(45 days)
Padded Mitts, Padded-Plus Mitts, Rigid Palm Padded Mitts, and Finger Separator Padded Mitts are intended for patients who remove bandages and dressings, pick and scratch at wounds, grasp and pull out feeding and naso-gastric tubes.
Rigid Palm Padded Mitts have a rigid insert and are intended for patients who require an additional barrier to prevent grasping.
Finger-Separator Padded Mitts have finger channels that help to control hand contracture.
Padded Mitts are constructed from woven polyester that encloses a 3/4-inch-thick foam palm pad. A top piece of polyester mesh is sewn on the mitts to prevent heat build-up. The mitts have a 1 1/4-inch-wide polyester wrist strap that secures by means of a metal buckle. The underside of the mitt cuff has a loop through which a 44-inch-long looped strap passes. This strap is used to secure the patient's hand/arm range of motion. The outer edges are finished with a bias cut binding. All straps are made of polyester webbing.
Padded-Plus Mitts are identical to the above except that the foam used for the palm pad is two-inches-thick.
Finger Separator Padded Mitts are identical to Padded-Plus Mitts except that the polyester mesh top piece is stitched to the polyester woven fabric in a such a way as to form finger channels.
Rigid-Palm Padded Mitts are identical to the Padded Mitts except that they have a pocket on the bottom side which contains a 6mm pvc insert. This rigid insert, which removes for laundering, is used for patients who require an additional barrier to prevent against grasping at feeding and naso-gastric tubes.
The provided text is a 510(k) Summary of Safety and Effectiveness for Padded Mitts and related products. It focuses on device descriptions, indications for use, and a comparison to previously marketed substantially equivalent devices. This document does not contain information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert evaluations as requested in the prompt.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the given input. The content is about the regulatory submission of a medical device, specifically protective restraints, and not about a performance study with detailed metrics.
§ 880.6760 Protective restraint.
(a)
Identification. A protective restraint is a device, including but not limited to a wristlet, anklet, vest, mitt, straight jacket, body/limb holder, or other type of strap, that is intended for medical purposes and that limits the patient's movements to the extent necessary for treatment, examination, or protection of the patient or others.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.