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A latex surgeon's glove 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, Latex Surgeon's Gloves (Powdered and Powder Free) 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 D3577-0961, the rubber surgical gloves classification is: "Type I - gloves compounded primarily from natural rubber latex". The proposed device includes Powdered and Powder Free Latex Surgeon's Gloves, and variations of different size. All variations share the same color, creamy white. The proposed device is provided radiation sterilized to achieve the Sterility Assurance Level (SAL) of 10-6 and place in a sterility maintenance package to ensure a shelf life of 3 years.
This document describes the performance testing for "Annuy Latex Surgeon's Gloves (Powdered and Powder Free)" to demonstrate substantial equivalence to a predicate device (K130301). The study is a non-clinical bench test study.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The device performance is compared against various ASTM and ISO standards. The tables below summarize the acceptance criteria (standards) and the reported device performance for both powdered and powder-free gloves.
For Powdered Latex Surgeon's Gloves:
| Characteristics | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimension (ASTM 3577-09e1) | ||
| Palm width | Size 6: 76±6 mm, 6 1/2: 83±6 mm, 7: 89±6 mm, 7 1/2: 95±6 mm, 8: 102±6 mm, 8 1/2: 108±6 mm, 9: 114±6 mm | Size 6: 76 |
| Overall Length | 265 mm min | Size 6: 267 |
| Finger Thickness | 0.10 mm min | 0.10~0.13 mm range across sizes (All reported values meet or exceed the minimum) |
| Palm Thickness | 0.10 mm min | 0.10~0.13 mm range across sizes (All reported values meet or exceed the minimum) |
| Cuff thickness | 0.10 mm min | 0.10~0.13 mm range across sizes (All reported values meet or exceed the minimum) |
| Physical Properties (ASTM 3577-09e1) | ||
| - Tensile Strength (Before Aging) | 24 MPa, min | Reported values for Powdered Gloves are not explicitly listed in the "Test Data" column, but the "Substantially Equivalent Comparison Conclusion" table confirms "Meets ASTM D3577-09e1" and lists the same acceptance criteria as the predicate. The overall conclusion states tests "demonstrated that the proposed device complies with the following standards". |
| - Ultimate Elongation (Before Aging) | 750% min | Same as above. |
| - Stress at 500% Elongation | 5.5 MPa, max | Same as above. |
| - Tensile Strength (After Aging) | 18 MPa, min (at 70±2 °C, 166±2 hrs) | Same as above. |
| - Ultimate Elongation (After Aging) | 560% min (at 70±2 °C, 166±2 hrs) | Same as above. |
| Freedom from Holes (ASTM D5151-11) | Standard Acceptance Criteria: Holes at Inspection Level I, AQL 1.5 | Passed Standard Acceptance Criteria: Holes at Inspection Level I, AQL 1.5 |
| Powder Amount (ASTM D6124-11) | ≤ 15 mg/dm² | 1.43 mg/dm², Meets ASTM D6124-06 (Reapproved 2011), Results generated values below 15 mg/dm² of Powder amount. |
| Protein Content (ASTM D5712-10) | ≤ 200 µg/dm² Aqueous extractable protein | Aqueous extractable protein: 132 mcg/dm², Meets ASTM D5712-10, Results generated values below 200 µg/dm² of aqueous extractable protein content. |
| Biocompatibility (ISO 10993-10:2010-08-01) | ||
| - Primary Skin Irritation | Not an irritant | Under the condition of the test, not an irritant. |
| - Dermal Sensitization | Not a sensitizer | Under the condition of the test, not a sensitizer. |
| Sterilization Validation (ISO 11137-1:2006) | Sterility Assurance Level (SAL) of 10-6 | Sterility Assurance Level (SAL) of 10-6 |
For Powder-free Latex Surgeon's Gloves:
| Characteristics | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimension (ASTM 3577-09e1) | ||
| Palm width | Size 6: 76±6 mm, 6 1/2: 83±6 mm, 7: 89±6 mm, 7 1/2: 95±6 mm, 8: 102±6 mm, 8 1/2: 108±6 mm, 9: 114±6 mm | Size 6: 76 |
| Overall Length | 265 mm min | Size 6: 268 |
| Finger Thickness | 0.10 mm min | 0.10~0.13 mm range across sizes (All reported values meet or exceed the minimum) |
| Palm Thickness | 0.10 mm min | 0.10~0.13 mm range across sizes (All reported values meet or exceed the minimum) |
| Cuff thickness | 0.10 mm min | 0.10~0.13 mm range across sizes (All reported values meet or exceed the minimum) |
