(65 days)
Not Found
Not Found
No
The device description and intended use clearly define a standard medical glove with no mention of AI or ML capabilities. The performance studies focus on physical properties and biocompatibility, not algorithmic performance.
No
The device, a medical glove, is intended for barrier protection to prevent contamination, not to treat or directly manage a medical condition.
No
Explanation: The device is a medical glove intended for preventing contamination, not for diagnosing any medical condition.
No
The device is a physical medical glove, not a software-only device. The description focuses on the material and physical properties of the glove.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prevent contamination between healthcare personnel and the patient by being worn on the hands. This is a barrier function, not a diagnostic function.
- Device Description: The description focuses on the physical properties and standards met by the glove (dimensions, physical properties, freedom from pinholes, powder-free). These are characteristics of a barrier device, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies mentioned are related to physical properties and biocompatibility (skin irritation and sensitization), which are relevant for a medical glove, not an IVD.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic purposes. This glove does not perform such a function.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
LZA
Device Description
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):
- 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
Biocompatibility:
- Primary Skin Irritation in Rabbits: Passes
- Guinea Pig Sensitization: Passes
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
hands
Indicated Patient Age Range
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Intended User / Care Setting
healthcare and similar personnel
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance test data that support a determination of substantial equivalence are described above.
It can be concluded that the Safeskin Polymer-Coated Nitrile Examination Glove will perform according to the glove performance standards referenced in Section 7 and the labeling claims for the above and therefore will this device is substantially equivalent to currently marketed devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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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
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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 -
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