(83 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.
The powder-free latex exam glove with vitamin E and aloe meets the current specifications for ASTM D 3578-00a. The powder-free latex exam gloves with vitamin E and aloe are disposable devices intended to be worn by healthcare and similar personnel to prevent contamination between such personnel and the patient.
The provided document is a 510(k) summary for a medical device, specifically the "SAFESKIN HEALTHTOUCH" Powder-Free Latex Exam Glove with Vitamin E and Aloe. It outlines the device's characteristics and its equivalence to a predicate device, as well as the FDA's approval.
Here's an analysis of the acceptance criteria and the "study" that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Characteristics | Acceptance Criteria (Standards) | Reported Device Performance | Comments |
|---|---|---|---|
| Dimensions | Meets ASTM D 3578-00a | Meets ASTM D 3578-00a | Confirmed |
| Physical Properties | Meets ASTM D 3578-00a | Meets ASTM D 3578-00a | Confirmed |
| Freedom from pinholes | Meets ASTM D 3578-00a | Meets ASTM D 3578-00a | Confirmed |
| Meets ASTM D 5151-99 | Meets ASTM D 5151-99 | Confirmed | |
| Powder Free | Meets ASTM D 6124-00a | Meets ASTM D 6124-00a | Confirmed |
| Meets ASTM D 3578-00a | Meets ASTM D 3578-00a | Confirmed | |
| Protein Content | Meets ASTM D 5712-99 (< 50 µg/g) | < 50 µg/g | Confirmed, specifically states "< 50 µg/g" |
| Primary Skin Irritation | Passed (in Rabbits) | Passed | Confirmed |
| Guinea Pig Sensitization | Passed | Passed | Confirmed |
2. Sample size used for the test set and the data provenance
The document does not specify sample sizes for individual tests (e.g., how many gloves were tested for pinholes, or how many animals were used for biocompatibility). It only states that the "performance test data... are described above" [8].
Data provenance is not explicitly mentioned as country of origin, nor whether the data is retrospective or prospective. It is implied to be data collected to support this specific 510(k) application.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this type of device and study. This is a medical glove, and its performance is evaluated against standardized physical and chemical tests (ASTM standards) and biocompatibility tests, not against expert human interpretation of medical images or patient outcomes. The "ground truth" is defined by the objective pass/fail criteria of the ASTM standards and biocompatibility tests.
4. Adjudication method for the test set
This is not applicable. The evaluation of exam glove performance against ASTM standards and biocompatibility tests does not involve human adjudication in the way medical image analysis or clinical trials might. The results are objective measurements against defined criteria.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. This document is for a physical medical device (exam gloves), not an AI-powered diagnostic or decision support system. Therefore, no MRMC study or AI-related comparative effectiveness analysis was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. As mentioned above, this is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by objective, standardized measurements and tests against the specific ASTM standards listed (e.g., ASTM D 3578-00a, ASTM D 5151-99, ASTM D 6124-00a, ASTM D 5712-99) and common biocompatibility testing protocols (Primary Skin Irritation in Rabbits, Guinea Pig Sensitization). These standards define what constitutes acceptable performance for dimensions, physical properties, freedom from pinholes, powder content, protein content, and lack of adverse biological reactions.
8. The sample size for the training set
This is not applicable. This is not a machine learning or AI device, so there is no concept of a "training set" in the context of this 510(k) submission.
9. How the ground truth for the training set was established
This is not applicable for the same reasons as #8.
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Image /page/0/Picture/0 description: The image shows the Kimberly-Clark logo. The logo consists of a stylized "K" inside a circle on the left, followed by the words "Kimberly-Clark" in bold, sans-serif font. The logo is black and white.
