(89 days)
Not Found
No
The device description and intended use clearly define it as a standard patient examination glove, with no mention of AI or ML capabilities. The performance studies focus on biocompatibility and meeting ASTM standards, not algorithmic performance.
No.
Explanation: The device, a patient examination glove, is intended for preventing contamination between patient and examiner, which is a protective function, not a therapeutic one that treats or rehabilitates a medical condition.
No
The device is a patient examination glove, which is intended to prevent contamination between patient and examiner. It does not perform any diagnostic function.
No
The device description clearly states it is a physical glove made of nitrile, which is a hardware component. The summary also details performance studies related to the physical properties and biocompatibility of the glove.
No, 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 physical barrier device used for protection during medical examinations.
- Definition of IVD: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases, conditions, or infections. This device does not perform any such testing.
- Device Description: The description details the physical characteristics of the glove and its compliance with a standard for examination gloves. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD-related information: The document does not contain any information typically associated with IVDs, such as:
- Analysis of biological samples
- Detection of analytes
- Performance metrics like sensitivity, specificity, or AUC related to diagnostic testing
- Training or test sets for diagnostic algorithms
The device is a Class I medical device (as indicated by the predicate devices being examination gloves) used for barrier protection, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Kimberly-Clark* STERLING* Nitrile and Nitrile-Xtra* 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.
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.
Product codes
LZC
Device Description
Light gray 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
Hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Examiner (for medical purposes)
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 - Meets
- Physical Properties: ASTM D 6319-00a - Meets
- Freedom from pinholes: ASTM D 6319-00a, ASTM D 5151-06 - Meets
- Powder Free: ASTM D 6124-06, 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
- Resistance to Permeation (Protective Clothing): ASTM F 739-07 - See data below
- Resistance to Permeation (Medical Gloves): ASTM D 6978-05 - See data below
Tested Chemotherapy Drug and Concentration (Average Breakthrough Detection Time):
- Cyclophosphamide (20.0 mg/ml): No breakthrough up to 240 minutes
- Doxorubicin HCI (2.0 mg/ml): No breakthrough up to 240 minutes
- Etoposide (20.0 mg/ml): No breakthrough up to 240 minutes
- 5-Fluorouracil (50.0 mg/ml): No breakthrough up to 240 minutes
- Paclitaxel (Taxol) 6.0 mg/ml): No breakthrough up to 240 minutes
- ThioTEPA (10.0 mg/ml): Avg. minutes before breakthrough = 54.2
- Cisplatin (1.0 mg/ml): No breakthrough up to 240 minutes
- Dacarbazine (10.0 mg/ml): No breakthrough up to 240 minutes
- Ifosfamide (50.0 mg/ml): No breakthrough up to 240 minutes
- Mitoxantrone (2.0 mg/ml): No breakthrough up to 240 minutes
- Vincristine sulfate (1.0 mg/ml): No breakthrough up to 240 minutes
Conclusions: Non-clinical laboratory and animal based biocompatibility test data confirm the Kimberly-Clark* STERLING* Nitrile and Nitrile-Xtra* Powder-Free Exam Gloves Kimberly-Clark* STERLING* meets all applicable 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
Image /page/0/Picture/0 description: The image shows a handwritten string of characters. The characters appear to be a mix of letters and numbers, possibly forming a code or a sequence. The writing style is cursive, with some characters connected to each other.
Image /page/0/Picture/1 description: The image shows the logo for Kimberly-Clark Corporation. 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 black, and the circular symbol is also black.
