(109 days)
Not Found
No
The device is a physical examination glove and the description focuses on its material properties and resistance to chemicals, with no mention of software, algorithms, or data processing.
No
The device is described as a "patient examination glove" intended to "prevent contamination between patient and examiner," which is a barrier device for protection, not one that provides therapy or treats a condition.
No
The device is a patient examination glove, intended to prevent contamination between patient and examiner and offer protection against chemotherapy drugs. It does not perform any diagnostic function.
No
The device described is a physical examination glove made of nitrile, not a software application.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: An In Vitro Diagnostic device is a medical device that is used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
- Intended Use of the Device: The intended use of this device is clearly stated as a "powder-free patient examination glove... worn on the examiner's hand or finger to prevent contamination between patient and examiner." This is a barrier device used for protection during physical examination or handling.
- Lack of Diagnostic Function: The device does not perform any tests on patient samples to diagnose or detect any condition. Its function is purely protective.
- Chemotherapy Drug Testing: While the gloves are tested for resistance to chemotherapy drugs, this testing is related to the glove's barrier properties and safety for the user when handling these substances. It is not a diagnostic test performed on a patient sample.
Therefore, based on the provided information, this device falls under the category of a general medical device (specifically, a patient examination glove) and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Kimberly-Clark PURPLE NITRILE-XTRA* Powder-Free Exam Glove With Tes Te d FOR USE WITH OFFEMOTHERAPY DRUGS LABELING CLAIM - 12" Length: A powder-free 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. In addition, these chemotherapy gloves were tested for use with the following drug concentrations per ASTM D6978-05: Bleomycin sulfate (15 mg/ml), Busulfan (6 mg/ml), Carboplatin (10 mg/ml), Cisplatin (1.0 mg/ml), Cyclophosphamide (20.0 mg/ml), Cytarabine HCl (100 mg/ml), Dacarbazine (10 mg/ml), Daunorubicin HCl (5.0 mg/ml), Docetaxel (10.0 mg/ml), Doxorubicin HCl (2.0 mg/ml), Epirubicin (Ellence) (2 mg/ml), Etoposide (20.0 mg/ml), Fludarabine (25 mg/ml), Fluorouracil (50.0 mg/ml), Gemcitabine HCl (38.0mg/ml), Idarubicin HCl (1.0mg/ml), Ifosfamide (50.0 mg/ml), Irinotecan HCl (20.0 mg/ml), Mechlorethamine HCl (1.0 mg/ml), Melphalan (5 mg/ml), Methotrexate (25 mg/ml), Mitomycin-C (0.5 mg/ml), Mitoxantrone (2.0 mg/ml), Paclitaxel (6.0 mg/ml), Rituximab (10 mg/ml), ThioTEPA (10.0 mg/ml), Trisenox (0.1 mg/ml), Vincristine Sulfate (1.0 mg/ml). The following drugs had NO breakthrough detected up to 240 minutes: Please note that the following drug has low permeation times of less than 60 minutes: Carmustine (3.3 mg/ml) 30.7 minutes.
Kimberly-Clark PURPLE NITRILE-XTRA* Powder-Free Exam Glove (12" Length): A powder-free 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.
Kimberly-Clark PURPLE NITRILE* Powder-Free Exam Glove (9.5" Length): A powder-free 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.
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC
Device Description
Kimberly-Clark PURPLE NITRILE* Powder-Free Exam Gloves are 9.5-inch long, non-sterile, purplecolored nitrile, powder-free, ambidextrous patient examination glove that meets the specifications of ASTM D 6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application.
Kimberly-Clark PURPLE NITRILE-XTRA* Powder-Free Exam Gloves are 12-inch long, non-sterile, purplecolored nitrile, powder-free, ambidextrous patient examination glove that meets the specifications of ASTM D 6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application. In addition these gloves were tested for use with the drugs listed in the Intended Use(s) section below, per ASTM D6978-05 "Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs." These gloves meet the 2008 Glove Guidance Manual recommended minimum thickness and length specifications for gloves tested for use with chemotherapy drugs.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hand or finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Examiner (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 Testing:
ASTM D 6319-10 for Dimensions, Physical Properties, Freedom from pinholes, Powder Free (Powder Content). Results: Meets ASTM Requirements.
ASTM D 5151-06 for Freedom from pinholes. Results: Meets ASTM Requirements.
