(55 days)
The Sensi Grip® Surgical Glove is a disposable device intended for medical use within hospitals and other healthcare facilities during invasive and non-invasive medical procedures requiring sterility. They are intended to be worn on the operating room personnel's hand to protect a surgical wound from contamination.
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 and washing process removes traces of chemical accelerants That may be chemically irritating. The glove is manufactured in accordance with the Requirements of ASTM D3577-00 and ASTM D5151-99 requirements.
{
"1. A table of acceptance criteria and the reported device performance": {
"Non-Clinical Tests": {
"SPECIFICATION": [
"PERFORMANCE STANDARDS",
"WATER TIGHTNESS",
"RESIDUAL PROTEIN"
],
"ACCEPTANCE CRITERIA (Proposed Powdered Glove)": [
"ASTM D3577-00: Meets or Exceeds Requirements",
"ASTM D5151-99: Meets or Exceeds Requirements",
"ASTM D5712-99: Meets or Exceeds Requirements"
],
"REPORTED DEVICE PERFORMANCE (Proposed Powdered Glove)": [
"Meets or Exceeds Requirements",
"Meets or Exceeds Requirements",
"Meets or Exceeds Requirements"
],
"PREDICATE DEVICE PERFORMANCE": [
"ASTM D3577-91: Meets or Exceeds Requirements",
"ASTM D5151-92: Meets or Exceeds Requirements",
"Not applicable (predicate did not have a protein labeling claim)"
]
},
"Clinical Tests": {
"SPECIFICATION": [
"SAFETY: SKIN IRRITATION",
"SKIN SENSITIZATION"
],
"ACCEPTANCE CRITERIA (Proposed Powdered Glove)": [
"Meets or Exceeds Requirements",
"Meets or Exceeds Requirements"
],
"REPORTED DEVICE PERFORMANCE (Proposed Powdered Glove)": [
"Meets or Exceeds Requirements",
"Meets or Exceeds Requirements"
],
"PREDICATE DEVICE PERFORMANCE": [
"Meets or Exceeds Requirements",
"Meets or Exceeds Requirements"
]
}
},
"2. Sample sized used for the test set and the data provenance": "The document does not explicitly state the sample sizes used for the non-clinical and clinical tests. It only refers to meeting or exceeding ASTM standards and general safety requirements. The data provenance is implied to be from tests conducted by the manufacturer, Tillotson Healthcare Corporation, in the USA.",
"3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts": "Not applicable. This is a medical device submission for surgical gloves, not a diagnostic device requiring expert interpretation of results to establish ground truth.",
"4. Adjudication method for the test set": "Not applicable. This is a medical device submission for surgical gloves, not a diagnostic device requiring adjudication of results.",
"5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance": "Not applicable. This is a medical device submission for surgical gloves, not an AI-assisted diagnostic tool.",
"6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": "Not applicable. This is a medical device submission for surgical gloves, not an AI algorithm.",
"7. The type of ground truth used": "For non-clinical tests (Performance Standards, Water Tightness, Residual Protein), the 'ground truth' is defined by adherence to established ASTM standards (D3577-00, D5151-99, D5712-99). For clinical tests (Skin Irritation, Skin Sensitization), the 'ground truth' is implied to be established through standard safety evaluations demonstrating the glove meets or exceeds safety requirements.",
"8. The sample size for the training set": "Not applicable. This is a medical device submission for surgical gloves, not a machine learning model requiring a training set.",
"9. How the ground truth for the training set was established": "Not applicable. This is a medical device submission for surgical gloves, not a machine learning model."
}
§ 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).