| Physical Properties (ASTM 3577-09e1) | ||
| - Tensile Strength (Before Aging) | 24 MPa, min | 24.1-40.8 MPa (Reported values exceed the minimum) |
| - Ultimate Elongation (Before Aging) | 750% min | 961%-1239% (Reported values exceed the minimum) |
| - Stress at 500% Elongation | 5.5 MPa, max | 4.3~4.7 MPa (Reported values are below the maximum) |
| - Tensile Strength (After Aging) | 18 MPa, min (at 70±2 °C, 166±2 hrs) | 20.8-27.4 MPa (Reported values exceed the minimum) |
| - Ultimate Elongation (After Aging) | 560% min (at 70±2 °C, 166±2 hrs) | 761%-1103% (Reported values exceed the minimum) |
| Freedom from Holes (ASTM D5151-11) | Standard Acceptance Criteria: Holes at Inspection Level I, AQL 1.5 | Passed Standard Acceptance Criteria: Holes at Inspection Level I, AQL 1.5 |
| Powder residue (ASTM D6124-11) | ≤ 2 mg/glove | 0.6 mg/glove, Meets ASTM D6124-06 (Reapproved 2011), Results generated values below 2 mg of residual powder. |
| Protein Content (ASTM D5712-10) | ≤ 200 µg/dm² Aqueous extractable protein | Aqueous extractable protein: 61.6 mcg/dm², Meets ASTM D5712-10, Results generated values below 200 µg/dm² of Aqueous extractable protein content. |
| Biocompatibility (ISO 10993-10:2010-08-01) | ||
| - Primary Skin Irritation | Not an irritant | Under the condition of the test, not an irritant. |
| - Dermal Sensitization | Not a sensitizer | Under the condition of the test, not a sensitizer. |
| Sterilization Validation (ISO 11137-1:2006) | Sterility Assurance Level (SAL) of 10-6 | Sterility Assurance Level (SAL) of 10-6 |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the exact sample size for each test. For example, for "Palm width," it provides a range of measured values (e.g., 76~80 mm for size 6) rather than listing individual measurements or a specific count of gloves tested. However, the tests are stated to comply with referenced ASTM and ISO standards, which typically specify minimum sample sizes for such evaluations.
- Data Provenance: The testing was conducted by Anhui Anyu Latex Products Co., Ltd in China. It is a retrospective study since the data is collected and presented after the manufacturing and testing of the gloves.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document describes non-clinical, bench testing of physical and chemical properties of a medical device (surgical gloves). As such, "ground truth" is established by adherence to recognized international standards (ASTM and ISO). There are no human experts used to establish a clinical ground truth for this type of test.
4. Adjudication Method for the Test Set
Not applicable. The product performance is evaluated against objective, standardized criteria defined by ASTM and ISO specifications, not subjective human assessment requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This is a non-clinical bench test report for physical and chemical properties of gloves, not a clinical study involving human readers or cases.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This refers to a medical device, specifically surgical gloves, and not an algorithm or AI. Therefore, this question is not applicable. The performance described here is the inherent physical and chemical properties of the manufactured glove itself, which are measured using various testing methodologies.
7. The Type of Ground Truth Used
The "ground truth" for the test results is established by objective, quantitative measurements against the pre-defined specifications and acceptance criteria outlined in the referenced ASTM and ISO standards (e.g., ASTM D3577-09e1 for dimensions and physical properties, ASTM D5151-11 for freedom from holes, ASTM D6124-11 for powder amount, ASTM D5712-10 for protein content, ISO 10993-10 for biocompatibility, and ISO 11137-1:2006 for sterilization).
8. The Sample Size for the Training Set
Not applicable. This is a report on the testing of a manufactured medical device, not an AI/ML algorithm development. There is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set was Established
Not applicable. As explained above, this is not an AI/ML algorithm study.
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