ASTM D 6124-06 for Powder Free (Powder Content). Results: Meets ASTM Requirements.
ISO 10993, Part 10 for ISO Skin Irritation Study and Sensitization. Results: Meets ASTM Requirements.
ISO 10993, Part 11 for ISO Systemic Toxicity Study. Results: Meets ASTM Requirements.
2008 FDA Glove Guidance Manual (for thickness and length) for Dimensions. Results: Meets ASTM Requirements and 2008 FDA Glove Guidance Manual (for thickness and length).
ASTM D 6978-05 and ASTM F 739-07 for Resistance to Permeation. Results: Meets ASTM Requirements, See Intended Use Section.
Clinical Testing: No Clinical testing was required to determine substantial equivalence of these devices.
Conclusion: The results of the non-clinical testing demonstrate that the FDA-recognized consensus standards and are substantially equivalent to the predicate devices. The results of the non-clinical testing demonstrate that the gloves meet the FDA-recognized consensus standards and are substantially equivalent to the predicate devices.
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
Image /page/0/Picture/1 description: The image shows the logo of Kimberly-Clark Corporation. The logo consists of a circular symbol with a stylized "K" inside, followed by the company name "Kimberly-Clark Corporation" in bold, sans-serif font. The text is in black, and the background is white.
MAR - 9 2012
Traditional 510(k) Notification (Bundled): Kimberly-Clark PURPLE NITRILE* Powder-Free Exam Gloves - 9.5" Length
| r and the province of the first of the first of the first of the first for the first for the first for the first for the first for the first for the first for the first for t | |||
|---|---|---|---|
| . |
| Preparation Date: | February 14, 2012 |
|---|---|
| Applicant: | Kimberly Clark Corporation |
| 1400 Holcomb Bridge Road | |
| Roswell, GA 30097 | |
| Contact Person: | Lester F. Padilla |
| Tel. No.: 678-352-6766 | |
| Trade/Proprietary Name(s): | Kimberly-Clark PURPLE NITRILE* Powder-Free Exam Gloves – |
| 9.5" | |
| Common Name(s): | Powder-Free Nitrile Patient Examination Glove |
| Classification Name: | Patient Examination Glove (21 CFR Part 880.6250), |
| Polymer Patient Examination Glove (Product Code LZA) |
Legally Marketed Device(s) to Which Substantial Equivalence is Claimed:
-
- K102032: Kimberly-Clark PURPLE NITRILE XTRA* Sterile Powder-Free Exam Gloves (Tested for Use with Chemotherapy Drugs - 12" Pairs); Kimberly-Clark PURPLE NITRILE* Sterile Powder-Free Exam Glove (Tested for Use with Chemotherapy Drugs - 9.5" Pairs); Kimberly-Clark PURPLE NITRILE* Sterile Powder-Free Exam Glove (Tested for Use with Chemotherapy Drugs - 9.5" Singles); Kimberly-Clark PURPLE NITRILE XTRA* Sterile Powder-Free Exam Gloves (12" Pairs); Kimberly-Clark PURPLE NITRILE* Powder-Free Exam Glove (9.5" Singles);
-
- K101596: Kimberly-Clark PURPLE NITRILE* Powder-Free Exam Gloves (Chemotherapy Gloves - 12"); Kimberly-Clark PURPLE * Powder-Free Exam Glove (Chemotherapy Gloves -9.5"); Kimberly-Clark PURPLE NITRILE XTRA* Powder-Free Exam Gloves (12"); Kimberly-Clark PURPLE NITRILE* Powder-Free Exam Glove (9,5"):
Device Description(s):
Kimberly-Clark PURPLE NITRILE* Powder-Free Exam Gloves are 9.5-inch long, non-sterile, purplecolored nitrile, powder-free, ambidextrous patient examination glove that meets the specifications of ASTM D 6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application.
Intended Use(s);
A powder-free 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.
Summary of Technologies:
The technological characteristics (design, specification, performance) of the Subject Devices and the Predicate Devices are substantially equivalent.
