(141 days)
A patient examination glove is a medical device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
The powder-free vinyl exam gloves are disposable devices intended to be worn by healthcare and similar personnel to prevent contamination between such personnel and the patient. The powder-free vinyl exam gloves possess the following technological characteristics (as compared to ASTM or equivalent standards): Dimensions, Physical Properties, Freedom from pinholes, Powder Free.
Here's an analysis of the provided information regarding the SAFESKIN* BLUE ZONE Powder-Free Vinyl Exam Glove, structured to address your request:
Acceptance Criteria and Device Performance Study for SAFESKIN BLUE ZONE Powder-Free Vinyl Exam Glove*
This submission details the safety and effectiveness of a powder-free vinyl exam glove, demonstrating its substantial equivalence to a predicate device. The primary method of proving equivalence and meeting acceptance criteria relies on compliance with established ASTM standards for patient examination gloves and ISO standards for biocompatibility.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic / Study Title | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimensions | Meets ASTM D 5250-00 ("Standard Specification for Poly(vinyl chloride) Gloves for Medical Application") | Meets ASTM D 5250-00 |
| Physical Properties | Meets ASTM D 5250-00 | Meets ASTM D 5250-00 |
| Freedom from Pinholes | Meets ASTM D 5250-00 and ASTM D 5151-99 | Meets ASTM D 5250-00Meets ASTM D 5151-99 |
| Powder Free | Meets ASTM D 6124-01 and ASTM D 5250-00 | Meets ASTM D 6124-01Meets ASTM D 5250-00 |
| Biocompatibility: | (ISO 10993, "Biological Evaluation of Medical Devices") | |
| ISO Skin Irritation Study | Part 10, "Tests for Irritation and Sensitization" (Pass/Fail) | Passed (Test Animal: Rabbit) |
| Murine Local Lymph Node Assay (LLNA) | Part 10, "Tests for Irritation and Sensitization" (Pass/Fail) | Passed (Test Animal: Mouse) |
| USP and ISO Systemic Toxicity Study Extract | Part 11, "Tests for Systemic Toxicity(ISO)" (Pass/Fail) | Passed (Test Animal: Mouse) |
2. Sample Size Used for the Test Set and Data Provenance
The provided summary does not explicitly state exact sample sizes for each specific test (e.g., number of gloves tested for dimensions, pinholes, or powder). However, compliance with ASTM standards generally implies specific sampling plans and test methodologies. The data provenance is not explicitly mentioned by country of origin, but the testing was conducted by the Kimberly-Clark Corporation for submission to the US FDA. The studies are prospective in nature, as they are conducted specifically to demonstrate compliance for a new device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This type of medical device (exam glove) does not typically involve human expert interpretation of results in the way, for example, an imaging AI would. The "ground truth" for the acceptance criteria (ASTM and ISO standards) is established by the test methods and objective measurements outlined within those standards. Therefore, no human experts as typically defined in an AI/clinical study context were used to establish the ground truth for the performance test set. Expert committees within ASTM and ISO develop and maintain these standards.
4. Adjudication Method for the Test Set
Not applicable. As described above, the acceptance criteria are based on objective measurements against established technical standards, not on subjective expert consensus requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret data, often with or without AI assistance, to assess diagnostic accuracy or efficiency. For a patient examination glove, the efficacy is determined by its physical properties and biocompatibility, not by human interpretation of its function in a diagnostic context.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone (algorithm-only) performance study was not done. This device is a physical product, not a software algorithm. The performance evaluation is based on direct physical and chemical testing of the glove.
7. The Type of Ground Truth Used
The ground truth used for evaluating the device's performance is established industry standards and objective test methods. Specifically:
- ASTM D 5250-00, ASTM D 5151-99, ASTM D 6124-01: These standards define the acceptable physical and chemical properties of patient examination gloves and provide the test methods to determine compliance.
- ISO 10993 Parts 10 and 11: These international standards define the test methods and acceptable outcomes for biological evaluation (biocompatibility) of medical devices.
8. The Sample Size for the Training Set
Not applicable. This device is a physical product and does not involve a "training set" in the context of machine learning or AI algorithms. The manufacturing process is subject to quality control, but there isn't a training dataset for an algorithm.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for a software algorithm.
