(608 days)
MOTEX Polyisoprene Powder-Free Sterile Surgical Gloves are powder-free surgeon's glove made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. The lubricating or dusting powder used in the glove is excluded.
Motex Powder-free Polyisoprene Surgical Sterile Gloves, Model # 6412 Nature, 6412_Blue; 6512_Nature, 6512_Blue are made of synthetic rubber. The sterile gloves are sterilized by the radiation method. 6412 Nature, 6412 Blue are of thin gloves. 6512 Nature, 6512 Blue are of thick gloves. They are processed by special treatment with no protein, and intended to be used in surgery to prevent the cross contamination between patients and users.
The provided text describes the acceptance criteria and the study results for the MOTEX Polyisoprene Powder-free Sterile Surgical Gloves. It is a 510(k) submission, demonstrating substantial equivalence to a predicate device, rather than a study proving the device meets acceptance criteria in the context of an AI/ML medical device. However, I can reframe the information to fit the requested table and provide a "study" description based on the non-clinical tests performed to show substantial equivalence.
Here's the breakdown of the information as requested, adapted for this type of medical device submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Standard Reference) | Reported Device Performance |
|---|---|---|
| Dimensions | Meets ASTM D 3577-09 | Meets ASTM D 3577-09 |
| Length | Not specified in standard, but within product spec | $280 \pm 6$ mm |
| Width (various sizes) | Not specified in standard, but within product spec | size 6–77mm, 6.5–84mm, 7–91mm, 7.5–98mm, 8–102mm, 8.5–108mm |
| Thickness (finger, palm) | Not specified in standard, but within product spec | Model 6412: $0.13 \pm 0.03$ mm; Model 6512: $0.15 \pm 0.03$ mm |
| Physical Properties | Meets ASTM D 3577-09 | Meets ASTM D 3577-09 |
| Tensile Strength (Before Aging) | Not specified in standard, but within product spec | 24 Mpa |
| Tensile Strength (After Aging) | Not specified in standard, but within product spec | 23 Mpa |
| Ultimate Elongation (Before Aging) | Not specified in standard, but within product spec | 929% |
| Ultimate Elongation (After Aging) | Not specified in standard, but within product spec | 879% |
| Freedom from Holes | Meets ASTM D 3577-09 | Meets ASTM D 3577-09 |
| Water Leak Testing | Meets ASTM D 5151-06 (Reapproved 2011), AQL=1.5 | Meets ASTM D 5151-06 (Reapproved 2011), AQL=1.5 |
| Residual Powder Testing | Meets ASTM D 6124-06 (Reaffirmation 2011), |
§ 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).