(180 days)
Powder Free NR Latex Surgical Glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
The subject device in this 510(k) Notification is Latex Surgeon's Glove Powder Free with Protein content labelling claims 50ug/dm2 or less per glove of extractable Protein. The subject device is a Surgeon's glove made from compounded primarily Natural Latex, Yellow, powder free and sterile (Per 21 CFR 878.4460, class I. The device meets all the specifications in ASTM 3577-09, Standard specification for Rubber Surgical Glove. Additionally, the gloves have been tested for biocompatibility. Latex Surgeon's Gloves Powder Free with Protein content labelling claims 50ug/dm² or less per glove of extractable Protein is classification as Type 1: Glove compounded primarily form Natural Rubber Latex The Proposed device is sterilized using Gamma irradiation method to achieve the sterility Assurance Level (SAL) of 10E and place in a sterility maintenance package to ensure a shelf life of 3 years Powder Free NR Latex Surgical Glove (Sterile), is a disposable device intended for medical purposes that is worn by operating room personal to protect a surgical wound from contamination (product Code KGO).
The provided text describes the regulatory review and approval of a medical device, specifically "Powder Free NR Latex Surgical Glove (Sterile) with Protein content labelling claims 50ug/dm2 or less per glove of extractable Protein." It details the device's characteristics, comparison to a predicate device, and the non-clinical testing performed to demonstrate substantial equivalence.
However, the request asks for information related to Acceptance Criteria and a Study that proves the device meets the acceptance criteria in the context of an AI/Machine Learning (ML) device. The provided document is a 510(k) premarket notification for a physical medical glove, not an AI/ML device.
Therefore, the document does not contain the information required to answer questions about acceptance criteria and studies for an AI/ML device. The concepts of "test set," "data provenance," "experts to establish ground truth," "adjudication method," "MRMC study," "standalone performance," "training set," and "ground truth for training set" are specific to the evaluation of AI/ML models, not physical medical devices like gloves.
The document discusses:
- Acceptance Criteria for the glove: These are defined by relevant ASTM standards (e.g., D3577-09 for dimensions, physical properties, freedom from pinholes; D6124-06 for powder residue; D5151-06 for pinhole level) and biocompatibility tests (ISO 10993-10).
- Study Proving Acceptance: Non-clinical testing was performed according to these standards, and the results ("PASS") demonstrate that the device meets these criteria.
- Performance Data: Tables on pages 4, 5, 7, and 8 show the specifications and test results for dimensions, physical properties (tensile strength, elongation before and after aging), freedom from pinholes, powder residue, protein content, biocompatibility (skin irritation, sensitization, systemic toxicity), sterility, and shelf life.
In summary, while the document provides acceptance criteria and performance data for a medical glove, it is not applicable to the specific questions regarding AI/ML device evaluation.
§ 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).