(164 days)
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.
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.
The Safeskin PFE-XTRA Latex Examination Glove underwent testing to demonstrate its substantial equivalence to predicate devices and adherence to relevant standards.
1. Acceptance Criteria and Reported Device Performance
| Characteristics | Standards (Acceptance Criteria) | Reported Device Performance |
|---|---|---|
| Dimensions | Meets ASTM D 3578-99 | Meets ASTM D 3578-99 |
| Physical Properties | Meets ASTM D 3578-99 | Meets ASTM D 3578-99 |
| Freedom from pinholes | Meets ASTM D 3578-99 | Meets ASTM D 3578-99 |
| Freedom from pinholes | Meets ASTM D 5151 | Meets ASTM D 5151 |
| Powder-Free | Meets ASTM D 6124 (4 mg/glove maximum) | Meets ASTM D 6124 (4 mg/glove maximum) |
| Primary Skin Irritation in Rabbits | Passes | Passes |
| Guinea Pig Sensitization | Passes | Passes |
2. Sample Size and Data Provenance for Test Set
The document does not specify the exact sample sizes used for each individual test (Dimensions, Physical Properties, Freedom from pinholes, Powder-Free, Biocompatibility). However, the tests are laboratory-based, adhering to predefined ASTM standards.
- Data Provenance: The data is generated from laboratory testing against established ASTM (American Society for Testing and Materials) standards. This indicates a prospective testing methodology. The country of origin of the data is not explicitly stated, but the submission is to the FDA in the USA.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
This device is not an AI/ML powered device, therefore, the concept of establishing ground truth with experts in the typical sense for image interpretation or diagnosis does not apply. The "ground truth" here refers to the objective measurements and pass/fail criteria defined by the ASTM standards themselves. These standards are developed through a consensus process by experts in the field of materials science and medical devices.
4. Adjudication Method for Test Set
Not applicable. The tests are based on objective measurements and adherence to specific ASTM standard specifications, rather than subjective interpretations requiring adjudication.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an AI/ML powered device, and no MRMC study was performed or required. The device is a physical medical examination glove. Clinical data were explicitly stated as "not needed for examination gloves" [9].
6. Standalone Performance (Algorithm Only)
Not applicable. This is a physical device, not an algorithm.
7. Type of Ground Truth Used (Test Set)
The ground truth for the performance claims is derived from established ASTM standards for medical examination gloves. These standards specify objective physical, chemical, and biological properties that the gloves must meet.
8. Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set for a physical product, the concept of establishing ground truth for a training set does not apply.
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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 3578-99Meets ASTM D 5151 |
| Powder-Free | Meets ASTM D 61244 mg/glove maximum |
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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.
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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
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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
(Division Sign-C and (
(Ar-N, (Roman I-2-30))
§ 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.