(65 days)
None
Not Found
No
The document describes standard surgical gloves and their testing against established standards, with no mention of AI or ML technology.
No
The device, surgical gloves, is intended for protection during procedures, not for treating or diagnosing a medical condition.
No
The device, MICRO-TOUCH* Powder Free Latex Surgical Gloves, is intended to protect the wearer and surgical fields from contamination during hospital and surgical procedures. Its function is protective, not diagnostic.
No
The device is a physical product (surgical gloves) and does not involve any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to protect the wearer and the surgical field during surgical procedures. This is a barrier function, not a diagnostic function performed on samples taken from the body.
- Device Description: The description details the material and standards for surgical gloves, which are physical barriers.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
MICRO-TOUCH* Powder Free Latex Surgical Gloves are intended for single use in a variety of hospital and surgical procedures 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
MICRO-TOUCH Powder Free 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 white 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
hospital and surgical procedures
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
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. No new clinical tests were conducted under this 510(k).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical laboratory and animal data indicate that the powder free product meets all performance and biocompatability requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
JU. - 3 1996
510(k) Summary MICRO-TOUCH* POWDER FREE 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: | April 26, 1996 |
| Name of Device: | |
| Trade Name: | MICRO-TOUCH* Powder Free Latex Surgical |
| Gloves | |
| Common Name: | Surgical Gloves |
| Classification Name: | Surgeon's Gloves |
| Legally Marketed Device to Which | |
| Equivalency is Being Claimed: | MICRO-TOUCH Powder Free Latex Surgical |
| Gloves as described in this 510(k) notification | |
| are substantially equivalent to the currently | |
| marketed MICRO-TOUCH 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: | MICRO-TOUCH Powder Free 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 white in color and are non-powdered. | |
| They are packaged sterile in pairs in sizes 5- | |
| 1/2 through 9. | |
| Intended Use of the Device: | MICRO-TOUCH* Powder Free Latex Surgical |
| Gloves are intended for single use in a variety | |
| of hospital and surgical procedures 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 biocompatability | |
| requirements. | |
| Other Information Deemed Necessary by | |
| FDA: | Not applicable |
- Trademark
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