(48 days)
The Pure Advantage Powder Free Nitrile Surgical Glove, Hypoallergenic is "a disposable device intended for medical purposes that is worn by operating room personnel to protect a surgical wound from contamination" (21CFR 878.4460).
Nitrile rubber films form an excellent barrier to body fluids and bloodborne pathogens. The nitrile rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing fine movements necessary for medical treatment. The absence of natural rubber latex in the product yields no latex protein allergens. Nitrile rubber is known to create a superior barrior to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. No latex protein allergens and a minimum of curative agents Impart hypoallergenic properties to the glove. The leaching process romoves traces of accelerants that may be chemically Irrifating. The Powder wash process for powdered gloves is replaced by a chiorine process. The chiorination process eliminates the surface drag of the nitrile rubber, thereby ellminating the need for donning powder.
The provided text describes a 510(k) submission for a surgical glove and does not contain information about an AI/ML medical device. Therefore, I cannot extract the acceptance criteria, study details, and other requested information pertaining to an AI/ML device.
The document discusses:
- Device Name: Pure Advantage Powder Free Nitrile Hypoallergenic Surgical Glove
- Submitter: Tillotson Healthcare Corporation
- Submission Date: May 29, 1997
- Predicate Device: Pure Advantage Powder Free Nitrile Surgical Glove K922116
- Intended Use: Disposable device, intended for medical purposes, worn by operating room personnel to protect a surgical wound from contamination. Hypoallergenic suitable for low sensitizing situations, powder-free for situations where powder is not desirable.
- Performance Standards (Non-Clinical): ASTM standards for water tightness.
- Clinical Tests (Safety): Rabbit Irritation (Passes), Guinea Pig Maximization (Passes), Modified Draize Repeat Insult Patch Test - 200 Human Subjects (Passes).
- FDA Acknowledgment: Letter from FDA stating substantial equivalence to predicate device.
Key takeaway: This is a submission for a physical medical device (surgical glove), not an AI/ML-driven diagnostic or therapeutic device. As such, the specific questions regarding AI/ML device performance, sample sizes for AI models, ground truth establishment, expert adjudication, and MRMC studies are not applicable to the provided content.
§ 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).