(65 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.
The Safeskin Polymer-Coated Nitrile Examination Glove are sterile disposable devices intended to be worn by healthcare and similar personnel to prevent contamination between personnel and the patient. The Safeskin Polymer-Coated Nitrile Examination Glove possesses the following technological characteristics (as compared to ASTM or equivalent standards): Dimensions Meets ASTM D 3578-99, Physical Properties Meets ASTM D 3578-99, Freedom from pinholes Meets ASTM D 5151, Powder-Free Meets ASTM D 6124 2 mg/glove maximum.
The provided text describes the 510(k) premarket notification for the "Safeskin Polymer-Coated Nitrile Examination Glove." This document focuses on demonstrating substantial equivalence to a predicate device by meeting established performance standards for examination gloves.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ASTM D 3578-99 Dimensions | Meets ASTM D 3578-99 Dimensions |
| ASTM D 3578-99 Physical Properties | Meets ASTM D 3578-99 Physical Properties (with the exception of elongation) |
| ASTM D 3578-99 Freedom from pinholes | Meets ASTM D 3578-99 Freedom from pinholes |
| ASTM D 5151 (Freedom from pinholes) | Meets ASTM D 5151 |
| ASTM D 6124 Powder-Free | Meets ASTM D 6124 (2 mg/glove maximum) |
| Biocompatibility (Primary Skin Irritation in Rabbits) | Passes |
| Biocompatibility (Guinea Pig Sensitization) | Passes |
Note: The text explicitly states that the device meets ASTM D 3578-99 with the exception of elongation. It then reiterates that it meets "ASTM D 3578-99 Physical Properties" but implies this exception still applies, as it was mentioned earlier in the same paragraph.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the tests to meet the ASTM standards or biocompatibility tests. It also does not mention the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Those Experts
This information is not applicable to this type of device submission. The "ground truth" for examination gloves is defined by adherence to established industry performance standards (ASTM standards) and biocompatibility tests, not by expert consensus on interpretations.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods are typically used in studies involving human interpretation (e.g., medical imaging) to resolve discrepancies in expert opinions. Here, the assessment is against objective physical and chemical standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not performed. This type of study is relevant for AI-powered diagnostic devices where the AI assists human readers. This device is a medical glove.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone performance assessment is not applicable. This device is a simple physical barrier, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used is based on established industry performance standards (ASTM standards) and biocompatibility testing results. These standards define the acceptable physical properties, freedom from defects, and biological safety of the examination glove.
8. The Sample Size for the Training Set
This information is not applicable as this device does not involve a training set. Machine learning algorithms, which require training sets, are not used in the development or evaluation of this simple medical device.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for this device.
Summary of the Study:
The study proving the device meets acceptance criteria is a series of standardized laboratory tests. These tests evaluate the physical properties, integrity (freedom from pinholes), powder content, and biocompatibility of the "Safeskin Polymer-Coated Nitrile Examination Glove" against the specified ASTM (American Society for Testing and Materials) standards. The document states that the glove "will meet the current specifications" for ASTM D 3578-99 (with the exception of elongation), ASTM D 5151, and ASTM D 6124, and "Passes" biocompatibility tests. The specific details of these tests (e.g., number of gloves tested for pinholes, the exact methodology for physical property measurement) are not provided in this summary but would be part of the full submission. The document concludes that these performance test data support a determination of substantial equivalence to a predicate device.
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001 27 1999
CONFIDENTIAL Safeskin Corporation
FDA 510(k), Premarket Notification
August 20, 1999
- 510(k) Summary of Safety and Effectiveness Information [1]
- Safeskin Corporation [2] 12671 High Bluff Drive San Diego, CA 92130
619-794-8111 Telephone: 619-350-2382 Fax:
| Contact: | Eugene V. Goorchenko |
|---|---|
| Telephone: | 619-509-7010 |
| Fax: | 619-350-2382 |
- Trade Names: "Safeskin Polymer-Coated Nitrile Examination Glove" and [3] Trade Names: "Saleskill Folyme", Powder-Free Patient Examination Gloves Common Name: Common Name: Patient Examination Gloves
- The predicate is a Safeskin blue nitrile examination glove which meets all of the The predicate is a Safeskin blue nitrue exammation glove in the least of the best in the Examination
requirements of ASTM D 3578-99, Standard Specification for Nitrile Examin [4] Gloves for Medical Application. - The Safeskin Polymer-Coated Nitrile Examination Glove will meet the current of elongation). The Safeskin Polymer-Coated Nitrile Examination of elongation).
specifications for ASTM D 3578-99 (with the exception of elongation). [ર] - The Safeskin Polymer-Coated Nitrile Examination Glove are sterile disposable
s of the same of the collections and similar personnel to prevent The Safeskin Polymer-Coated Nitrile Loadmandinian personnel to prevent
devices intended to be worn by healthcare and similar personnel to prevent [୧] devices intended to be worn by systemnel and the patient. - The Safeskin Polymer-Coated Nitrile Examination Glove possesses the following
er of the finance of the founders and to ASTM or equivalent standards): [7] The Safeskin Polymer-Coated Nittle Exammared to ASTM or equivalent standards):
technological characteristics (as compared to ASTM or equivalent standards):
Stephological char Standards Characteristics Meets ASTM D 3578-99 Dimensions Meets ASTM D 3578-99 Physical Properties Meets ASTM D 3578-99 Freedom from pinholes Meets ASTM D 5151 Meets ASTM D 6124 Powder-Free 2 mg/glove maximum
70
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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 examination gloves. (a)
- It can be concluded that the Safeskin Polymer-Coated Nitrile Examination Glove [10] If can be concluded that the salessur Formance standards referenced in Section 7
will perform according to the glove performance standards charize also the will perform according to the glove periorments and the labeling claims for the above and therefore will his 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 stylized caduceus symbol, which is a staff with two snakes coiled around it, topped by a bird. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 27 1999
Mr. Eugene V. Goorchenko Director of Requlatory Affairs Safeskin Corporation 12671 High Bluff Drive San Diego, California 92130
Re : K992830
Safeskin Polymer-Coated Nitrile Examination Trade Name: Gloves Regulatory Class: I Product Codc: LZA Dated: August 20, 1999 Received: August 23, 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 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 (Premarket Approval), 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 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. 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 regulation (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 qeneral 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,
Clifford
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Safeskin Corporation
FDA 510(k), Premarket Notification
INDICATIONS FOR USE
Safeskin Corporation Applicant:
K 992830 510(k) Number:
Powder-free polymer-coated nitrile examination glove, purple or Device Names: whitc
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
Clim S. Lin
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital D 5100kt Number -
10
§ 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.