(46 days)
A surgeon's glove is intended to be worn on the hands of operating room personnel to prevent contamination between such personnel and the patient during a surgical procedure.
Safeskin Tactylon® PF powder-free surgical gloves are sterile disposable devices intended to be worn by operating room personnel to prevent contamination between such personnel and the patient during a surgical procedure. Safeskin® Tactylon PF powder-free surgical gloves possess the following technological characteristics (as compared to ASTM or equivalent standards): Dimensions Meets ASTM D 3577, Physical Properties Meets ASTM D 3577, Freedom from pinholes Meets ASTM D 3577 Meets ASTM D 5151, Powder-Free Meets ASTM D 6124 2 mg/glove maximum.
The provided document is a 510(k) Premarket Notification for a medical device, specifically a surgical glove. It does not describe an AI/ML powered device, nor does it detail a clinical study with an AI component. Therefore, much of the requested information regarding AI acceptance criteria, sample sizes for AI training/test sets, expert ground truth, MRMC studies, or standalone algorithm performance is not applicable.
However, I can extract information related to the acceptance criteria and the study (or lack thereof) to prove the device meets these criteria as presented in the document for the physical device.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Acceptance Criteria (Standards) | Reported Device Performance |
|---|---|---|
| Dimensions | Meets ASTM D 3577 | Meets ASTM D 3577 |
| Physical Properties | Meets ASTM D 3577 | Meets ASTM D 3577 |
| Freedom from pinholes | Meets ASTM D 3577 & Meets ASTM D 5151 | Meets ASTM D 3577 & Meets ASTM D 5151 |
| Powder-Free | Meets ASTM D 6124 (2 mg/glove maximum) | Meets ASTM D 6124 (2 mg/glove maximum) |
| Primary Skin Irritation | Passes in Rabbits (Biocompatibility) | Passes |
| Guinea Pig Sensitization | Passes (Biocompatibility) | Passes |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for the individual tests (e.g., how many gloves were tested for pinholes, or how many rabbits/guinea pigs were used). It implicitly refers to compliance with ASTM standards, which would dictate appropriate sampling methods.
The data provenance is not explicitly stated as "country of origin" for testing, but the company is based in San Diego, CA, USA, and the submission is to the US FDA. The testing described is intrinsic to the product's physical and biocompatibility characteristics, not clinical data provenance in the sense of patient records.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable as this is a physical device (surgical glove) meeting manufacturing standards, not a diagnostic or AI device requiring expert-established ground truth from medical images or data. The "ground truth" here is the pass/fail criteria defined by ASTM and biocompatibility standards.
4. Adjudication method for the test set
Not applicable. The tests are based on objective measurements against engineering and biological standards, not subjective expert assessment requiring adjudication.
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 a physical device submission and does not involve AI or human readers for diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical device submission and does not involve an algorithm.
7. The type of ground truth used
The "ground truth" for this device's performance is established by:
- ASTM (American Society for Testing and Materials) Standards: These are consensus standards for material properties and testing methods (e.g., D 3577 for rubber surgical gloves, D 5151 for detecting pinholes, D 6124 for powder residue).
- Biocompatibility Standards: These standards (implied by "Passes" for skin irritation and sensitization) ensure the material is safe for contact with human tissue.
8. The sample size for the training set
Not applicable. This is a physical device and the concept of a "training set" for an AI model does not apply. The manufacturing process is analogous to "training" in the sense of quality control and process optimization, but not in the AI context.
9. How the ground truth for the training set was established
Not applicable. As noted above, there is no AI training set. The "ground truth" for the device's acceptable quality is defined by adherence to established, external manufacturing and material standards (ASTM, biocompatibility).
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1994081
FDA 510(k), Premarket Notification
JAN 1 8 2000
December 2, 1999
- 510(k) Summary of Safety and Effectiveness Information [1]
- Safeskin Corporation [2] 12671 High Bluff Drive San Diego, CA 92130
Telephone: 858-509-7010 858-350-2382 Fax:
| Contact: | Eugene V. Goorchenko |
|---|---|
| Telephone: | 858-509-7010 |
| Fax: | 858-350-2382 |
- [3] Trade Name: Safeskin Tactylon® PF powder-free surgical gloves Surgical Gloves Common Name: Classification Name: Surgeon's Gloves
- The predicate is a Safeskin powdered synthetic surgical glove which meets all of [4] the requirements of ASTM D 3577.
- The Safeskin Tactylon® PF powder-free surgical glove will meet all the current [૨] specifications for ASTM D 3577, type 2 rubber surgical gloves.
- [୧] Safeskin Tactylon® PF powder-free surgical gloves are sterile disposable devices intended to be worn by operating room personnel to prevent contamination between such personnel and the patient during a surgical procedure.
- [7] Safeskin® Tactylon PF powder-free surgical gloves possess the following technological characteristics (as compared to ASTM or equivalent standards):
| Characteristics | Standards |
|---|---|
| Dimensions | Meets ASTM D 3577 |
| Physical Properties | Meets ASTM D 3577 |
| Freedom from pinholes | Meets ASTM D 3577Meets ASTM D 5151 |
| Powder-Free | Meets ASTM D 61242 mg/glove maximum |
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Biocompatibility
| Primary Skin Irritation in Rabbits | Passes |
|---|---|
| Guinea Pig Sensitization | Passes |
- [8] The performance test data that support a determination of substantial equivalence are described above.
- [9] Clinical data are not needed for surgical gloves.
- It can be concluded that the Safeskin® Tactylon PF powder-free surgical glove [10] will perform according to the glove performance standards referenced in Section 7 above and therefore will meet ASTM standards, FDA requirements, and the labeling claims for the product. Consequently, this device is substantially equivalent to currently marketed devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three curved lines representing its wings and body. The eagle is facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 8 2000
Mr. Eugene V. Goorchenko Director of Regulatory Affairs Safeskin Corporation 12671 High Bluff Drive San Diego, California 92130
Re: K994081
Safeskin Tactylon® PF Powder Free Surgeon's Trade Name: Glove Requlatory Class: I Product Code: KGO Dated: December 2, 1999 Received: December 3, 1999
Dear Mr. Goorchenko:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual reqistration, 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any
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Page 2 - Mr. Goorchenko
obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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 oriece of compriand, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director
Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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INDICATIONS FOR USE
| Applicant: | Safeskin Corporation | ||
|---|---|---|---|
| 510(k) Number: | K994081 |
Safeskin Tactylon® PF Powder Free Surgeon's Glove Device Name:
Indications for Use:
A surgeon's glove is intended to be worn on the hands of operating room personnel to prevent contamination between such personnel and the patient during a surgical procedure.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Ola S. Lim
Over-The-Counter
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
| 510(k) Number | K994081 |
|---|---|
| --------------- | --------- |
10
§ 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).