(81 days)
Not Found
No
The device description and intended use clearly define a standard medical glove, with no mention of AI/ML capabilities or related data/studies.
No
The document states the device is an exam glove intended to prevent contamination, which is a protective function, not a therapeutic one.
No.
The device is described as an exam glove, intended to prevent contamination between patient and examiner, not to diagnose a condition.
No
The device description clearly states it is a physical 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 glove worn on the hand to prevent contamination between patient and examiner. This is a barrier device for physical protection.
- Definition of IVD: An In Vitro Diagnostic device is 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 examination or analysis of biological samples.
- Device Description: The description confirms it's a glove with physical characteristics (material, texture, sterility).
- Lack of IVD-related information: The document does not mention any processes related to analyzing biological samples, image processing, AI/ML for diagnosis, or performance metrics typically associated with diagnostic tests (like sensitivity, specificity, AUC).
This device falls under the category of a medical device, specifically a patient examination glove, as defined by 21CFR§880.6250.
N/A
Intended Use / Indications for Use
The Kimberly-Clark* STERLING Nitrile Powder-Free Exam Glove, Sterile, is a disposable device intended for medical purposes that is 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 (comma separated list FDA assigned to the subject device)
LZA
Device Description
Light gray nitrile, chlorinated, powder-free, sterile, textured fingertip, ambidextrous patient examination glove
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner / 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 Tests:
Dimensions - ASTM D 6319-00a
Physical Properties - ASTM D 6319-00a
Freedom from pinholes - ASTM D 6319-00a, ASTM D 5151-06
Powder Free - ASTM D 6124-06
Sterility - ASTM D 6319-00a, ISO 11137-2
ISO Skin Irritation Study - ISO 10993, Part 10
Murine Local Lymph Node Assay - ISO 10993, Part 10
ISO Systemic Toxicity Study - ISO 10993, Part 11
Clinical Tests:
No new clinical tests were required to support this 510(k) application.
Conclusions:
Non-clinical laboratory and animal based biocompatibility test data confirm the Kimberly-Clark* STERLING* Nitrile Powder-Free Exam Glove, Sterile, meets all applicable performance and biocompatibility requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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.
0
දිවූ Kimberly-Clark Corporation
Abbreviated 510(k) for Kimberly-Clark* Sterile STERLING* Nitrile Powder-Free Exam Glove
Section 5. 510(k) SUMMARY
JUN 3 0 2008
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: | April 9, 2008 |
| Trade Name: | Kimberly-Clark* Sterile STERLING* 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) |
| • Kimberly-Clark* PURPLE NITRILE* Powder-Free Exam Glove, Sterile | |
| (K992062) | |
| Description of the device: | Light gray nitrile, chlorinated, powder-free, sterile, textured fingertip, |
| ambidextrous patient examination glove | |
| Intended use of device: | The Kimberly-Clark* STERLING Nitrile Powder-Free Exam Glove, Sterile, |
| is a disposable device intended for medical purposes that is 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 |
| devices. They are all chlorinated, powder-free nitrile gloves. This specific | |
| glove is gray in color, packaged in pairs in packaging to maintain sterility and | |
| sterilized by gamma irradiation. |
Page 1 of 2 - Section 5 510(k) Summary
1
Image /page/1/Picture/1 description: The image shows the Kimberly-Clark Corporation logo. The logo consists of a circular symbol with a stylized "K" inside, followed by the text "Kimberly-Clark Corporation" in a bold, sans-serif font. The text is aligned horizontally to the right of the symbol.
Abbreviated 510(k) for Kimberly-Clark* Sterile STERLING* Nitrile Powder-Free Exam Glove ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| Brief description of Non-Clinical Tests: | Non-Clinical Tests
Dimensions
Physical Properties
Freedom from pinholes
Powder Free
Sterility
ISO Skin Irritation Study
Murine Local Lymph Node Assay
ISO Systemic Toxicity Study | Standard
ASTM D 6319-00a
ASTM D 6319-00a
ASTM D 6319-00a
ASTM D 5151-06
ASTM D 6124-06
ASTM D 6319-00a
ISO 11137-2
ISO 10993, Part 10
ISO 10993, Part 10
ISO 10993, Part 11 |
|-------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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* STERLING* Nitrile Powder-Free Exam Glove, Sterile, meets all applicable performance and biocompatibility requirements. | |
| Other Information deemed necessary by the FDA: | None | |
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 3 0 2008
Mr. Richard V. Wolfe Associate Director, Regulatory Affairs Kimberly-Clark Corporation 1400 Holcomb Bridge Road Roswell, Georgia 30076
Re: K081027
Trade/Device Name: KIMBERLY-CLARK* Sterile STERLING* Nitrile Powder-Free Exam Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: June 18, 2008 Received: June 20, 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.
3
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 (OS) 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,
signature
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
3 Kimberly-Clark Corporation
INDICATIONS FOR USE
Kimberly-Clark Corporation Applicant:
510(k) Number:
Device Name:
KIMBERLY-CLARK* Sterile STERLING* Nitrile Powder-Free Exam Glove
Indications for Based upon 21CFR§880.6250 "Patient examination glove" 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
Per 21CFR 801.109 Subpart C X |
| ------------------------------------------------- | ---- | ---------------------------------------------------------------------------------------------------- |
|---|
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
| 510(k) Number: | K081027 |
|---|---|
| ---------------- | --------- |