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Traditional 510(k) for Kimberly-Clark* STERLING* Nitrile & STERLING* Nitrile-Xtra* Powder-Free Exam Gloves with a Chemotherapy Drug Use Claim
Section 5. 510(k) SUMMARY
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: | July 10, 2008 |
| Name of Device | |
| Trade Name: | |
| Common Name: | |
| Classification Name: | Glove, Patient Examination, Specialty - 80 LZC |
| Legally marketed device | |
| to which equivalency is | |
| claimed: | Kimberly-Clark* STERLING* Nitrile Powder-Free Exam Glove - K051347 Perusahaan Getah Asas Sdn. Bhd. Powdered Free Patient Examination |
| Gloves, Blue Colored Non-Sterile (Low Dermatitus Potential and | |
| Chemotherapy Drug Protection Labeling Claims) - K042805 | |
| Description of the device: | Light gray 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* STERLING* Nitrile and Nitrile-Xtra* 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. |
1
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------:
Traditional 510(k) for Kimberly-Clark* STERLING* Nitrile & STERLING* Nitrile-Xtra* Powder-Free Exam Gloves with a Chemotherapy Drug Use Claim
| Summary of technological
characteristics compared
to predicate device: | There are no different technological characteristics compared to the predicate
devices. They are all powder-free non-sterile nitrile exam gloves, one predicate
a gray color and the other a blue color. The Chemotherapy Drug Use Claim is
similar to that of Perusahaan Getah Asas Sdn. Bhd. Powdered Free Patient
Examination Gloves, Blue Colored Non-Sterile (Low Dermatitis Potential and
Chemotherapy Drug Protection Labeling Claims) - K042805 | | |
|------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|----------------|
| 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
ASTM D 5151-06 | Meets |
| | Powder Free | ASTM D 6124-06
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 |
| | Resistance to Permeation
(Protective Clothing) | ASTM F 739-07 | See data below |
| | Resistance to Permeation
(Medical Gloves) | ASTM D 6978-05 | See data below |
| | Tested Chemotherapy Drug and
Concentration | Average Breakthrough Detection Time
(minutes) | |
| | Cyclophosphamide (20.0 mg/ml) | No breakthrough up to 240 minutes | |
| | Doxorubicin HCI (2.0 mg/ml) | No breakthrough up to 240 minutes | |
| | Etoposide (20.0 mg/ml) | No breakthrough up to 240 minutes | |
| | 5-Fluorouracil (50.0 mg/ml) | No breakthrough up to 240 minutes | |
| | Paclitaxel (Taxol) 6.0 mg/ml) | No breakthrough up to 240 minutes | |
| | ThioTEPA (10.0 mg/ml) | Avg. minutes before breakthrough = 54.2 | |
| | Cisplatin (1.0 mg/ml) | No breakthrough up to 240 minutes | |
| | Dacarbazine (10.0 mg/ml) | No breakthrough up to 240 minutes | |
| | Ifosfamide (50.0 mg/ml) | No breakthrough up to 240 minutes | |
| | Mitoxantrone (2.0 mg/ml) | No breakthrough up to 240 minutes | |
| | Vincristine sulfate (1.0 mg/ml) | No breakthrough up to 240 minutes | |
| 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 and Nitrile-Xtra* Powder-Free
Exam Gloves Kimberly-Clark* STERLING* meets all applicable performance
and biocompatibility requirements. | | |
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird-like figure with stylized wings.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 4 2008
Mr. Richard V. Wolfe Associate Director, Regulatory Affairs Kimberly-Clark Corporation 1400 Holcomb Bridge Road Roswell, Georgia 30076
Re: K081089
Trade/Device Name: Kimberly-Clark* STERLING* Nitrile and STERLING* Nitrile-Xtra* Powder-Free Exam Gloves with a Chemotherapy Drug Use Claim Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZC Dated: June 27, 2008 Received: July 2, 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-{See Below For Phone Numbers]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
. Sincerely yours,
Anthony D. Watson for
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
- Applicant: Kimberly-Clark Corporation 510(k) Number: K081089 Kimberly-Clark* STERLING* Nitrile and STERLING* Nitrile-Device Name: Xtra* Powder-Free Exam Gloves with a Chemotherapy Drug Use Claim 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 Over-The-Counter Per 21CFR 801.109 Subpart C
×
Tula N. Murphy, L.S.
OR
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K811899