NOV 1 3 2001
August 21, 2001
- [1] 510(k) Summary of Safety and Effectiveness Information
[2] Kimberly-Clark Corporation 1400 Holcomb Bridge Road Roswell, GA 30076-2199 Telephone: 770-587-8000 770-587-7762 Fax:
Contact: Marcia Johnson Telephone: 770-587-8324 Fax: 770-587-7762
- "SAFESKIN HEALTHTOUCH" Powder-Free Latex Exam Glove [3] Trade Name: with Vitamin E and Aloe Patient Examination Gloves, Latex Common Name: Classification Name: Patient Examination Gloves, Latex
- [4] The predicate device is a Class I, powder-free latex exam glove 80L Y Y that meets all of the requirements of ASTM D 3578-00a, Standard Specification for Rubber Examination Gloves.
- The powder-free latex exam glove with vitamin E and aloe meets the current [૨] specifications for ASTM D 3578-00a.
- [୧] The powder-free latex exam gloves with vitamin E and aloe are disposable devices intended to be worn by healthcare and similar personnel to prevent contamination between such personnel and the patient.
- [7] The powder-free latex exam gloves with vitamin E and aloe possess the following technological characteristics (as compared to ASTM or equivalent standards):
| Characteristics | Standards |
|---|---|
| Dimensions | Meets ASTM D 3578-00a |
| Physical Properties | Meets ASTM D 3578-00a |
| Freedom from pinholes | Meets ASTM D 3578-00a |
| Meets ASTM D 5151-99 | |
| Powder Free | Meets ASTM D 6124-00a |
| Meets ASTM D 3578-00a |
G2
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Image /page/1/Picture/0 description: The image shows the Kimberly-Clark logo. The logo consists of a stylized symbol on the left, followed by the company name "Kimberly-Clark" in bold, sans-serif font. The symbol appears to be a stylized cross or geometric shape enclosed within a circle.
Protein Content
Meets ASTM D 5712-99 < 50 µg/g
Biocompatability
| Primary Skin Irritation in Rabbits | Passed |
|---|---|
| Guinea Pig Sensitization | Passed |
- The performance test data that support a determination of substantial equivalence are [8] described above.
- Clinical data are not needed for examination gloves. િત
- It can be concluded that the powder-free latex exam glove with vitamin E and aloe is safe [10] It can be ocheluded that the porccording to the glove performance standards referenced in and chool.vo and will perfected ing ASTM standards, FDA requirements, and the labeling claims for the product. Consequently, this exam glove is substantially equivalent to currently marketed exam gloves.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 3 2001
Ms. Marcia Jonhson Senior Regulatory Associate Kimberly-Clark Corporation 1400 Holcomb Bridge Road Roswell, Georgia 30076
Re: K012815
R012815
Trade/Device Name: Safeskin Healthtouch Powder-Free Examination Glove with Vitamin E, Aloe and Protein Content Labeling Claim (50 Micrograms or Less) Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: August 21, 2001 Received: August 22, 2001
Dear Ms. Johnson:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becater mined 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 Interstate commerce prior to that have been reclassified in accordance with the provisions of Antinunients, or to do roug, and Cosmetic Act (Act) that do not require approval of a premarket the Fouchal I ood, Drag, and Commons, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls providents or 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 If your device is classinod (see as additional controls. Existing major regulations affecting (FMA), it may of subject to back adding the end Regulations, Title 21, Parts 800 to 898. In your device can or rouncements concerning your device in the Federal Register.
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
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Page 2 - Ms. Johnson
of the Act or any Federal statutes and regulations administered by other Federal agencies. of the Act of ally I oderal bats requirements, including, but not limited to: registration Touring (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice alle listing (21 OF RT rat 807), abolity 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 310(K) prematics notification. 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 If you desire specific ad not 10. Jour in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and office of configurar device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and alle Act may of ocument 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 yours,
Ti hy A. Ulatowski 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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NOV 1 3 2001
INDICATIONS FOR USE
| Applicant: | Kimberly-Clark Corporation |
|---|---|
| 510(k) Number: | K012815 |
| Device Names: | SAFESKIN HEALTHTOUCH Powder-Free Latex Exam Glovewith Vitamin E and Aloe with Protein Labeling Claim( 50 MICROGRAMS OR LES |
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Over-The-Counter _____________________________________________________________________________________________________________________________________________________________
Olin S. Lin
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Device B2 510(k) Number .
§ 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.