(123 days)
Not Found
Not Found
No
The document describes a surgical glove and does not mention any AI or ML technology.
No
Explanation: The device is a surgical glove intended to provide a barrier against contaminants, not to treat or prevent a disease or condition.
No
The device is described as a "barrier against potentially infectious material and other contaminants," which indicates a protective function, not a diagnostic one. It is a surgical glove.
No
The device description clearly states it is a physical glove made of polyisoprene, which is a hardware 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 provide a barrier against potentially infectious material and other contaminants by being worn on the hands. This is a physical barrier function, not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The description focuses on the material (polyisoprene), sterility, powder-free nature, and protein content of a surgical glove. These are characteristics of a medical device used for protection, not for diagnosing a condition.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information about a patient's health status.
- Performance Studies: The performance studies focus on physical properties, freedom from holes, and biocompatibility, which are relevant to the safety and effectiveness of a barrier device, not a diagnostic test.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Skinsense Polyisoprene Underglove is a disposable device made of non-natural rubber latex that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants.
Product codes (comma separated list FDA assigned to the subject device)
KGO
Device Description
The Skinsense Polyisoprene Underglove is a sterile powder free, polymer coated latex surgical glove. The glove contains 50 micrograms or less of total water extractable protein per gram.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgical setting
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance data are summarized above. No clinical data was required. The Skinsense Polyisoprene Underglove meets the technological characteristics of ASTM D3577-01-ae2 and is substantially equivalent to the predicate devices identified in sited in this 510(k) summary.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image shows a logo for "MIDLANDCARE HEALTHCARE". On the left side of the logo, there is a graphic of several circles clustered together. The text is stacked on the right side of the logo.
Molnlycke Heath Care US, LLC 5550 Peachtree Parkway, Suite 500 Norcross, GA. 30092
Koyllso
IG 2 6 200
510(k) SUMMARY
-
- Applicant:
-
- Contact Person:
-
- Device Name: Common Name: Classification:
-
- Predicate Device : Device Description:
-
- Intended Use of the Device:
- Technological Characteristics of the Device:
Characteristic Dimensions Physical Properties Freedom from Holes Biocompatibility Cytotoxiciity Study ISO Skin Irritation Study LAL Test
- Performance Data
-
- Clinical Data
-
- Conclusion:
Mölnlycke Health Care US, LLC 5550 Peachtree Parkway Suite 500 Norcross, GA 30092
Steven Dowdley, RAC Director of Regulatory Affairs Tel.: 678-250-7930 678-250-7979 Fax:
Skinsense Polyisoprene Underglove Surgical Glove (CFR 878.4461) Class I
The Skinsense Polyisoprene Underglove is a sterile powder free, polymer coated latex surgical glove. The glove contains 50 micrograms or less of total water extractable protein per gram.
The Skinsense Polyisoprene Underglove is a disposable device made of natural rubber latex that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants.
The Skinsense Polyisoprene Underglove characteristics are summarized below as compared to ASTM requirements and to the predicate devices.
Standard Meets ASTM D3577 Meets ASTM D3577 Meets ASTM D3577
Pass Pass