(406 days)
The Sterile Powder Free Synthetic Rubber Gloves is a single use disposable device intended to be worn by operating room personnel to protect a surgical wound from contamination.
Sempermed Syntegra IR is a sterile powder-free surgeon glove. It is a disposable device made of synthetic polyisoprene rubber inside coated with synthetic material to ease donning the glove. This glove is intended to be worn on hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
The document describes the acceptance criteria and performance of the "Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves." The device is a surgical glove, and its performance is evaluated against ASTM standards and ISO standards for biocompatibility.
Here's a breakdown of your requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Standard / Acceptance Criteria | Reported Device Performance (Sempermed Syntegra IR) |
|---|---|---|
| Dimensions | ASTM 3577-09 | Meets standard requirements |
| Physical Properties | ASTM 3577-09 | Meets standard requirements |
| Thickness | ASTM 3577-09 | Meets standard requirements |
| Tear Strength (min 0.10mm) | $\leq$ 0.10 mm | Min 0.10 mm |
| Physical Properties Before Aging: | ASTM D3577 | Meets |
| - Tensile Strength | $\geq$ 17 MPa | 17 MPa min |
| - Ultimate Elongation | 650 % min | 650% min |
| - Stress at 500% Elongation | $\leq$ 7.0 MPa | 7.0 MPa |
| Physical Properties After Aging: | ASTM D3577 | Meets |
| - Tensile Strength | $\geq$ 12 MPa | 12 MPa min |
| - Ultimate Elongation | 490 % min | 490 % min |
| Powder Free | ASTM D6124-06: Requirements of $\leq$ 2 mg/glove for Powder-Free designation per ASTM D3577 | Meets; Requirements of $\leq$ 2 mg/glove for Powder-Free designation per ASTM D3577 |
| Sterile | - | Sterile |
| Biocompatibility: | ||
| - Primary Skin Irritation | ISO 10993-10:2002/Amd 1:2006(E) Biological evaluation of medical devices – Part 10: Tests for irritation and delayed-type hypersensitivity – Amendment 1:2006-07-15 | Pass; Under the conditions of the studies, the device is non-irritating |
| - Dermal Sensitization | ISO 10993-10:2002/Amd 1:2006(E) Biological evaluation of medical devices – Part 10: Tests for irritation and delayed-type hypersensitivity – Amendment 1:2006-07-15 | Pass; Under the conditions of the studies, the device is a non-sensitizer |
| Watertight | ASTM D 5151: Passes ASTM D3577 when tested in accordance with ASTM 5151 Inspection Level 1, AQL 1.5 | Pass; Passes ASTM D3577 when tested in accordance with ASTM 5151 Inspection Level 1, AQL 1.5 |
| Intended Use | A surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. | The Sterile Powder Free Synthetic Rubber Gloves is a single use disposable device intended to be worn by operating room personnel to protect a surgical wound from contamination. |
| Material | - | Synthetic Rubber |
| Innercoating | - | Synthetic |
| Color | - | Crème (Similar to Predicate's Natural White) |
| Texture | - | Textured (Micro-rough) |
| Size | - | 5½, 6, 6½, 7, 7½, 8, 8½, and 9 |
Detailed Study Information:
The provided document is a 510(k) Premarket Notification summary for a medical device (surgical gloves). It focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than a clinical study proving device effectiveness in a diagnostic or treatment context. Therefore, many of the questions regarding clinical study design (sample size for test/training sets, experts, MRMC, etc.) are not applicable to this type of submission.
Here's what can be inferred from the document:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable in the traditional sense of a diagnostic/AI test set. The "test set" here refers to samples of the manufactured gloves used for physical and biocompatibility testing. The document does not specify the sample sizes for these tests, but they would be governed by the respective ASTM and ISO standard methodologies (e.g., AQL for watertight testing).
- Data Provenance: Not specified, but the manufacturing company is Semperit Investment Asia Pte. Ltd. (Singapore), and the standards applied are international (ASTM, ISO). The tests would likely be conducted by the manufacturer or a certified testing laboratory.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. For physical and biocompatibility testing of surgical gloves, "ground truth" is established by adherence to standardized measurement and analytical protocols defined by ASTM and ISO organizations, not by expert consensus in the diagnostic sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are typically for subjective assessments or when there's disagreement among human readers/experts. These tests involve objective measurements and chemical/biological assays.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This is a physical device (surgical glove), not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical device (surgical glove), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the performance claims about the surgical glove is established by adherence to objective, standardized measurements and biological assays as defined by the referenced ASTM and ISO standards (e.g., tensile strength, elongation, powder content, skin irritation, sensitization, watertightness).
8. The sample size for the training set
- Not Applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. As above, no training set for an AI model.
In summary: The document demonstrates that the "Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves" meets established performance standards for surgical gloves, primarily by demonstrating its physical characteristics and biocompatibility conform to ASTM and ISO specifications. The evaluation is focused on non-clinical performance data to show substantial equivalence to a legally marketed predicate device, rather than a clinical comparative study or an AI algorithm validation.
§ 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).