(95 days)
Not Found
No
The summary describes a surgical glove and does not mention any AI or ML components or functionalities.
No
The device is a surgical glove intended to provide a barrier against infectious material, not to treat or cure a medical condition.
No
The device is described as a surgical glove intended to provide a barrier against contaminants. It does not mention any diagnostic capabilities, such as detecting, identifying, or monitoring diseases or conditions.
No
The device is a physical glove made of natural 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 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 specimens like blood, urine, or tissue.
- Device Description: The description focuses on the material and properties of a surgical glove. It doesn't mention any components or functions related to analyzing biological samples or providing diagnostic information.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting biomarkers, or providing any kind of diagnostic result.
IVD devices are specifically designed to perform tests on specimens from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This glove does not fit that description.
N/A
Intended Use / Indications for Use
The Biogel® Indicator™ 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.
Product codes (comma separated list FDA assigned to the subject device)
KGO
Device Description
The Biogel® Indicator™ 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
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance data are summarized above. No clinical data was required.
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.
K980942 - Biogel® Indicator™ Underglove, K060030 - Eclipse, Non-pyrogenic, Latex, Powder-free, Glove
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
| 1. | 510(k) SUMMARY
Applicant: | SEP 10 2007
Mölnlycke Health Care US, LLC
5550 Peachtree Parkway Suite 500
Norcross, GA 30092 |
|-----|---------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. | Contact Person: | Steven Dowdley, RAC
Director of Regulatory Affairs, Molnlycke Health Care, US LLC
Tel.: 678-250-7930
Fax: 678-250-7979 |
| | | or |
| | | Marcia K. Ash, RAC
MKA Consulting
Tel: 404-906-0492 |
| 3. | Device Name: | Biogel® Indicator™ Underglove with non-pyrogen statement |
| | Common Name:
Classification: | Surgical Glove (CFR 878.4461)
Class I |
| 4. | Predicate Device : | K980942 - Biogel® Indicator™ Underglove |
| | | K060030 - Eclipse, Non-pyrogenic, Latex, Powder-free, Glove |
| 5. | Device Description: | The Biogel® Indicator™ 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. |
| 6. | Intended Use of the Device: | The Biogel® Indicator™ 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. |
| 7. | Technological Characteristics of the
Device: | The Biogel® Indicator™ Underglove characteristics are
summarized below as compared to ASTM requirements and to
the predicate devices. |
| | Characteristic
Dimensions
Physical Properties
Freedom from Holes
Biocompatibility
LALTest - final endotoxin
concentration | Standard
Meets ASTM D3577
Meets ASTM D3577
Meets ASTM D3577
Meets ISO 10993-1