(95 days)
The Biogel® 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® 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 510(k) summary describes the Biogel® Indicator™ Underglove, a sterile powder-free latex surgical glove. The device is classified as a Class I surgical glove (CFR 878.4461).
Here's an analysis of the provided information covering the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimensions | Meets ASTM D3577 | Meets ASTM D3577 |
| Physical Properties | Meets ASTM D3577 | Meets ASTM D3577 |
| Freedom from Holes | Meets ASTM D3577 | Meets ASTM D3577 |
| Biocompatibility | Meets ISO 10993-1 | Meets ISO 10993-1 |
| LAL Test - final endotoxin concentration | < 0.25 EU/ml | < 0.25 EU/ml |
| Protein Content | 50 micrograms or less of total water extractable protein per gram | 50 micrograms or less of total water extractable protein per gram |
| Non-pyrogenic Claim | Implied by "non-pyrogen statement" and "LAL Test" results | Device is Biogel® Indicator™ Underglove with non-pyrogen statement |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not explicitly state the sample size used for testing each characteristic. Given that the compliance is stated as "Meets ASTM D3577" and "Meets ISO 10993-1," it is understood that standard testing protocols for these specifications would have been followed, which inherently include defined sample sizes for each test. For example, ASTM D3577 specifies sampling plans for inspection of dimensions, physical properties, and freedom from holes.
The data provenance is not explicitly mentioned (e.g., country of origin, retrospective or prospective). However, as these are technical performance tests against established standards (ASTM, ISO), the testing would typically be performed in a laboratory setting under controlled conditions.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
For performance tests against established industry standards (ASTM D3577, ISO 10993-1), the "ground truth" is the standard itself. These standards define objective, measurable criteria. Therefore, the concept of "experts establishing ground truth" in the same way as, for example, diagnostic image interpretation, does not directly apply here.
The "experts" involved would be the laboratory technicians and qualified personnel who conduct the tests according to the standard procedures and interpret the results against the specified limits. Their qualifications would include training and certification in performing these specific ASTM and ISO tests.
4. Adjudication Method for the Test Set
Adjudication methods like '2+1' or '3+1' are typically used for subjective assessments (e.g., medical image interpretation consensus). Since the device's performance is measured against objective, quantitative standards (ASTM D3577, ISO 10993-1, LAL test), an adjudication method in this context does not apply. The test results are either within the specified limits of the standard or they are not.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No MRMC comparative effectiveness study was done. The device is a surgical glove, and the evaluation focuses on its physical properties, biocompatibility, and barrier integrity as defined by objective standards, not on human interpretive tasks that would benefit from an MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The device is a physical product (a surgical glove), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used
The ground truth used for evaluating the device's performance is established industry and international standards (ASTM D3577, ISO 10993-1), along with the specific product claim for protein content (50 micrograms or less) and endotoxin concentration (<0.25 EU/ml). These are objective, measurable criteria.
8. The Sample Size for the Training Set
This question is not applicable. The device is a physical product, not an AI model or software algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This question is not applicable. As stated above, there is no "training set" for this type of device submission.
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| 1. | 510(k) SUMMARYApplicant: | SEP 10 2007Mölnlycke Health Care US, LLC5550 Peachtree Parkway Suite 500Norcross, GA 30092 |
|---|---|---|
| 2. | Contact Person: | Steven Dowdley, RACDirector of Regulatory Affairs, Molnlycke Health Care, US LLCTel.: 678-250-7930Fax: 678-250-7979 |
| or | ||
| Marcia K. Ash, RACMKA ConsultingTel: 404-906-0492 | ||
| 3. | Device Name: | Biogel® Indicator™ Underglove with non-pyrogen statement |
| Common Name:Classification: | Surgical Glove (CFR 878.4461)Class I | |
| 4. | Predicate Device : | K980942 - Biogel® Indicator™ Underglove |
| K060030 - Eclipse, Non-pyrogenic, Latex, Powder-free, Glove | ||
| 5. | Device Description: | The Biogel® Indicator™ Underglove is a sterile powder free,polymer coated latex surgical glove. The glove contains 50micrograms or less of total water extractable protein per gram. |
| 6. | Intended Use of the Device: | The Biogel® Indicator™ Underglove is a disposable devicemade of natural rubber latex that is intended to be worn on thehands, usually in a surgical setting, to provide a barrier againstpotentially infectious material and other contaminants. |
| 7. | Technological Characteristics of theDevice: | The Biogel® Indicator™ Underglove characteristics aresummarized below as compared to ASTM requirements and tothe predicate devices. |
| CharacteristicDimensionsPhysical PropertiesFreedom from HolesBiocompatibilityLALTest - final endotoxinconcentration | StandardMeets ASTM D3577Meets ASTM D3577Meets ASTM D3577Meets ISO 10993-1<0.25EU/ml | |
| 8. | Performance Data | The performance data are summarized above. |
| 9. | Clinical Data | No clinical data was required. |
| 10. | Conclusion: | The Biogel® Indicator™ Underglove meets thetechnological characteristics of ASTM D3577 and issubstantially equivalent to the predicate devices cited in this 510(k) summary. |
Mölnlycke Health Care
5550 Peachtree Parkway, Suite 500
Norcross, GA 30092 USA
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is a stylized symbol featuring three profiles facing to the right, representing the human aspect of the department's work.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 0 2007
Mr. Steven Dowdley, RAC Director of Regulatory Affairs Mölnlycke Health Care US, LLC 5550 Peachtree Parkway, Suite 500 Norcross, Georgia 30092
Re: K071565
Trade/Device Name: Biogel Powder-Free Latex Indicator Surgical Underglove, with Protein Content Labeling Claim (50micrograms or less) & with Non-Pyrogenic Claim Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove
Regulatory Class: I Product Code: KGO
Dated: August 26, 2007
Received: August 28, 2007
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 yours,
Chiu-Lin, Ph.D.
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
Enclosure
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3.0 Indications for Use Statement:
Applicant: Molnlycke Heath Care US, LLC
510(k) Number: K071565
Biogel Powder-Free Latex Indicator Surgical Underglove, with Protein Content Device Name: Labeling Claim (50micrograms or less) & with Non-Pyrogenic Claim
Indication for Use:
The Biogel® 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 _ Per 21 CFR 801.109 Or Over-The-Counter _ . . . X
Shada A. Murphey 16
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K071575
§ 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).