(85 days)
A surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. (21CFR 878.4460)
sempermed® DERMA plus is a powdered surgeon's glove and it is a disposable device made of natural rubber inside coated with synthetic latex material that bears powder to facilitate donning and it is intended to be worn on the hands usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants. The glove is powdered with absorbable dusting powder USP Grade
The provided text is a 510(k) summary for the Sempermed Derma Plus Powered Latex Surgeon's Gloves. The document states that the device is substantially equivalent to a predicate device, "Supreme" Sempermed® Latex Surgeon's gloves, powder-free (510k #K981096).
However, the 510(k) does not contain the specific detailed acceptance criteria and a study proving the device meets those criteria in a format that can be extracted into the requested table. Instead, it relies on a comparison of technological characteristics to establish substantial equivalence to the predicate device.
Here's an analysis based on the information provided regarding the requested points:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a table with explicit acceptance criteria (e.g., minimum tensile strength, maximum protein content, AQL for pinholes) and numerical performance data for the Sempermed Derma Plus gloves to compare against those criteria.
Instead, it states:
- Performance: Identical (to the predicate device)
- Mechanical Safety: Identical (to the predicate device)
- Chemical Safety: Identical (to the predicate device)
- Biocompatibility: Identical (to the predicate device)
- Sterility: Identical (to the predicate device)
This implies that the device is expected to meet the same performance standards as the predicate device, but the specific numerical criteria and test results are not detailed in this 510(k) summary. The summary refers to "additional technical comparative table within 510K submission" for a more detailed comparison, which is not included in the provided text.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified in the provided text, beyond the submitter's location (Vienna, Austria). There is no mention of retrospective or prospective study data for a primary test set. The claim relies on the identity of the physical and chemical properties of the device relative to the predicate device to establish equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the submission is a 510(k) for substantial equivalence of a physical medical device (surgical gloves). It does not involve diagnostic image analysis or similar tasks that would require expert-established ground truth. The "ground truth" here would be objective physical and chemical testing results, which are not detailed.
4. Adjudication method for the test set:
This information is not applicable for the same reasons as point 3.
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:
This information is not applicable. This is a submission for a physical medical device (surgical gloves), not an AI-powered diagnostic tool. Therefore, MRMC studies and AI assistance are irrelevant to this submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable. This is a physical medical device, not an algorithm or AI.
7. The type of ground truth used:
For a physical device like surgical gloves, the "ground truth" would typically refer to objective measurements of physical properties (e.g., tensile strength, elongation, barrier integrity assessed by leak tests, protein content) and chemical properties (e.g., types of materials used, powder content). The 510(k) summary indicates that the "Performance," "Mechanical safety," "Chemical safety," "Biocompatibility," and "Sterility" are "Identical" to the predicate device, implying that the ground truth for these aspects was established through appropriate testing methods for both the new device and the predicate. However, detailed results or the specific "type" (e.g., specific test standards or laboratory results) are not provided in this summary.
8. The sample size for the training set:
This information is not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established:
This information is not applicable for the same reasons as point 8.
{0}------------------------------------------------
Ka2819
510(k) Summary NOV 1 6 2001 As Required by 21 section 807.92 ( c )
| 1-Submitter Name: | Semperit Technische Produkte GmbH & Co KG |
|---|---|
| 2-Address: | Modecentraße 22A-1031 Vienna AUSTRIA |
| 3-Phone: | (++43) 2630 310 216 |
| 4-Fax: | (++43) 2630 310 479 |
| 5-Contact Person: | Dipl.-Ing. Richard Ehrenfeldner |
| 6-Date summary prepared: | August 18th, 2001 |
| 7- Official Correspondent: | Mansour Consulting |
| 8- Address: | 1308 Morningside Park DrAlpharetta, GA 30022 USA |
| 9- Phone: | (678) 908-8180 |
| 10- Fax: | (425) 795-9341 |
| 11- Contact person: | Jay Mansour, president |
| 12-Device Trade or Proprietary Name: | sempermed® Derma Plus |
| 13-Device Common or usual name: | Surgeon's glove |
| 9-Device Classification Name: | Surgeon's glove |
| 10-Substantial Equivalency is claimed against the following device: | "Supreme" Sempermed® Latex Surgeon's gloves, powder-free510k #K981096 (refer to Appendix 2 for FDA notification letterThis notification for the sempermed® DERMA plus is of theABBREVIATED type as per the declaration of conformity on page 4 |
of this summary
11-Description of the Device:
sempermed® DERMA plus is a powdered surgeon's glove and it is a disposable device made of natural rubber inside coated with synthetic latex material that bears powder to facilitate donning and it is intended to be worn on the hands usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants. The glove is powdered with absorbable dusting powder USP Grade
12-Intended use of the device: {Indications for use typed on a separate FDA form)
sempermed® DERMA plus is a powdered surgeon's glove and it is a disposable device made of natural rubber inside coated with synthetic latex material that bears powder to facilitate donning and it is intended to be worn on the hands usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants. The glove is powdered with absorbable dusting powder USP Grade
13-Safety and effectiveness of the device:
The sempermed® DERMA plus is safe and effective as the predicate device "Supreme" Sempermed® Latex Surgeon's gloves, powder-free. Indeed, it is equivalent
This is better expressed in the tabulated comparison (Paragraph 14 below) PAGE 3.1
{1}------------------------------------------------
14-Summary comparing technological characteristics with other predicate device:
General comparison result between sempermed® DERMA plus gloves and the predicate device (sempermed® SUPREME) is tabulated below.
Technical comparison of specific elements is attached in the main submission
| FDA file reference number | 510k 981096 |
|---|---|
| Attachments inside notificationsubmission file | REFER TO APPENDIX 2 |
| TECHNOLOGICALCHARACTERISTICS | Comparison resultREFER TO ADDITIONAL TECHNICALCOMPARATIVE TABLE WITHIN 510K SUBMISSION |
| Indications for use | Identical |
| Target population | Identical |
| Design | Similar |
| Materials | Identical |
| Performance | Identical |
| Sterility | Identical |
| Biocompatibility | Identical |
| Mechanical safety | Identical |
| Chemical safety | Identical |
| Anatomical sites | Identical |
| Human factors | Identical |
| Energy used and/or delivered | Identical (not applicable) |
| Compatibility withenvironment and other devices | Identical |
| Where used | Identical |
| Standards met | Identical |
| Electrical safety | Identical (not applicable) |
| Thermal safety | Identical (not applicable) |
| Radiation safety | Identical (not applicable) |
.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Semperit Technische Produkte Gesellshaft C/O Mr. Jay Mansour Official Correspondent Mansour Consulting 1308 Morningstar Park Drive Apharetta, Georgia 30022
Re: K012819
Trade/Device Name: Sempermed Derma Plus Powered Latex Surgeon's Gloves Regulation Number: 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: August 23, 2001 Received: August 23, 2001
NOV 1 6 2001
Dear Mr. Mansour:
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.
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
{3}------------------------------------------------
Page 2 - Mr. Mansour
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
K.C. Lilient
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
NOV 1 6 2001
Indication for Use Statement
Applicant: Semperit Technische Produkte Gesellshaft
510(k) Number (if known):_K012819
Device Name: Sempermed Dcrnia Plus Powdered Latex Surgeon's Gloves
Indications For Use:
A surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. (21CFR 878.4460)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Qien S. Lim
(Division Sign-Off) vision of Dental, Infection Control, Ceneral Hospital (ik) Number
§ 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).