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SAFESKIN* BLUE ZONE Powder-Free Vinyl Exam Glove
OCT 2 4 2003
erly-Clark Corporation
FALTH CARE SECTOR 00 Holcomb Bridge Road oswell GA 30076-2199
Phone: (770) 587-8000 Fax: (770) 587-7762
SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
- 510(k) Summary of Safety and Effectiveness Information [1]
- Kimberly-Clark Corporation [2] 1400 Holcomb Bridge Road Roswell, GA 30076-2199 770-587-8000 Telephone: Fax: 770-587-7762
Richard V. Wolfe Contact: Telephone: 770-587-8208 Fax: 770-587-7761
- SAFESKIN* BLUE ZONE Powder-Free Vinyl Exam Glove (3) Trade Name: Common Name: Patient Examination Gloves, Vinyl Classification Name: Patient Examination Gloves, Vinyl
- The predicate device is a Class I, powder-free vinyl exam glove 80L YZ that meets all of the [4] requirements of ASTM D 5250-00, "Standard Specification for Poly(vinyl chloride) Gloves for Medical Application"
- The powder-free vinyl exam glove meets the current specifications of ASTM D 5250-00. [૨] "Standard Specification for Poly(vinyl chloride) Gloves for Medical Application"
- The powder-free vinyl exam gloves are disposable devices intended to be worn by healthcare [6] and similar personnel to prevent contamination between such personnel and the patient.
Attachment H (page 1 of 2)
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SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION (Cont'd)
- The powder-free vinyl exam gloves possess the following technological characteristics (as [7] compared to ASTM or equivalent standards):
| Characteristics | Standards |
|---|---|
| Dimensions | Meets ASTM D 5250-00 |
| Physical Properties | Meets ASTM D 5250-00 |
| Freedom from pinholes | Meets ASTM D 5250-00Meets ASTM D 5151-99 |
| Powder Free | Meets ASTM D 6124-01Meets ASTM D 5250-00 |
Biocompatibility - Biocompatibility testing was conducted to the following parts of ISO 10993, "Biological Evaluation of Medical Devices":
- Part 10, "Tests for Irritation and Sensitization" ●
- Part 11, "Tests for Systemic Toxicity(ISO): ●
| Study Title | Test Animal | Results |
|---|---|---|
| ISO Skin Irritation Study | Rabbit | Passed |
| Murine Local Lymph Node Assay (LLNA) | Mouse | Passed |
| USP and ISO Systemic Toxicity Study Extract | Mouse | Passed |
- [8] The performance test data that support a determination of substantial equivalence are described above.
- ી છે Clinical data are not needed for examination gloves.
- It can be concluded that the powder-free vinyl exam glove is safe and effective and will [10] 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 exam glove is substantially equivalent to currently marketed exam gloves.
Attachment H (page 2 of 2)
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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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human figure, represented by three overlapping profiles, with a wing-like shape above them.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 4 2003
Mr. Richard V. Wolfe Manager, Regulatory Affairs Kimberly-Clark Corporation 1400 Holcomb Bridge Road Roswell, Georgia 30076
Re: K031750
Trade/Device Name: SAFESKIN* BLUE ZONE Powder-Free Vinyl Exam Glove Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: LYZ Product Code: I Dated: August 14, 2003 Received: August 18, 2003
Dear Mr. Wolfe:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 -Mr. Wolfe
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Sina Runne
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/2 description: The image shows the logo of Kimberly-Clark Corporation. The logo consists of a circular symbol with a stylized "KC" inside, followed by the company name "Kimberly-Clark Corporation" in bold, sans-serif font. The logo is simple and professional, reflecting the company's established presence in the consumer goods industry.
HEALTH CARE SECTOR 1400 Holcomb Bridge Road Roswell, GA 30076-2199
Phone: (770) 587-8000 Fax: (770) 587-7762
DICATIONS FOR USE
| Applicant: | Kimberly-Clark Corporation |
|---|---|
| 510(k) Number: | K031750 |
| Device Name: | SAFESKIN* BLUE ZONE Powder-Free Vinyl Exam Glove |
| Indications for Use: | Based upon 21CFR§880.6250 “Patient examination glove”: |
| A patient examination glove is a medical device intended for medical |
A patient examination glove is a medical device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Patrice Ari, Lisen Branch Chief, IMCS 10/23/6
Division Sign-Off) (Division of Anesthesiology, General Hospital, Infection Control, Dental D
510(k) Number: K031752
OR
Prescription Use Per 21CFR 801.109 Over-The-Counter
Attachment C
§ 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.