(164 days)
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Not Found
No
The summary describes a physical examination glove and does not mention any software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as an "examination glove" used to prevent contamination, not to treat a medical condition or disease.
No
Explanation: The device is described as a medical examination glove intended to prevent contamination. There is no mention of it being used to detect, diagnose, monitor, or treat any medical condition.
No
The device is a physical examination glove, which is a hardware medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the glove is for preventing contamination between healthcare personnel and patients and for use with chemotherapeutic agents. This is a barrier function, not a diagnostic function performed in vitro (outside the body).
- Device Description: The description reinforces the barrier function and use with chemotherapeutic agents.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
- Anatomical Site: The device is worn on the hands, which is a physical barrier application, not a site for in vitro diagnostic testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This glove does not fit that description.
N/A
Intended Use / Indications for Use
A medical examination glove intended to be worn on the hands of healthcare personnel and similar personnel to prevent contamination between such personnel and the patient and for use with chemotherapeutic agents.
Product codes
LYY
Device Description
The Safeskin PFE-XTRA Examination Glove is a disposable device intended to be worn by healthcare and similar personnel to prevent contamination between such personnel and the patient and for use with chemotherapeutic agents.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare personnel and similar personnel
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
The performance test data that support a determination of substantial equivalence are described above.
Key Metrics
Not Found
Predicate Device(s)
a Safeskin powder free examination glove which meets all of the requirements of ASTM D 3578-00, Standard Specification for Rubber Examination Gloves for Medical Application.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
FDA 510(k), Premarket Notification
MAR - 2 2000
K993117
Safeskin Corporation
September 1, 1999
- 510(k) Summary of Safety and Effectiveness Information [1]
- [2] Safeskin Corporation 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 PFE-XTRA Latex Examination Glove" [3] Common Name: Patient Examination Glove Classification Name: Patient Examination Glove
- The predicate is a Safeskin powder free examination glove which meets all of the [4] requirements of ASTM D 3578-00, Standard Specification for Rubber Examination Gloves for Medical Application.
- [૨] The Safeskin PFE-XTRA Examination Glove will meet all the current specifications for ASTM D 3578-99.
- [୧] The Safeskin PFE-XTRA Examination Glove is a disposable device intended to be worn by healthcare and similar personnel to prevent contamination between such personnel and the patient and for use with chemotherapeutic agents.
- [7] The Safeskin PFE-XTRA Examination Glove posesses the following technological characteristics (as compared to ASTM or equivalent standards):
| Characteristics | Standards |
|---|---|
| Dimensions | Meets ASTM D 3578-99 |
| Physical Properties | Meets ASTM D 3578-99 |
| Freedom from pinholes | Meets ASTM D 3578-99 |
| Meets ASTM D 5151 | |
| Powder-Free | Meets ASTM D 6124 |
| 4 mg/glove maximum |
1
Biocompatability
Primary Skin Irritation in Rabbits Passes Passes Guinea Pig Sensitization
- [8] The performance test data that support a determination of substantial equivalence are described above.
- [a] Clinical data are not needed for examination gloves.
- [10] It can be concluded that the Safeskin PFE-XTRA Examination Glove is safe and effective for use with chemotherapeutic agents and will perform according to the glove performance standards referenced in Section 7 above, thereby meeting ASTM standards, FDA requirements, and the labeling claims for the product. · Consequently, this device is substantially equivalent to currently marketed devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a symbol that resembles three stylized human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 2 2000
Mr. Eugene V. Goorchenko Director of Regulatory Affairs Safeskin Corporation 12671 High Bluff Drive San Diego, California 92130
Re : K993117
Trade Name: Safeskin Pfe-xtra® Latex Examination Glove with Protein Labelinq Claim (50 microgram or less) Regulatory Class: I Product Code: LYY December 29, 1999 Dated: December 30, 1999 Received:
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 registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 affectinq your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturinq 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
3
Paqe 2 -Mr. Goorchenko
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 diaqnostic devices), please contact the Office of Compliance at (301) 594-4690. 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.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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| Page | of |
|---|---|
| ------ | ---- |
INDICATIONS FOR USE Applicant: Safeskin Corporation 510(k) Number (if known):
Device Namc:_Safeskin_PFE=XTRA_Powder=Free_Latex_Examination Glove With Protein Claim 50 mcg or less Indications For ! ِڪ:
A medical examination glove intended to be worn on the hands of healthcare personnel and similar personnel to prevent contamination between such personnel and the patient and for use with chemotherapeutic agents.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Clim S. Lòn
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