(49 days)
Powder free Surgeon's glove is a sterile powder free medical device intended to be worn by operating room personnel to protect a surgical wound from contamination.
Class I Powder free Surgical Glove 79KGO that meets all 'the requirements of ASTM D3577.
The provided text describes the acceptance criteria and performance data for a Powder-Free Surgeon's Glove. The study is a standalone performance study to demonstrate that the device meets established standards.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (ASTM D3577 Requirement unless otherwise specified) | Reported Device Performance (SARI Value) | Pass/Fail |
|---|---|---|---|
| Length (5 ½ size) | 245 mm minimum | 270-272 mm | Pass |
| Length (6 size) | 265 mm minimum | 270-272 mm | Pass |
| Length (6 ½ size) | 265 mm minimum | 270-272 mm | Pass |
| Length (7 size) | 265 mm minimum | 270-272 mm | Pass |
| Length (7 ½ size) | 265 mm minimum | 270-272 mm | Pass |
| Length (8 size) | 265 mm minimum | 270-272 mm | Pass |
| Length (8 ½ size) | 265 mm minimum | 270-272 mm | Pass |
| Length (9 size) | 265 mm minimum | 270-272 mm | Pass |
| Width (5 ½ size) | 70 +/- 6 mm | 68 mm | Pass (within range 64-76mm) |
| Width (6 size) | 76 +/- 6 mm | 73 mm | Pass (within range 70-82mm) |
| Width (6 ½ size) | 83 +/- 6 mm | 79 mm | Pass (within range 77-89mm) |
| Width (7 size) | 99 +/- 6 mm | 87 mm | Pass (within range 93-105mm) |
| Width (7 ½ size) | 95 +/- 6 mm | 92 mm | Pass (within range 89-101mm) |
| Width (8 size) | 105 +/- 6 mm | 103 mm | Pass (within range 99-111mm) |
| Width (8 ½ size) | 108 +/- 6 mm | 106 mm | Pass (within range 102-114mm) |
| Width (9 size) | 114 +/- 6 mm | 112 mm | Pass (within range 108-120mm) |
| Thickness (Cuff, Palm, Fingertip) | 0.1 mm minimum | 0.12 mm (cuff), 0.16 mm (palm), 0.19 mm (fingertip) | Pass |
| Tensile Strength (Before Ageing) | 24 mpa | 27 mpa | Pass |
| Elongation at Break % (Before Ageing) | 750% | 850% | Pass |
| Modulus at 500% Elongation (Before Ageing) | 5.5 mpa (max) | 3 mpa | Pass |
| Tensile Strength (After Ageing) | 18 mpa min | 20 mpa | Pass |
| Elongation at Break % (After Ageing) | 560% min | 750% | Pass |
| Sterility | As per USP* | As per IP* | Pass (Implied by meeting IP standards) |
| Freedom from Holes | AQL 1.5 (S4 Level) | AQL 1.5 (S4 Level) | Pass (Stated to meet AQL) |
| Dimension | AQL 4 (S2 Level) | AQL 4 (S2 Level) | Pass (Stated to meet AQL) |
| Physical Property (Tensile strength, Elongation at break) | AQL 4 (S2 Level) | AQL 4 (S2 Level) | Pass (Stated to meet AQL) |
| Powder Content | Not specified in D3577 section, but stated to be 1 +/- 1 mg per glove | 1 +/- 1 mg per Glove | Pass |
| Protein Content | Not specified in D3577 section, but stated to be 80 +/- 20 ppm | 80 +/- 20 ppm | Pass |
| Moisture Content | Not specified in D3577 section, but stated to be 0.8% max | 0.8% max | Pass |
| Biocompatibility | Not specified in D3577 section, but stated to be Biologically Compatible | Biologically Compatible | Pass |
Note: IP (Indian Pharmacopea) and USP (United States Pharmacopeia) are both pharmacopoeial standards for sterility. Meeting IP, along with the claim of meeting or exceeding ASTM D3577, implies acceptable sterility.
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Test Set: The document does not explicitly state the specific number of gloves tested for each characteristic. It refers to "AQL followed" for various performance requirements, implying a sampling plan was used as per ASTM D3577, but the exact number of units sampled or tested is not provided.
- Data Provenance: The data is reported by "Sri.Anusham Rubber Industries Pvt. Ltd." which is located in Nagarcoil, Tamil Nadu, India. The data is retrospective in the sense that it's presented as the results of tests already conducted on their manufactured gloves.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This type of information is not applicable to this study. The ground truth for device performance is established based on objective measurements against quantifiable standards (ASTM D3577) rather than expert consensus on interpretations of complex data like medical images.
4. Adjudication Method for the Test Set
This is not applicable as the determination of whether the device meets the criteria is based on objective, quantitative measurements against a predefined standard (ASTM D3577), not on subjective assessments requiring adjudication.
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 relevant for evaluating the impact of AI on human readers (e.g., radiologists interpreting images) and is not applicable to the performance testing of a physical medical device like a surgeon's glove.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance study was done. The document presents the intrinsic performance of the manufactured gloves against established standards (ASTM D3577 and other specific chemical/physical properties) without involving human operators in a comparative effectiveness setting. The "device" in this context is the glove itself, and its performance is assessed directly.
7. The Type of Ground Truth Used
The ground truth used is based on pre-defined, objective performance standards and specifications from ASTM D3577, as well as internal specifications for powder, protein, and moisture content, and biocompatibility. These are quantifiable criteria used to assess the physical, mechanical, and biological properties of the gloves.
8. The Sample Size for the Training Set
This is not applicable. The device is a physical product (surgeon's glove), not an algorithm or a software AI requiring a "training set" in the machine learning sense. The manufacturing process is designed to consistently produce gloves meeting these specifications.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the reason mentioned in point 8.
§ 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).