(77 days)
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 is a sterile powder free, polymer coated latex surgical glove. The glove contains 50 micrograms or less of total water extractable protein per gram.
This document describes a 510(k) premarket notification for the Biogel Eclipse, Latex, Sterile, Powder Free, Indicator Underglove. As such, the focus is on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical study data for new product claim validation.
Here's a breakdown of the requested information based on the provided text, along with an explanation of why some points are not applicable in this context:
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Acceptance Criteria (from ASTM D3577) | Reported Device Performance |
|---|---|---|
| Dimensions | Meets ASTM D3577 | Pass |
| Physical Properties | Meets ASTM D3577 | Pass |
| Freedom from Holes | Meets ASTM D3577 | Pass |
| Biocompatibility (Primary Skin Irritation) | Standard | Pass |
| Biocompatibility (Guinea Pig Sensitization) | Standard | Pass |
| Total Water Extractable Protein | 50 micrograms or less per gram | Less than 50 micrograms per gram |
Explanation: The document explicitly states "The Biogel Eclipse Indicator Underglove meets the technological characteristics of ASTM D3577." The "Pass" indicates compliance with these criteria. The protein content is a specific characteristic mentioned with its own pass/fail threshold.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated in the provided text. The document refers to meeting ASTM D3577, which would define the sample sizes for the various tests.
- Data Provenance: Not explicitly stated, but typically, these tests are conducted by the manufacturer or accredited testing laboratories. The data would be specific to lots of the manufactured device. These are likely prospective tests performed on newly manufactured devices to ensure they meet the standard.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not Applicable in this context. The "ground truth" for evaluating surgical glove performance is defined by established international standards like ASTM D3577 and biocompatibility testing protocols, not by expert consensus on individual cases. These standards specify objective physical and chemical tests.
4. Adjudication Method for the Test Set:
- Not Applicable in this context. Since the "ground truth" is based on objective physical and chemical test results against a standard, there is no need for expert adjudication. The test results are either within the specified limits or not.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
- Not Applicable. This device is a surgical glove, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study and the concept of "human readers" or "AI assistance" do not apply.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Not Applicable. This is a physical medical device (surgical glove), not an algorithm or software. "Standalone performance" in the context of AI algorithms does not apply here.
7. The Type of Ground Truth Used:
- Objective Test Standards and Specifications: The ground truth for this device is based on
- ASTM D3577: A standard specification for rubber surgical gloves, which defines acceptable levels for dimensions, physical properties (e.g., tensile strength, elongation), and freedom from holes.
- Biocompatibility Standards: Specific standards for primary skin irritation and guinea pig sensitization, which define acceptable reactions (or lack thereof) to ensure the device is not harmful to tissue.
- Chemical Analysis: Measurement of total water extractable protein content against a specified limit (50 micrograms or less per gram).
8. The Sample Size for the Training Set:
- Not Applicable. This is a physical medical device and does not involve machine learning or AI, thus there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. As there is no training set for a machine learning model, this question is not relevant.
Summary of the Study Proving Acceptance Criteria:
The "study" proving the device meets acceptance criteria is a series of laboratory tests and analyses demonstrating compliance with recognized standards. Specifically:
- The manufacturer performed tests on the Biogel Eclipse Indicator Underglove to ensure it Meets ASTM D3577 for characteristics such as dimensions, physical properties, and freedom from holes.
- Biocompatibility tests (Primary Skin Irritation and Guinea Pig Sensitization) were conducted and the device received a "Pass," indicating it meets established safety standards.
- The total water extractable protein content was measured and found to be "50 micrograms or less per gram," meeting the specified threshold.
The overall conclusion is that "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." This indicates that the device has undergone the necessary testing to demonstrate its performance and safety against established industry standards for surgical gloves.
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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, LLC5550 Peachtree Parkway Suite 500Norcross, GA 30092 |
|---|---|
| 2. Contact Person: | Steven Dowdley, RACDirector of Regulatory AffairsTel.: 678-250-7930Fax: 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 GloveK053443 - 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.
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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.
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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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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
§ 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).