(64 days)
Not Found
No
The 510(k) summary describes a surgical glove and does not mention any AI or ML technology. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The device is a surgical glove intended for protection, not for treating a disease or condition.
No
The device is a surgical glove intended for protection during procedures, not for diagnosing medical conditions.
No
The device is a surgical glove, which is a physical product made of synthetic material, not software. The 510(k) summary describes physical properties and performance testing related to the material and construction of the glove.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "protection of operating room personnel and patients, from microbial migration and surgical wounds from contamination." This describes a barrier device used during procedures, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a surgical glove made of synthetic material. This aligns with a barrier device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information. The performance studies focus on physical properties, sterility, and freedom from holes, which are relevant to a surgical glove.
Therefore, the Biogel® Skinsense™ Sterile, Powder-Free, Synthetic Polyisoprene Surgical Glove is a medical device, but it falls under the category of a surgical glove, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Biogel® Skinsense™ Sterile, Powder-Free, Synthetic Polyisoprene Surgical Glove is a disposable device made of synthetic material and is intended for use in hospitals and other health care facilities during invasive or non-invasive procedures for the protection of operating room personnel and patients, from microbial migration and surgical wounds from contamination.
Product codes
KGO
Device Description
The device in this 510(k) submission is intended for the Biogel Skinsense™ Sterile, Powder-Free, Synthetic Polyisoprene Surgical Glove (Classification number 79KGO). The Biogel Skinsense™ Sterile, Powder-Free, Synthetic Polyisoprene Surgical Glove is a disposable device made from Non-Latex synthetic rubber material, polvisoprene. Glove size is available from size 5.5 through 9.0 in a half size increment.
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
hospitals and other health care facilities
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 gloves meet all ASTM D3577-00 requirements for sterility, freedom from holes, physical properties, and physical dimensions. The gloves have been tested and shown to be non-irritating and non-sensitizing under test conditions when evaluated in accordance with internationally recognized test methods. The gloves have been tested per ASTM D6124 and exceed the requirements to demonstrate "powder-free" in nature.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
k) New Device Submission – Pl Glove
PART VIII. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
In response to the requirements addressed by the Safe Medical Devices Act (SMDA) of 1990, a summary follows with the safety and effectiveness information upon which the substantial equivalence determination is based.
® Skinsense ™ Sterile, Powder-Free |
Synthetic Polyisoprene Surgeon's Glove### Indications for Use:
The Biogel Skinsense™ Sterile, Powder-Free, Synthetic Polyisoprene Surgical Glove is a disposable device made of synthetic material and is intended for use in hospitals and other health care facilities during invasive or non-invasive procedures for the protection of operating room personnel and patients, from microbial migration and surgical wounds from contamination.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
Over-The-Counter Use OI
Chin S. Cin
on Sign-Off) of Dental, Infection Control, Coneral Hospital Devices ter Blumber
9