(14 days)
80LZA
Not Found
No
The device description and performance studies focus on the physical and material properties of examination gloves, with no mention of AI or ML.
No
The device, a patient examination glove, is intended to prevent contamination between patient and examiner, which is a preventive measure rather than a therapeutic treatment for a disease or condition.
No
Explanation: The device, powder-free nitrile exam gloves, is described as preventing contamination between patient and examiner. There is no mention of it being used for diagnosis, disease detection, or any form of medical assessment. Its function is protective, not diagnostic.
No
The device description clearly states it is a physical product (powder-free nitrile exam gloves) and details its physical properties and testing. There is no mention of software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "patient examination glove" worn on the hand to prevent contamination between patient and examiner. This is a barrier device for personal protection and infection control.
- Device Description: The description reinforces this by stating the gloves are "disposable devices intended to be worn by healthcare and similar personnel to prevent contamination between such personnel and the patient."
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. IVDs are used in vitro (outside the body) to analyze biological samples.
- Regulatory Classification: The reference to 21CFR§880.6250 "Patient examination glove" places this device within a category of general hospital and personal use devices, not IVDs.
Therefore, the device described is a medical device, but specifically a patient examination glove, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes
LZA
Device Description
The powder-free nitrile 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 nitrile exam gloves possess the following technological characteristics (as compared to ASTM or equivalent standards): Dimensions Meets ASTM D 6319 Physical Properties Meets ASTM D 6319 Freedom from pinholes Meets ASTM D 6319 Meets ASTM D 5151 Powder Free Meets ASTM D 6124 Meets ASTM D 6319
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 |
The performance test data that support a determination of substantial equivalence are described above.
Clinical data are not needed for examination gloves.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
SAFESKIN* PURPLE NITRILE* Powder-Free Exam Glove, 80LZA
Reference Device(s)
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).
Not Found
§ 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 logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The logo is surrounded by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 5 2005
Mr. Richard V. Wolfe Manager, Regulatory Affairs Kimberly-Clark Corporation 1400 Holcomb Bridge Road Roswell, Georgia 30076-2199
Re: K051347
Trade/Device Name: Kimberly-Clark* Sterling* Nitrile Powder-Free Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA Dated: May 23, 2005 Received: May 24, 2005
Dear Mr. Wolfe:
This letter corrects our substantially equivalent letter of June 7, 2005, for the device name.
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 (240) 276-0115. 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/industry/support/index.html.
Sincerely vours.
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/2/Picture/1 description: The image shows a circular emblem with a stylized cross-like symbol at its center. The symbol is composed of geometric shapes, resembling a combination of arrows and stylized letters. The emblem is black and white, with a thick black outline defining the circular shape and the inner symbol.
Kimberly-Clark Corporation
HEALTH CARE SECTOR 1400 Holcomb Bridge Road Roswell, 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
- [2] Kimberly-Clark Corporation 1400 Holcomb Bridge Road Roswell, GA 30076-2199 Telephone: 770-587-8000 Fax: 770-587-7762 Contact: Richard V. Wolfe Telephone: 770-587-8208 Fax: 770-587-7761 [3] Trade Name: KIMBERLY-CLARK* STERLING* Nitrile Powder-Free Exam Glove Common Name: Patient Examination Gloves, Nitrile Classification Name: Patient Examination Gloves, Nitrile [4] The predicate device is a Class I, SAFESKIN* PURPLE NITRILE* Powder-Free Exam
- Glove, 80LZA, that meets all of the requirements of ASTM D 6319, "Standard Specification for Nitrile Examination Gloves for Medical Application".
- [૨] The powder-free nitrile exam glove meets the current specifications of ASTM D 6319, "Standard Specification for Nitrile Examination Gloves for Medical Application".
- [6] The powder-free nitrile 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 nitrile exam gloves possess the following technological characteristics [7] (as compared to ASTM or equivalent standards):
| Characteristics | Standards |
|---|---|
| Dimensions | Meets ASTM D 6319 |
| Physical Properties | Meets ASTM D 6319 |
| Freedom from pinholes | Meets ASTM D 6319 |
| Meets ASTM D 5151 | |
| Powder Free | Meets ASTM D 6124 |
| Meets ASTM D 6319 |
Attachment H (page 1 of 2)
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Image /page/3/Picture/0 description: The image shows a white symbol inside of a circle. The symbol is a cross with four stylized shapes that look like the letter 'K' surrounding it. The symbol is simple and geometric. The image is black and white.
Kimberly-Clark Corporation
HEALTH CARE SECTOR 1400 Holcomb Bridge Road Roswell, GA 30076-2199
Phone: (770) 587-8000 Fax: (770) 587-7762
SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION (Cont'd)
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 |
- The performance test data that support a determination of substantial equivalence are [8] described above.
- [9] Clinical data are not needed for examination gloves.
- It can be concluded that the powder-free nitrile 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/4/Picture/0 description: The image shows the logo of Kimberly-Clark Corporation. The logo consists of a circular symbol with a cross inside, followed by the company name in bold, black letters. Below the company name, the words "HEALTH CARE SECTOR" are printed in smaller letters.
HEALTH CARE SECTOR 1400 Holcomb Bridge Road Roswell, GA 30076-2199
Phone: (770) 587-8000 Fax: (770) 587-7762
INDICATIONS FOR USE
Kimberly-Clark Corporation Applicant:
510(k) Number:
KIMBERLY-CLARK* STERLING* Nitrile Powder-Free Latex Exam Device Name: Glove
Indications for Use: Based upon 21CFR§880.6250 "Patient examination glove":
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)
Shule H. Murphy 6/4/2
Division of Anesthesiology, General Ho 510(k) Number
| Prescription Use | |
|---|---|
| Per 21CFR 801.109 |
Over-The-Counter
Attachment C
OR