(118 days)
The Sterile Latex Examination Gloves Powder Free is a disposable device intended for medical purposes that is worn on the examiners' hand or finger to prevent contamination between patient and examiner.
The Sterile Latex Examination Gloves Powder Free are natural color, single use only, disposable examination gloves intended for medical purposes to be worn by examination between the patient and the examiner. The device is ambidextrous and can be worn on either the left or right hand. The gloves are offered in sizes small, medium, large and extra-large, and sterilized by Gamma radiation. The gloves are designed and manufactured in accordance with the ASTM D3578-19 standard.
The provided text describes the 510(k) summary for "Sterile Latex Examination Gloves Powder Free". This document focuses on demonstrating substantial equivalence to a predicate device based on non-clinical performance and biocompatibility testing, rather than an AI-driven medical device requiring extensive clinical validation of diagnostic accuracy. As such, many of the requested elements for AI/ML device studies (like sample sizes for test sets, expert ground truth adjudication, MRMC studies, training set details) are not applicable to the information provided.
However, I can extract the acceptance criteria and performance results for the non-clinical tests conducted for these gloves:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method / Item | Purpose | Acceptance Criteria | Reported Device Performance | Result |
|---|---|---|---|---|
| Dimensions (width) | Evaluate the physical dimension of the glove | Width: | Pass | |
| S: 80 ± 10 mm | S: 81mm min | |||
| M: 95 ± 10 mm | M: 95mm min | |||
| L: 105 ± 10 mm | L: 106mm min | |||
| XL: 115 ± 10 mm | XL: 115mm min | |||
| Dimensions (length) | Evaluate the physical dimension of the glove | Length: 230mm min | 238mm min length | Pass |
| Dimensions (thickness) | Evaluate the physical dimension of the glove | Palm – 0.08mm min. | ||
| Finger – 0.08mm min. | Palm – 0.11mm min. | |||
| Finger – 0.11mm min | Pass | |||
| Physical properties (Before aging) | Evaluate tensile strength and ultimate elongation before aging | Tensile Strength: 18 MPa, min. | ||
| Elongation: 650%, min. | ||||
| Stress at 500% Elongation: 5.5MPa, max. | Tensile Strength: 23.4MPa, min. | |||
| Elongation: 650%, min. | ||||
| Stress at 500% Elongation: 5.3MPa, max. | Pass | |||
| Physical properties (After aging) | Evaluate tensile strength and ultimate elongation after aging | Tensile Strength: 14 MPa, min. | ||
| Elongation: 500%, min. | Tensile Strength: 22MPa, min. | |||
| Elongation: 704%, min. | Pass | |||
| Freedom from holes | Detect holes in the gloves | No leakage at sampling level of G-1, AQL 1.5 | No leakage, 314 of 315 passed | Pass |
| Residual Powder | Detect powder residue in the glove |
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination 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). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.