(105 days)
Not Found
No
The device is a surgical glove and the description focuses on its material properties and performance as a barrier, with no mention of AI or ML.
No
The device is described as a surgical glove intended to provide a barrier against contaminants, not to treat or prevent a disease or condition.
No
Explanation: The device is a surgical glove, described as a barrier against infectious material. It is not used to diagnose a medical condition or disease.
No
The device is a physical glove made of natural rubber latex, not software. The description focuses on material properties and physical performance characteristics.
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 when worn on the hands in a surgical setting. This is a physical barrier function, not a diagnostic test performed on samples from the human body.
- Device Description: The description focuses on the physical properties and composition of the glove.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This surgical glove does not fit that description.
N/A
Intended Use / Indications for Use
The Biogel Orthopedic Surgeon's Glove 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 Orthodepic Surgical Glove 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.
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.
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.
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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
K041465
- 510(k) SUMMARY 1. Applicant: Mölnlycke Health Care US, LLC 5550 Peachtree Parkway Suite 500 SEP 1 1 2007 Norcross, GA 30092 2. Contact Person: Steven Dowdley, RAC Director of Regulatory Affairs Tel.: 678-250-7930 Fax: 678-250-7979 3. Device Name: Biogel Orthodeapic Surgical Glove with non-pyrogen statement Common Name: Classification: Surgical Glove (CFR 878.4461) Class I র্ব Predicate Device : K980516 - Biogel Orthodaepic Surgical Glove K060030 - Eclipse, Non-pyrogenic, Latex, Powder-free, Glove 5. Device Description: The Biogel Orthodepic Surgical Glove 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 Orthodaepic Surgical Glove 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 The Biogel Orthodaepic Surgical Glove characteristics are Device: summarized below as compared to ASTM requirements and to the predicate devices. Characteristic Standard Dimensions Meets ASTM D3577 Physical Properties Meets ASTM D3577 Freedom from Holes Meets ASTM D3577 Biocompatibility Meets ISO 10993-1 LALTest - final endotoxin