(99 days)
The Ultra Preserve With Aloe Vera (Green) Examination Glove is "a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.". (21CFR 880.6250).
Natural Rubber Latex films form a barrier to body fluids and bloodborne pathogens. The latex rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. Natural Rubber Latex is known to create a barrier to bloodborne pathogens and and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The leaching process removes traces of chemical accelerants that may be chemically irritating. The glove is manufactured in accordance with the requirements of ASTM D3578-00 and ASTM D5151-99 requirements.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Ultra Preserve With Aloe Vera (Green) Natural Rubber Latex Examination Glove:
Summary on Acceptance Criteria and Supporting Studies
This 510(k) submission primarily relies on performance testing against established ASTM standards and comparison to legally marketed predicate devices to demonstrate substantial equivalence. It does not involve a study with human readers or AI, as it is for a medical device (examination glove) where performance is evaluated through material properties and barrier integrity rather than diagnostic interpretation.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Standard/Characteristic | Acceptance Criteria (Predicate) | Reported Device Performance (Proposed) |
|---|---|---|
| Water Tightness | ASTM D5151-99 | ASTM D5151-99 (Meets or Exceeds) |
| Residual Protein | ASTM D5712-99 | ASTM D5712-99 (Meets or Exceeds) |
| Residual Particulate | ASTM D6124-00 | ASTM D6124-00 (Meets or Exceeds) |
| Antigenic Protein | ASTM D6499-00 | ASTM D6499-00 (Meets or Exceeds) |
| Rabbit Irritation | Pass | Pass (Meets or Exceeds) |
| Guinea Pig Sensitization | Pass | Pass (Meets or Exceeds) |
| Protein Content Claim |
§ 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.