(123 days)
The Skinsense Polyisoprene Underglove is a disposable device made of non-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 Skinsense Polyisoprene 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 is a 510(k) summary for a medical device called the "Skinsense Polyisoprene Underglove." It describes characteristics and performance data related to physical properties and biocompatibility.
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: | ||
| Cytotoxicity Study | Pass | Pass |
| ISO Skin Irritation Study | Pass | Pass |
| LAL Test | <0.25 EU/ml (presumably) | <0.25 EU/ml |
Note: For the LAL Test, the acceptance criterion specifically states "<0.25 EU/ml" which is also presented as the reported performance, implying this is the established threshold.
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for testing each characteristic. It lists the tests performed (e.g., Cytotoxicity Study, ISO Skin Irritation Study, LAL Test, and conformance to ASTM D3577 for Dimensions, Physical Properties, and Freedom from Holes). The data provenance is not explicitly stated in terms of country of origin or whether it's retrospective or prospective. It is implied that these are lab-based tests conducted to demonstrate compliance with standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This document describes performance testing against established standards (ASTM D3577) and biocompatibility tests, not the interpretation of complex data requiring expert consensus for a "ground truth" in the way it might for AI diagnostic tools. Therefore, the concept of "number of experts used to establish the ground truth" with specific qualifications is not applicable in this context. The "ground truth" is defined by the objective criteria within the ASTM standard and the pass/fail thresholds for the biocompatibility tests.
4. Adjudication method for the test set
Not applicable. This is not a study involving human readers or subjective interpretations requiring adjudication. The performance is determined by objective measurements against predefined standards and thresholds.
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 is not a study of an AI-assisted diagnostic device, but rather a
summary for a surgical glove.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This document is for a physical medical device (surgical glove), not a standalone algorithm.
7. The type of ground truth used
The "ground truth" for the performance data in this document is defined by:
- Established Industry Standards: ASTM D3577-01-ae2, which specifies requirements for various characteristics of surgical gloves.
- Biocompatibility Test Pass/Fail Criteria: Standardized protocols for Cytotoxicity, ISO Skin Irritation, and LAL (Endotoxin) tests with defined pass/fail thresholds.
8. The sample size for the training set
Not applicable. This document is for a physical medical device and does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
Not applicable, as there is no training set involved for this device.
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Molnlycke Heath Care US, LLC 5550 Peachtree Parkway, Suite 500 Norcross, GA. 30092
Koyllso
IG 2 6 200
510(k) SUMMARY
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- Applicant:
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- Contact Person:
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- Device Name: Common Name: Classification:
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- Predicate Device : Device Description:
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- Intended Use of the Device:
- Technological Characteristics of the Device:
Characteristic Dimensions Physical Properties Freedom from Holes Biocompatibility Cytotoxiciity Study ISO Skin Irritation Study LAL Test
- Performance Data
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- Clinical Data
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- Conclusion:
Mölnlycke Health Care US, LLC 5550 Peachtree Parkway Suite 500 Norcross, GA 30092
Steven Dowdley, RAC Director of Regulatory Affairs Tel.: 678-250-7930 678-250-7979 Fax:
Skinsense Polyisoprene Underglove Surgical Glove (CFR 878.4461) Class I
The Skinsense Polyisoprene 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.
The Skinsense Polyisoprene 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 Skinsense Polyisoprene Underglove characteristics are summarized below as compared to ASTM requirements and to the predicate devices.
Standard Meets ASTM D3577 Meets ASTM D3577 Meets ASTM D3577
Pass Pass <0.25EU/ml. The performance data are summarized above.
No clinical data was required.
The Skinsense Polyisoprene Underglove meets the technological characteristics of ASTM D3577-01-ae2 and is substantially equivalent to the predicate devices identified in sited in this 510(k) summary.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Steven Dowdley Director of Regulatory Affairs Mölnlycke Health Care US, LLC 5550 Peachtree Parkway, Suite 500 Norcross, Georgia 30092
AUG 2 6 2008
Re: K081180
Trade/Device Name: Skinsense Polyisoprene Underglove Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: Class I Product Code: KGO Dated: August 13, 2008 Received: August 15, 2008
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.
CluG
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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Molnlycke Heath Care US, LLC 5550 Peachtree Parkway, Suite 500 Norcross, GA. 30092
3.0
INDICATION FOR USE
Applicant: Molnlycke Heath Care US, LLC
510(k) Number:
Device Name: Skinsense Polyisoprene Underglove
Indication for Use:
The Skinsense Polyisoprene Underglove is a disposable device made of non-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 X
Per 21 CFR 801.109
Shule M. Mymberyke
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K081180
§ 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).