1
Traditional 510(k) Notification (Bundled): Kimberly-Clark PURPLE NITRILE* Powder-Free Exam Gloves - 9.5" Length
Non-Clinical Testing:
| Characteristics | Applicable FDA-
Recognized Standards | Performance Results |
|------------------------------------------------|-----------------------------------------|-------------------------|
| Dimensions | ASTM D 6319-10 | Meets ASTM Requirements |
| Physical Properties | ASTM D 6319-10 | Meets ASTM Requirements |
| Freedom from pinholes | ASTM D 6319-10
ASTM D 5151-06 | Meets ASTM Requirements |
| Powder Free (Powder Content) | ASTM D 6319-10
ASTM D 6124-06 | Meets ASTM Requirements |
| ISO Skin Irritation Study and
Sensitization | ISO 10993, Part 10 | Meets ASTM Requirements |
| ISO Systemic Toxicity Study | ISO 10993, Part 11 | Meets ASTM Requirements |
Clinical Testing:
No Clinical testing was required to determine substantial equivalence of these devices.
Conclusion:
The results of the non-clinical testing demonstrate that the FDA-recognized consensus standards and are substantially equivalent to the predicate devices.
2
imberly-Clark Corporation
Traditional 510(k) Notification (Bundled): Kimberly-Clark PURPLE NITRILE-XTRA* Powder-Free Exam Gloves - 12" Length
| Preparation Date: | February 14, 2012 |
|---|---|
| Applicant: | Kimberly Clark Corporation |
| 1400 Holcomb Bridge Road | |
| Roswell, GA 30097 | |
| Contact Person: | Lester F. Padilla |
| Tel. No .: 678-352-6766 | |
| Trade/Proprietary Name(s): | Kimberly-Clark PURPLE NITRILE-XTRA* Powder-Free Exam |
| Gloves - 12" Length | |
| Common Name(s): | Powder-Free Nitrile Patient Examination Gloves |
| Classification Name: | Patient Examination Glove (21 CFR Part 880.6250), |
| Polymer Patient Examination Glove (Product Code LZA) |
Section 5 - 510(k) Summary
Legally Marketed Device(s) to Which Substantial Equivalence is Claimed:
-
- K102032: Kimberly-Clark PURPLE NITRILE XTRA* Sterile Powder-Free Exam Gloves (Tested for Use with Chemotherapy Drugs - 12" Pairs); Kimberly-Clark PURPLE NITRILE* Sterile Powder-Free Exam Glove (Tested for Use with Chemotherapy Drugs - 9.5" Pairs); Kimberly-Clark PURPLE NITRILE* Sterile Powder-Free Exam Glove (Tested for Use with Chemotherapy Drugs - 9.5" Singles); Kimberly-Clark PURPLE NITRILE XTRA* Sterile Powder-Free Exam Gloves (12" Pairs); Kimberly-Clark PURPLE NITRILE* Powder-Free Exam Glove (9.5" Singles);
-
- K101596: Kimberly-Clark PURPLE NITRILE* Powder-Free Exam Gloves (Chemotherapy Gloves - 12"); Kimberly-Clark PURPLE * Powder-Free Exam Glove (Chemotherapy Gloves -9.5"); Kimberly-Clark PURPLE NITRILE XTRA* Powder-Free Exam Gloves (12"); Kimberly-Clark PURPLE NITRILE* Powder-Free Exam Glove (9.5");
Device Description(s):
Kimberly-Clark PURPLE NITRILE-XTRA* Powder-Free Exam Gloves are 12-inch long, non-sterile, purplecolored nitrile, powder-free, ambidextrous patient examination glove that meets the specifications of ASTM D 6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application.
Intended Use(s):
A powder-free patient examination glove is a disposable device intended for medical purposes that is wom on the examiner's hand or finger to prevent contamination between patient and examiner.
Summary of Technologies:
The technological characteristics (design, specification, performance) of the Subject Devices and the Predicate Devices are substantially equivalent.
3
3 Kimberly-Clark Corporation
Traditional 510(k) Notification (Bundled): Kimberly-Clark PURPLE NITRILE-XTRA* Powder-Free Exam Gloves - 12" Length
Non-Clinical Testing:
| Characteristics | Applicable
Recognized Standards | Performance Results |
|-------------------------------------------------------------------------------|------------------------------------------|-------------------------|
| Dimensions | ASTM D 6319-10 | Meets ASTM Requirements |
| Physical Properties | ASTM D 6319-10 | Meets ASTM Requirements |
| Freedom from pinholes | ASTM D 6319-10
ASTM D 5151-06 | Meets ASTM Requirements |
| Powder Free (Powder Content) | ASTM D 6319-10
ASTM D 6124-06 | Meets ASTM Requirements |
| ISO Skin Irritation Study and
Sensitization
ISO Systemic Toxicity Study | ISO 10993, Part 10
ISO 10993, Part 11 | Meets ASTM Requirements |
Clinical Testing:
No Clinical testing was required to determine substantial equivalence of these devices.
