(66 days)
Not Found
Not Found
No
The 510(k) summary describes a standard medical glove and does not mention any AI or ML capabilities.
No.
The device description clearly states its purpose is to prevent contamination between personnel and patients and for use with chemotherapeutic agents, not to treat a medical condition or disease. It functions as a barrier, a prophylactic measure, rather than an active therapeutic intervention.
No
Explanation: The device is an examination glove, used to prevent contamination, not to diagnose a condition or disease.
No
The device is a physical glove, not software. The description clearly states it is a "medical glove" and a "disposable device intended to be worn".
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to diagnose, monitor, or screen for health issues.
- Device Function: The device described is a medical glove. Its function is to provide a physical barrier to prevent contamination between healthcare personnel and patients, and to offer protection when handling chemotherapeutic agents.
- Lack of Diagnostic Function: The glove does not perform any test on a biological sample to provide diagnostic information. It is a protective barrier, not a diagnostic tool.
The information provided clearly describes a protective medical device, not an in vitro diagnostic test.
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 and for use with chemotherapeutic agents.
Product codes (comma separated list FDA assigned to the subject device)
LZC
Device Description
Safeskin Purple Nitrile Examination Gloves are disposable devices 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
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Input Imaging Modality
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Anatomical Site
hands
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance test data described in item 7:
| Characteristics | Standards |
|---|---|
| Dimensions | Meets ASTM D 6319-99 |
| Physical Properties | Meets ASTM D 6319-99 |
| Freedom from pinholes | Meets ASTM D 6319-99, Meets ASTM D 5151 |
| Powder-Free | Meets ASTM D 6124, 2 mg/glove maximum |
Biocompatability testing:
Primary Skin Irritation in Rabbits - Passes
Guinea Pig Sensitization - Passes
Permeation Testing with Chemotherapeutic Agents - Passes ASTM F 739-96
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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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Image /page/0/Picture/1 description: The image shows the text "K992162 Safeskin Corporation". The text appears to be handwritten, with the "K992162" portion in a cursive style. Below the numbers, the words "Safeskin Corporation" are printed in a smaller, sans-serif font.
June 24, 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: Fax: 619-350-2382
| Contact: | Eugene V. Goorchenko |
|---|---|
| Telephone: | 619-509-7010 |
| Fax: | 619-350-2382 |
- [3] Trade Name: Safeskin Purple Nitrile Examination Gloves Common Name: Patient Examination Gloves Classification Name: Patient Examination Gloves
- [4] The predicate is a Safeskin blue Nitrile Examination Glove which meets all of the requirements of ASTM D 6319-99, Standard Specification for Nitrile Examination Gloves for Medical Application.
- [ર] The Safeskin Purple Nitrile Examination Glove will meet all the current specifications for ASTM D 6319-99.
- [୧] Safeskin Purple Nitrile Examination Gloves are disposable devices 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] Safeskin Purple Nitrile Examination Gloves possess the following technological characteristics (as compared to ASTM or equivalent standards):
| Characteristics | Standards |
|---|---|
| Dimensions | Meets ASTM D 6319-99 |
| Physical Properties | Meets ASTM D 6319-99 |
| Freedom from pinholes | Meets ASTM D 6319-99 |
| Meets ASTM D 5151 | |
| Powder-Free | Meets ASTM D 6124 |
| 2 mg/glove maximum |
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Image /page/1/Picture/1 description: The image shows the text "K992162" in a handwritten style. Below this, the words "Safeskin Corporation" are printed in a clear, legible font. The text is black against a white background, creating a high contrast image.
Biocompatability
| Primary Skin Irritation in Rabbits | Passes | |
|---|---|---|
| Guinea Pig Sensitization | Passes | |
| Permeation Testing with | ||
| Chemotherapeutic Agents | Passes ASTM F 739-96 | |
| [8] | The performance test data that support a determination of substantial equivalence |
- [[]] are described above.
- (તે) Clinical data are not needed for examination gloves.
- It can be concluded that the Safeskin Purple Nitrile Examination Glove in safe and [10] 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 seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of three stylized human profiles facing right, with a stylized bird above them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 30 1999
Mr. Eugene V. Goorchenko Director of Regulatory Affairs Safeskin Corporation 12671 High Bluff Drive San Diego, California 92130
K992162 Re : Safeskin Purple Powder-Free Nitrile Trade Name: Examination Gloves For Use With Chemotherapeutic Drugs Labeling Claim Regulatory Class: I Product Code: LZC Dated: June 24, 1999 Received: June 25, 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 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 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) requlation (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.
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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 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 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
Timothy 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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FDA 510(k), Premarket Notification
Safeskin Corporation
INDICATIONS FOR USE
Applicant:
Safeskin Corporation
510(k) Number:
Device Name:
Purple Nitrile Patient Examination Glove for use with Chemotherapeutic Agents
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 and for use with chemotherapeutic agents.
Baud by Clin
of Dental, Infection Control, eneral Hospit i O{k} Number
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Over-The-Counter
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