(112 days)
No
The 510(k) summary describes a surgical glove and explicitly states "Not Found" for mentions of AI, DNN, or ML, and does not describe any features or functionalities that would typically involve AI/ML.
No.
The device is a surgical glove intended as a barrier, not to treat or diagnose a disease or condition.
No
This device is a surgical glove intended as a barrier, not for diagnosing medical conditions.
No
The device description clearly states it is a "disposable device made of natural rubber latex" and a "sterile powder free, polymer coated latex surgical glove," indicating it is a physical hardware device, 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 biological samples.
- Device Description: The description focuses on the material and characteristics of a surgical glove.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.
N/A
Intended Use / Indications for Use
The Biogel Eclipse 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
KGO
Device Description
The Biogel Eclipse 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
usually in a 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
The performance data are summarized above. No clinical data was required.
Key Metrics
Characteristic Dimensions: Meets ASTM D3577
Physical Properties: Meets ASTM D3577
Freedom from Holes: Meets ASTM D3577
Biocompatibility: Pass
Primary Skin Irritation: Pass
Guinea Pig Sensitization: Pass
LALTest-(final endotoxin concentration):
§ 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
510(k) SUMMARY
- Applicant: 1.
-
- 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 Primary Skin Irritation Guinea Pig Sensitization LALTest-(final endotoxin concentration)
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- Performance Data
- ு. Clinical Data
-
- Conclusion:
Mölnlycke Health Care US, LLC 5550 Peachtree Parkway Suite 500 Norcross, GA 30092
SEP 1 0 2007
Steven Dowdley, RAC Director of Regulatory Affairs Tel.: 678-250-7930 Fax: 678-250-7979
Biogel Eclipse Indicator Underglove with non-pyrogen statement
Surgical Glove (CFR 878.4461) Class |
K062847 - Biogel Eclipse Latex, Sterile, Powder Free, Indicator Underglove
The Biogel Eclipse 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.
The Biogel Eclipse 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.
The Biogel Eclipse Indicator 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