(50 days)
MAXXUS Powder Free Orthopaedic Latex Surgical Gloves are Intended to protect the wearer from liquids such as body fluids and blood, as well as to protect surgical wounds or sterile fields from microbiological contamination from the wearer.
MAXXUS Powder Free Orthopaedic Latex Surgical Gloves meet the description of Rubber Surgical Gloves as described in American Society for Testing Materials (ASTM D 3577- 91) as Type 1 gloves compounded primarily from rubber latex. They are brown in color and are non-powdered. They are packaged sterile in pairs in sizes 5-1/2 through 9.
The provided text describes a medical device, MAXXUS* Powder Free Orthopaedic Latex Surgical Gloves, and its testing for regulatory approval. However, it does not include information about a study proving the device meets acceptance criteria in the context of an AI/ML medical device submission. The document is a 510(k) summary for a surgical glove, which is a very different type of medical device.
Therefore, I cannot fulfill the request to provide acceptance criteria and study details as it pertains to an AI/ML device. The information provided is about the physical and chemical properties of a physical medical device (gloves).
Here's why the provided text doesn't fit the request:
- Device Type: The device is "MAXXUS* Powder Free Orthopaedic Latex Surgical Gloves," a physical product, not an AI/ML algorithm.
- Tests Described: The tests mentioned are for physical properties (ASTM D-3577-91, 21 CFR 800.20, primary skin irritation, delayed contact sensitization, USP iodine test for starch). These are relevant for gloves, not for evaluating the performance of an AI model.
Therefore, all the specific points requested (sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth type, training set size, training set ground truth) are not applicable to the provided document.
{0}------------------------------------------------
SEP 2 0 1996
Summar
MAXXUS* POWDER FREE ORTHOPAEDIC LATEX SURGICAL GLOVES
Page 1 of 2
| Submitter's Name | Johnson & Johnson Medical Inc. |
|---|---|
| Submitter's Address: | 2500 Arbrook Blvd.Arlington, Texas 76014 |
| Submitter's Phone Number | (817) 784-4897 |
| Submitter's Fax Number: | (817) 784-5462 |
| Name of Contact Person: | Margaret Marsh |
| Date of Preparation: | September 17, 1996 |
| Name of Device: | |
| Trade Name: | MAXXUS* Powder Free Orthopaedic LatexSurgical Gloves |
| Common Name: | Surgical Gloves |
| Classification Name: | Surgeon's Gloves |
| Legally Marketed Device to WhichEquivalency is Being Claimed: | MAXXUS Powder Free Orthopaedic LatexSurgical Gloves as described in this 510(k)notification are substantially equivalent to thecurrently marketed MAXXUS OrthopaedicLatex Surgical Gloves. The manufacturingdifferences between the two products consist ofadditional steps needed to render the glovespowder free. |
| Description of the Device: | MAXXUS Powder Free Orthopaedic LatexSurgical Gloves meet the description of RubberSurgical Gloves as described in AmericanSociety for Testing Materials (ASTM D 3577-91) as Type 1 gloves compounded primarilyfrom rubber latex. They are brown in color andare non-powdered. They are packaged sterilein pairs in sizes 5-1/2 through 9. |
| Intended Use of the Device: | MAXXUS Powder Free Orthopaedic LatexSurgical Gloves are Intended to protect thewearer from liquids such as body fluids andblood, as well as to protect surgical wounds orsterile fields from microbiological contaminationfrom the wearer. |
| Summary of Technological CharacteristicsCompared to the Predicate Device: | The current notification describes minormodifications to the manufacturing processwhich allow for a powder free product. |
| Brief Discussion of Nonclinical Tests: | Testing performed per ASTM D-3577-91 and21 CFR 800.20 indicates that the productmeets the requirements of these standards. |
| Primary skin irritation testing in the rabbit anddelayed contact sensitization testing In theguinea pig indicate no irritation or sensitization. | |
| Final product is negative for the presence ofstarch using the USP iodine test. | |
| Brief Discussion of Clinical Tests: | No new clinical tests were conducted under this510(k). |
| Conclusions Drawn for the Nonclinical andClinical Tests: | Nonclinical laboratory and animal data indicatethat the powder free product meets allperformance and biocompatibilityrequirements. |
| Other Information Deemed Necessary byFDA | Not applicable |
{1}------------------------------------------------
5
MAXXUS* POWDER FREE ORTHOPAEDIC LATEX SURGICAL GLOVES Page 2 of 2
- Trademark
§ 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).