(77 days)
Not Found
No
The document describes a surgical glove and does not mention any AI or ML technology.
No
Explanation: The device is described as a surgical glove intended to provide a barrier against infectious material, which is a protective function, not a therapeutic one. It does not treat or cure a disease or condition.
No
Explanation: The device is described as a surgical glove intended to provide a barrier against infectious material and contaminants. Its function involves protection, not diagnosis. The "Indications for Use" section clearly states its purpose as a barrier. While it is an "indicator," this refers to its property as an underglove revealing a puncture in the outer glove, not an indicator of a medical condition.
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).
- Device Description: The description focuses on the material, sterility, and protein content of the glove. It does not describe any components or mechanisms for analyzing biological samples or providing diagnostic information.
- Lack of IVD Indicators: There is no mention of analyzing samples, detecting analytes, providing diagnostic results, or any other activities typically associated with IVD devices.
Therefore, the Biogel Eclipse Indicator Underglove is a medical device, specifically a surgical glove, but it does not fit the definition of an In Vitro Diagnostic device.
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 (comma separated list FDA assigned to the subject device)
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
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Characteristic Dimensions Meets ASTM D3577
Physical Properties Meets ASTM D3577
Freedom from Holes Pass
Biocompatibility Meets ASTM D3577 Standard
Primary Skin Irritation Pass
Guinea Pig Sensitization
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 - Regent Biogel Indicator Inner Surgical Glove, K053443 - Biogel Eclipse Surgical 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
Image /page/0/Picture/0 description: The image shows the logo for Molnlycke Healthcare. The logo consists of a cluster of small circles on the left side, followed by the text "MOLNLYCKE" in a sans-serif font. Below "MOLNLYCKE" is the word "HEALTHCARE" in a smaller, sans-serif font.
Image /page/0/Picture/1 description: The image shows the address of Molnlycke Heath Care US, LLC, located at 5550 Peachtree Parkway, Suite 500, Norcross, GA 30092. The image also contains the number K062847 at the top.
510(k) SUMMARY
DEC 2 0 2006 .
| 1. Applicant: | Mölnlycke Health Care US, LLC
5550 Peachtree Parkway Suite 500
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 Eclipse, Latex, Sterile, Powder Free, Indicator Underglove |
| Common Name: | Surgical Glove (CFR 878.4461) |
| Classification: | Class I |
| 4. Predicate Device : | K980942 - Regent Biogel Indicator Inner Surgical Glove
K053443 - Biogel Eclipse Surgical Glove |
| 5. Device Description: | The Biogel Eclipse Indicator Underglove is a sterile powder free, |
-
Intended Use of the Device:
-
Technological Characteristics of the Device:
The Biogel Eclipse Indicator Underglove characteristics are summarized below as compared to ASTM requirements and to the predicate devices.
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
polymer coated latex surgical glove. The glove contains 50 micrograms or less of total water extractable protein per gram.
Characteristic Dimensions Physical Properties Freedom from Holes Biocompatibility Primary Skin İrritation Guinea Pig Sensitization
Meets ASTM D3577 Meets ASTM D3577 Pass
Meets ASTM D3577
Standard
Pass
-
Performance Data
-
Clinical Data
-
- Conclusion:
The performance data are summarized above.
- Conclusion:
No clinical data was required.
material and other contaminants.
The Biogel Eclipse Indicator Underglove meets the technological characteristics of ASTM D3577 and is substantially equivalent to the predicate devices identified in sited in this 510(k) summary.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Steven Dowdley, RAC Director of Regulatory Affairs Mölnlycke Health Care US, LLC 5550 Peachtree Parkway, Suite 500 Norcross, Georgia 30092
DEC 2 0 2006
Re: K062847
Trade/Device Name: Biogel Eclipse, Latex, Sterile, Powder Free, Indicator Underglove Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: December 8, 2006 Received: December 11, 2006
Dear Mr. Dowdley:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
2
Page 2 - Mr. Dowdley
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Syette Y. Mchite Oms.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Image /page/3/Picture/0 description: The image shows the logo for Molnlycke Healthcare. The logo consists of a cluster of five circular shapes on the left, resembling a stylized flower or abstract design. To the right of the shapes, the text "MOLNLYCKE" is stacked above "HEALTHCARE" in a simple, sans-serif font. The overall design is clean and professional, suggesting a focus on health and well-being.
3.0 Indications for Use Statement:
INDICATION FOR USE
| Applicant: | Molnlycke Heath Care US, LLC |
|---|---|
| 510(k) Number: | K062847 |
| Device Name: | Biogel Eclipse, Latex, Sterile, Powder Free, Indicator Underglove |
Indication 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE)
Prescription Use Or Over-The-Counter Per 21 CFR 801.109
Shule H. Murphy MD
r of Anasthesiology, General Hospit on Control, Dental Devices
K 012847