(50 days)
The provided text does not contain any predicate devices. The section "Predicate Device(s)" explicitly states "Not Found".
None
No
The device description and performance studies focus on the physical properties and testing of surgical gloves, with no mention of AI or ML.
No.
The gloves are intended to protect the wearer and the surgical field from contamination, not to treat a disease or condition. They are a barrier device.
No
The device, MAXXUS Powder Free Orthopaedic Latex Surgical Gloves, is intended to protect the wearer and the surgical field from contamination, and is described as a surgical glove. It does not perform any diagnostic function.
No
The device description clearly states it is a physical product (surgical gloves) made from rubber latex, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the gloves are for protecting the wearer from liquids and protecting surgical wounds/sterile fields from contamination. This is a barrier function, not a diagnostic function.
- Device Description: The description focuses on the material (latex), standards met (ASTM D 3577-91), and physical characteristics (color, powder-free, sterile packaging). There is no mention of any components or functions related to testing or analyzing samples from the human body.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device is a surgical glove, which is a medical device used for protection and maintaining sterility during surgical procedures. It does not perform any in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
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.
Product codes
Not Found
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Nonclinical laboratory and animal data indicate that the powder free product meets all performance and biocompatibility requirements.
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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 Latex |
| Surgical Gloves | |
| Common Name: | Surgical Gloves |
| Classification Name: | Surgeon's Gloves |
| Legally Marketed Device to Which | |
| Equivalency is Being Claimed: | MAXXUS Powder Free Orthopaedic Latex |
| Surgical Gloves as described in this 510(k) | |
| notification are substantially equivalent to the | |
| currently marketed MAXXUS Orthopaedic | |
| Latex Surgical Gloves. The manufacturing | |
| differences between the two products consist of | |
| additional steps needed to render the gloves | |
| powder free. | |
| Description of the Device: | 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- |
- 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. |
| Intended Use of the Device: | 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. |
| Summary of Technological Characteristics
Compared to the Predicate Device: | The current notification describes minor
modifications to the manufacturing process
which allow for a powder free product. |
| Brief Discussion of Nonclinical Tests: | Testing performed per ASTM D-3577-91 and
21 CFR 800.20 indicates that the product
meets the requirements of these standards. |
| | Primary skin irritation testing in the rabbit and
delayed contact sensitization testing In the
guinea pig indicate no irritation or sensitization. |
| | Final product is negative for the presence of
starch using the USP iodine test. |
| Brief Discussion of Clinical Tests: | No new clinical tests were conducted under this
510(k). |
| Conclusions Drawn for the Nonclinical and
Clinical Tests: | Nonclinical laboratory and animal data indicate
that the powder free product meets all
performance and biocompatibility
requirements. |
| Other Information Deemed Necessary by
FDA | Not applicable |
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MAXXUS* POWDER FREE ORTHOPAEDIC LATEX SURGICAL GLOVES Page 2 of 2
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