, GI, AQL 1.5; 2) Multiple Sampling Plan, GII, AQL 2.5 |
| 2. Length (mm) | ||
| 5½ | min 245 | 294 |
| 6 | min 265 | 300 |
| 6½ | min 265 | 298 |
| 7 | min 265 | 309 |
| 7½ | min 265 | 291 |
| 8 | min 265 | 308 |
| 8½ | min 265 | 304 |
| 9 | min 265 | 301 |
| 3. Palm Width (mm) | ||
| 5½ | 70 ± 6 | 72 |
| 6 | 76 ± 6 | 77 |
| 6½ | 83 ± 6 | 83 |
| 7 | 89 ± 6 | 90 |
| 7½ | 95 ± 6 | 98 |
| 8 | 102 ± 6 | 102 |
| 8½ | 108 ± 6 | 108 |
| 9 | 114 ± 6 | 114 |
| 4. Single Wall Thickness (mm) | ||
| Finger | min 0.10 | 0.27 |
| Palm | min 0.10 | 0.24 |
| Cuff | min 0.10 | 0.20 |
| 5. Physical Properties | ||
| Before Aging: | ||
| Tensile Strength (MPa) | min 24 | 29.58 |
| Ultimate Elongation (%) | min 750 | 902 |
| Stress at 500% Elongation (MPa) | max 5.5 | 2.95 |
| After Aging: | ||
| Tensile Strength (MPa) | min 18 | 22.92 |
| Ultimate Elongation (%) | min 560 | 902 |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the exact sample sizes (number of gloves) for each physical test (length, width, thickness, tensile strength, elongation, stress at 500% elongation). However, for the watertightness test, it mentions "Single Sampling Plan, GI, AQL 1.5" and "Multiple Sampling Plan, GII, AQL 2.5". These are quality control sampling plans defined in standards like ISO 2859-1, which specify sample sizes and acceptance/rejection numbers based on lot size and AQL (Acceptable Quality Level). The specific sample size would depend on the lot size from which the gloves were sampled, which is not provided.
Data Provenance: The testing was conducted by "WRP Specialty Products Sdn Bhd" which is located in Sepang, Selangor Darul Ehsan, MALAYSIA. The data is retrospective in the sense that these tests were performed on manufactured gloves prior to this submission for regulatory clearance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This type of device does not involve human expert interpretation or ground truth establishment in the way AI/ML systems do. The performance data is based on objective physical measurements and standardized test methods (ASTM D 3577-99 and FDA 1000 ml watertight test) performed by laboratory personnel. Therefore, no "experts" in that specific sense were used to establish ground truth for the test set.
4. Adjudication Method for the Test Set
Not applicable for this type of device testing. Adjudication methods (e.g., 2+1) are typically used for subjective assessments (e.g., image interpretation) where there might be disagreement between observers. The tests for this device involve objective measurements against predefined criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This is not a software device or an AI/ML system that would involve human readers interacting with an algorithm. The submission focuses on the physical and chemical properties of a medical device (surgical glove).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone performance study (in the context of an algorithm) was not done. This is a physical product, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by objective physical and chemical measurement standards defined in ASTM D 3577-99 and the FDA 1000 ml watertight test. For example:
- Watertightness: Defined by the absence of leaks when subjected to the specified water volume and time.
- Dimensions (Length, Palm Width, Thickness): Measured according to standard protocols and compared to specified minimums/ranges.
- Physical Properties (Tensile Strength, Elongation, Stress at 500% Elongation): Measured using standardized equipment (e.g., tensile tester) and compared against specified minimums/maximums, both before and after accelerated aging.
8. The Sample Size for the Training Set
Not applicable. This device is not a machine learning model, so there is no concept of a "training set" in this context. The manufacturing process itself (which is subject to Good Manufacturing Practices) can be seen as "training" in a very broad sense, ensuring consistent product quality, but it's not a dataset for an algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an algorithm.
§ 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).