(46 days)
A medical glove intended to be worn on the hands of healthcare and similar personnel to prevent contamination between such personnel and the patient.
Safeskin Synthetic Powder-Free Examination Gloves are disposable medical gloves intended to be worn by healthcare and similar personnel to prevent contamination between such personnel and the patient.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:
The provided document is a 510(k) summary for a medical device, specifically Safeskin Synthetic Powder-Free Examination Gloves. It focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive study proving novel performance. Therefore, many of the requested fields related to clinical studies and AI performance will not be applicable.
1. A table of acceptance criteria and the reported device performance
| Characteristics | Acceptance Criteria (Standards) | Reported Device Performance |
|---|---|---|
| Dimensions | Meets ASTM D 5250 | Meets ASTM D 5250 |
| Physical Properties | Meets ASTM D 5250 | Meets ASTM D 5250 |
| Freedom from pinholes | Meets ASTM D 5250; Meets ASTM D 5151 | Meets ASTM D 5250; 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 in Rabbits | Pass | Passes |
| Guinea Pig Sensitization | Pass | Passes |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes used for testing to demonstrate compliance with ASTM standards. The data provenance is also not specified, only that "The performance test data that support a determination of substantial equivalence are described above." This typically implies testing conducted by the manufacturer. It is a retrospective summary of tests performed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. The ground truth for this type of device (examination gloves) is established through adherence to standardized physical and chemical testing methods (ASTM standards), not through expert consensus on images or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically used in clinical studies or image-based diagnostic evaluations. Compliance with ASTM standards involves objective measurements and defined pass/fail criteria, not subjective 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 device is a medical glove, not an AI-powered diagnostic tool. Therefore, MRMC studies and AI assistance are irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a medical glove, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth is established by objective measurements against established industry standards (ASTM D 5250-99, ASTM D 5151, ASTM D 6124) as well as biocompatibility testing standards (Primary Skin Irritation in Rabbits, Guinea Pig Sensitization).
8. The sample size for the training set
Not applicable. This device is a physical product (medical glove), not a machine learning model, so there is no concept of a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
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JUL 26 1999 June 9, 1999
K99 L9S]
- [1] 510(k) Summary of Safety and Effectiveness Information
- [2] Safeskin Corporation 12671 High Bluff Drive San Diego, CA 92130
Telephone: 619-509-7010 Fax: 619-350-2382
Contact: Eugene V. Goorchenko Telephone: 619-509-7010 619-350-2382 Fax:
- [3] Trade Name: Safeskin Synthetic Powder-Free Examination Gloves Common Name: Patient Examination Gloves Classification Name: Patient Examination Gloves
- [4] The predicate is a powder-free synthetic (vinyl) examination glove which meets all of the requirements of ASTM D 5250-99.
- [૨] The Safeskin Synthetic Powder-Free Examination Glove will meet all the current specifications for ASTM D 5250-99, vinyl examination gloves.
- [୧] Safeskin Synthetic Powder-Free Examination Gloves are disposable medical gloves intended to be worn by healthcare and similar personnel to prevent contamination between such personnel and the patient.
- [7] Safeskin® Synthetic Powder-Free Examination Gloves possess the following technological characteristics (as compared to ASTM or equivalent standards):
| Characteristics | Standards |
|---|---|
| Dimensions | Meets ASTM D 5250 |
| Physical Properties | Meets ASTM D 5250 |
| Freedom from pinholes | Meets ASTM D 5250Meets ASTM D 5151 |
| Powder-Free | Meets ASTM D 61242 mg/glove maximum |
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Biocompatability
| Primary Skin Irritation in Rabbits | Passes |
|---|---|
| Guinea Pig Sensitization | Passes |
- The performance test data that support a determination of substantial equivalence [8] are described above.
- Clinical data are not needed for surgical gloves. [9]
- It can be concluded that the Safeskin® Synthetic Powder-Free Examination 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 is a black and white circular logo for the Department of Health & Human Services - USA. The logo features the department's name encircling a symbol. The symbol consists of three stylized human profiles facing right, stacked on top of each other, with flowing lines suggesting movement or connection.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 26 1999
Mr. Eugene V. Goorchenko Director of Regulatory Affairs Safeskin Corporation 12671 High Bluff Drive San Diego, California 92130
Re : K991951 Safeskin Synthetic Vinyl Powder-Free Polymer Trade Name: Coated Examination Gloves (green, white) Requlatory Class: I Product Code: LYZ Dated: June 9, 1999 Received: June 10, 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, qood 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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Goorchenko
Please note: this response to your premarket notification submission does not affect any 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 regulation entitled, "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.fdaf.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director
Directbr Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
Safeskin Corporation Applicant:
Kg91951 510(k) Number:
Device Name: Viral Synthetic powder-free examination glove of
Indications for Use:
A medical glove intended to be worn on the hands of healthcare and similar personnel to prevent contamination between such personnel and the patient.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Over-The-Counter
Olin S. Lin
510(k) Number
9
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination 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). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.