(66 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 and for use with chemotherapeutic agents.
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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Safeskin Purple Nitrile Examination Gloves:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Standards / Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dimensions | Meets ASTM D 6319-99 | Meets ASTM D 6319-99 |
| Physical Properties | Meets ASTM D 6319-99 | Meets ASTM D 6319-99 |
| Freedom from pinholes | Meets ASTM D 6319-99Meets ASTM D 5151 | Meets ASTM D 6319-99Meets ASTM D 5151 |
| Powder-Free | Meets ASTM D 61242 mg/glove maximum | Meets ASTM D 61242 mg/glove maximum |
| Biocompatibility | Primary Skin Irritation in Rabbits | Passes |
| Guinea Pig Sensitization | Passes | |
| Chemotherapeutic Agent Permeation | ASTM F 739-96 | Passes ASTM F 739-96 |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for the testing, nor does it detail the provenance (e.g., country of origin, retrospective/prospective) of the data for each test. The testing is implied to be for product validation against ASTM standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish a "ground truth" for the test set in the way one might for diagnostic algorithm performance. The device's performance is assessed against established ASTM standards, which themselves are developed by expert consensus in their respective fields but not as part of this device-specific submission.
4. Adjudication Method for the Test Set
Not applicable. The "adjudication method" typically refers to how discrepancies in expert opinions are resolved to establish ground truth for a diagnostic study. Here, the device is evaluated against predefined, objective ASTM standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI assistance on human reader performance, which is not applicable to a device like examination gloves. The device is a standalone product.
6. Standalone Performance Study
Yes, a standalone performance study was done. The entire submission details the performance of the Safeskin Purple Nitrile Examination Glove itself against established industry (ASTM) and internal standards without human intervention influencing the device's function. The results indicate that the device "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."
7. Type of Ground Truth Used
The "ground truth" used for this device's evaluation is primarily based on established industry standards (ASTM) for physical properties, dimensions, freedom from pinholes, powder content, biocompatibility, and chemotherapeutic agent permeation. There is no mention of pathology, expert consensus (in the context of clinical reads), or outcomes data as the primary ground truth for these product characteristics.
8. Sample Size for the Training Set
Not applicable. The concept of a "training set" is relevant for machine learning algorithms. This submission is for a physical medical device (examination gloves) and does not involve AI or machine learning models that require training data. The "training data" here would metaphorically be the experience and research that went into the glove's design, but not in the computational sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of an AI/ML algorithm.
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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 6319-99Meets ASTM D 5151 |
| Powder-Free | Meets ASTM D 61242 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
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.