Conclusion:
The results of the non-clinical testing demonstrate that the FDA-recognized consensus standards and are substantially equivalent to the predicate devices.
4
-- *
Kimberly-Clark Corporation
:
Traditional 510(k) Notification (Bundled): Kimberly-Clark PURPLE NITRILE-XTRA* Powder-Free Exam Gloves (12") Tested for Use with Chemotherapy Drugs
| Preparation Date: | February 14, 2012 |
|---|---|
| Applicant: | Kimberly Clark Corporation |
| 1400 Holcomb Bridge Road | |
| Roswell, GA 30097 | |
| Contact Person: | Lester F. Padilla |
| Tel. No.: 678-352-6766 | |
| Trade/Proprietary Name(s): | Kimberly-Clark PURPLE NITRILE-XTRA* Powder-Free Exam |
| Gloves - 12" Length | |
| Common Name(s): | Powder-Free Nitrile Patient Examination Glove - Tested for Use |
| with Chemotherapy Drugs. | |
| Classification Name: | Patient Examination Glove (21 CFR Part 880.6250), |
| Patient Examination Glove, Specialty (Product Code LZC) |
Section 5 - 510(k) Summarv
Legally Marketed Device(s) to Which Substantial Equivalence is Claimed:
-
- K102032: Kimberly-Clark PURPLE NITRILE XTRA* Sterile Powder-Free Exam Gloves (Tested for Use with Chemotherapy Drugs - 12" Pairs); Kimberty-Clark PURPLE NITRILE* Sterile Powder-Free Exam Glove (Tested for Use with Chemotherapy Drugs - 9.5" Pairs); Kimberly-Clark PURPLE NITRILE* Sterile Powder-Free Exam Glove (Tested for Use with Chemotherapy Drugs - 9.5" Singles); Kimberly-Clark PURPLE NITRILE XTRA* Sterile Powder-Free Exam Gloves (12" Pairs); Kimberly-Clark PURPLE NITRILE* Powder-Free Exam Glove (9.5" Singles);
-
- K101596: Kimberly-Clark PURPLE NITRILE XTRA* Powder-Free Exam Gloves (Tested for Use with Chemotherapy Drugs - 12"); Kimberly-Clark PURPLE NITRILE* Powder-Free Exam Glove (Tested for Use with Chemotherapy Drugs - 9.5"); Kimberly-Clark PURPLE NITRILE XTRA* Powder-Free Exam Gloves (12"); Kimberly-Clark PURPLE NITRILE* Powder-Free Exam Glove (9.5%):
Device Description(s):
Kimberly-Clark PURPLE NITRILE-XTRA* Powder-Free Exam Gloves are 12-inch long, non-sterile, purplecolored nitrile, powder-free, ambidextrous patient examination glove that meets the specifications of ASTM D 6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application. In addition these gloves were tested for use with the drugs listed in the Intended Use(s) section below, per ASTM D6978-05 "Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs."
These gloves meet the 2008 Glove Guidance Manual recommended minimum thickness and length specifications for gloves tested for use with chemotherapy drugs.
5
(Kimberly-Clark Corporation
Traditional 510(k) Notification (Bundled): Kimberly-Clark PURPLE NITRILE-XTRA* Powder-Free Exam Gloves (12") Tested for Use with Chemotherapy Drugs
Intended Use(s):
A powder-free patient examination glove is a disposable device intended for medical purposes that is wom on the examiner's hand or finger to prevent contamination between patient and examiner.
In addition, these chemotherapy gloves were tested for use with the following drug concentrations per ASTM D6978-05:
| Bleomycin sulfate (15 mg/ml) | Gemcitabine HCI (38.0mg/ml) |
|---|---|
| Busulfan (6 mg/ml) | Idarubicin HCI (1.0mg/ml) |
| Carboplatin (10 mg/ml) | Ifosfamide (50.0 mg/ml) |
| Cisplatin (1.0 mg/ml) | Irinotecan HCI (20.0 mg/ml) |
| Cyclophosphamide (20.0 mg/ml) | