(66 days)
The Medispo Rubber/Polyisoprene surgical gloves are sterile and single use device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination.
The proposed devices, surgical gloves, are sterile and disposable devices. There are two types of surgical gloves according to the raw materials in this submission:
- Type 1-Natural rubber surgical gloves .
- Type 2-Synthetic polyisoprene surgical gloves .
The proposed devices are powder-free gloves with creamy white in color. There are seven sizes (6", 6.5", 7", 7.5", 8", 8.5", 9") available for the gloves whichever are smooth- or texture-surfaced, with or without a rolled rim at the cuff edge.
The gloves are sterilized by ionizing irradiation. The shelf-life is three (3) years.
This document is a 510(k) premarket notification for Medispo Rubber Surgical Gloves and Medispo Polyisoprene Surgical Gloves. It compares the proposed devices to legally marketed predicate devices to demonstrate substantial equivalence.
Here's a breakdown of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Item | Acceptance Criteria (Methodology / Standard) | Reported Device Performance |
|---|---|---|
| Medispo Rubber Surgical Gloves (Main Material: Natural Rubber) | ||
| Product Code | KGO | KGO |
| Regulation No. | 21 CFR 878.4460 | 21 CFR 878.4460 |
| Classification | Class I | Class I |
| Gloves classification | Type I, Surgeon's gloves | Type I, Surgeon's gloves |
| Powder free | Yes | Yes |
| Indication for use | To protect a surgical wound from contamination | To protect a surgical wound from contamination |
| Palm width | 76mm±5mm (6.0), 83mm±5mm (6.5), 89mm±5mm (7.0), 95mm±5mm (7.5), 102mm±6mm (8.0), 108mm±6mm (8.5), 114mm±6mm (9) (ASTM D3767-03(2020)) | Pass |
| Length | 265mm min (6.0, 6.5), 270mm min (7.0, 7.5, 8.0), 280mm min (8.5, 9) (ASTM D3767-03(2020)) | Pass |
| Thickness | Cuff: min 0.10mm, Palm: min 0.13mm, Finger tip: min 0.13mm (ASTM D3767-03(2020)) | Pass |
| Freedom from holes | AQL 1.5 (ASTM D5151-19) | Pass |
| Physical Properties (before aging) | Tensile Strength: ≥24 MPa, Ultimate Elongation: ≥750% (ASTM D412-16) | Pass |
| Physical Properties (after aging) | Tensile Strength: ≥18 MPa, Ultimate Elongation: ≥560% (ASTM D412-16) | Pass |
| Powder residual | ≤2.0 mg/glove (ASTM D6124-06(2017)) | Pass |
| Special label claim | No protein labeling statement | No protein labeling statement |
| Sterility | Sterile | Sterile |
| Sterilization method | Radiation | Radiation |
| For single use | Yes | Yes |
| Type of use | Over the counter use | Over the counter use |
| Biocompatibility | Conform to ISO 10993 series standards | Conform to ISO 10993 series standards |
| Medispo Polyisoprene Surgical Gloves (Main Material: Synthetic Polyisoprene) | ||
| Product Code | KGO | KGO |
| Regulation No. | 21 CFR 878.4460 | 21 CFR 878.4460 |
| Classification | Class I | Class I |
| Gloves classification | Type II, Surgeon's gloves | Type II, Surgeon's gloves |
| Powder free | Yes | Yes |
| Indication for use | To protect a surgical wound from contamination | To protect a surgical wound from contamination |
| Palm width | 76mm±5mm (6.0), 83mm±5mm (6.5), 89mm±5mm (7.0), 95mm±5mm (7.5), 102mm±6mm (8.0), 108mm±6mm (8.5), 114mm±6mm (9) (ASTM D3767-03(2020)) | Pass |
| Length | 265mm min (6.0, 6.5), 270mm min (7.0, 7.5, 8.0), 280mm min (8.5, 9) (ASTM D3767-03(2020)) | Pass |
| Thickness | Cuff: min 0.10mm, Palm: min 0.13mm, Finger tip: min 0.13mm (ASTM D3767-03(2020)) | Pass |
| Freedom from holes | AQL 1.5 (ASTM D5151-19) | Pass |
| Physical Properties (before aging) | Tensile Strength: ≥24 MPa, Ultimate Elongation: ≥750% (ASTM D412-16) | Pass |
| Physical Properties (after aging) | Tensile Strength: ≥18 MPa, Ultimate Elongation: ≥560% (ASTM D412-16) | Pass |
| Powder residual | ≤2.0 mg/glove (ASTM D6124-06(2017)) | Pass |
| Sterility | Sterile | Sterile |
| Sterilization method | Radiation | Radiation |
| For single use | Yes | Yes |
| Type of use | Over the counter use | Over the counter use |
| Biocompatibility | Conform to ISO 10993 series standards | Conform to ISO 10993 series standards |
Study that Proves the Device Meets Acceptance Criteria:
The document states: "The performance test of the subject devices were performed on the final finished device. The test results show the subject devices meet the requirements of ASTM D3577-19."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample size used for each specific test or the data provenance (country of origin, retrospective/prospective). It only mentions that "performance tests...were performed on the final finished device" according to relevant ASTM and ISO standards.
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)
This information is not applicable as the device is a surgical glove, and the evaluation is based on mechanical, physical, and chemical properties, as well as biocompatibility, against established standards. There is no "ground truth" requiring expert consensus in the context of medical image analysis or similar diagnostic applications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the type of device and testing performed. Adjudication methods are typically relevant for subjective evaluations or interpretations, which are not present here.
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
This information is not applicable as the device is a surgical glove and does not involve human readers or AI assistance in its function.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance evaluation of the surgical gloves is based on established industry and regulatory standards such as ASTM D3577-19, ASTM D3767-03(2020), ASTM D5151-19, ASTM D6124-06(2017), ASTM D412-16, relevant USP standards, and ISO 10993 series standards for biocompatibility. These standards define the acceptable physical, mechanical, and biological properties of the gloves.
8. The sample size for the training set
This information is not applicable as the device is a physical product (surgical gloves) and does not involve machine learning models that require training sets.
9. How the ground truth for the training set was established
This information is not applicable as the device is a physical product and does not involve machine learning models that require training sets or their associated ground truth.
§ 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).