(68 days)
Not Found
No
The device description and intended use clearly define a standard patient examination glove, with no mention of AI or ML capabilities. The performance studies focus on biocompatibility and standard glove requirements.
No
The device, a patient examination glove, is intended to prevent contamination between the patient and examiner, which is a barrier function rather than a therapeutic one. It does not actively treat or alleviate a medical condition.
No
Explanation: The device is a patient examination glove used to prevent contamination between the patient and examiner, not to diagnose a medical condition. Its intended use is described as preventing contamination, and there is no mention of diagnostic capabilities or outputs.
No
The device description clearly states it is a physical patient examination glove made of nitrile, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "patient examination glove... worn on the examiner's hand to prevent contamination between patient and examiner." This describes a physical barrier device used for protection during examination.
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This glove does not perform any such analysis.
- Device Description: The description focuses on the physical characteristics of the glove (material, color, texture, standards met).
- Lack of IVD-related information: There is no mention of analyzing samples, reagents, or any other components typically associated with IVD devices.
This device is a Class I medical device (specifically, a patient examination glove) used for barrier protection.
N/A
Intended Use / Indications for Use
The Kimberly-Clark* Lavender* Powder-Free Exam Gloves are disposable Devices, intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner.
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
Lavender colored nitrile, chlorinated, powder-free, textured fingertip, ambidextrous patient examination glove that meets all of the requirements of ASTM D 6319-00a, Standard Specification for Nitrile Examination Gloves for Medical Application.
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
Not Found
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)
Non-clinical laboratory and animal based biocompatibility test data confirm the Kimberly-Clark* Lavender* Nitrile Powder-Free Exam Gloves meet all applicable exam glove performance and biocompatibility requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
්රිග් Kimberly-Clark Corporation
Traditional 510(k) for Kimberly-Clark* Lavender* Nitrile Powder-Free Exam Gloves
Section 5. 510(k) SUMMARY
Image /page/0/Picture/4 description: The image shows a sequence of handwritten characters, seemingly a combination of letters and numbers. The sequence starts with the letter 'K', followed by '08', then '1260'. The characters are written in a cursive style, with some connections between them.
SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
| Submitter's Name: | Kimberly-Clark Corporation |
|---|---|
| Submitter's Address: | 1400 Holcomb Bridge Road |
| Roswell, GA 30076-2199 | |
| Submitter's Phone No: | 770-587-8208 |
| Submitter's Fax No. | 920-969-5160 |
| Date of Preparation: | May 1, 2008 |
| Name of Device | |
| Trade Name: | Kimberly-Clark* Lavender* Nitrile Powder-Free Exam Glove |
| Common Name: | Patient examination glove |
| Classification Name: | Glove, Patient Examination, Poly - 80 LZA |
| Legally marketed device | |
| to which equivalency is | |
| claimed: | Kimberly-Clark* STERLING* Nitrile Powder-Free Exam Glove - K051347 |
| Description of the device: | Lavender colored nitrile, chlorinated, powder-free, textured fingertip, |
| ambidextrous patient examination glove that meets all of the requirements of | |
| ASTM D 6319-00a, Standard Specification for Nitrile Examination Gloves for | |
| Medical Application. | |
| Intended use of device: | The Kimberly-Clark* Lavender* Powder-Free Exam Gloves are disposable |
| Devices, intended for medical purposes that are worn on the examiner's hand | |
| to prevent contamination between patient and examiner. | |
| Summary of technological | |
| characteristics compared | |
| to predicate device: | There are no different technological characteristics compared to the predicate |
| device. They are both powder-free non-sterile nitrile exam gloves, the predicate | |
| being a light gray color and the subject of this application being a lavender color. |
1
Traditional 510(k) for Kimberly-Clark* Lavender* Nitrile Powder-Free Exam Gloves
SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
(Continued)
| Brief description of Non-
| Clinical Tests: | Non-Clinical Tests | Standard | Performance |
|---|---|---|---|
| Dimensions | ASTM D 6319-00a | Meets | |
| Physical Properties | ASTM D 6319-00a | Meets | |
| Freedom from pinholes | ASTM D 6319-00a | Meets | |
| ASTM D 5151-06 | Meets | ||
| Powder Free | ASTM D 6124-06 | Meets | |
| ASTM D 6319-00a | Meets | ||
| ISO Skin Irritation Study | ISO 10993, Part 10 | Meets | |
| Murine Local Lymph Node Assay | ISO 10993, Part 10 | Meets | |
| ISO Systemic Toxicity Study | ISO 10993, Part 11 | Meets | |
| Brief description of Clinical | |||
| Tests: | No new clinical tests were required to support this 510(k) application. | ||
| Conclusions drawn from the | |||
| Non-Clinical and Clinical | |||
| Tests: | Non-clinical laboratory and animal based biocompatibility test data confirm | ||
| the Kimberly-Clark* Lavender* Nitrile Powder-Free Exam Gloves meet all | |||
| applicable exam glove performance and biocompatibility requirements. | |||
| Other Information deemed | |||
| necessary by the FDA: | None |
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized eagle with three stripes forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Richard V. Wolfe Associate Director, Regulatory Affairs Kimberly-Clark Corporation 1400 Holcomb Bridge Road Roswell, Georgia 30076
Re: K081260
Trade/Device Name: Kimberly-Clark* Lavender* Nitrile Powder-Free Exam Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: June 16, 2008 Received: June 18, 2008
JUL - 9 2008
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 yours,
Clues
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
4
Kimberly-Clark Corporation
INDICATIONS FOR USE
Kimberly-Clark Corporation Applicant:
K081260 510(k) Number:
Device Name: Kimberly-Clark* Lavender* Nitrile Powder-Free Exam Gloves
Based upon 21 CFR§880.6250 "Patient examination glove" 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Prescription Use Per 21CFR 801.109 Subpart D OR
Over-The-Counter X Per 21CFR 801.109 Subpart C
Clus ts
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K081260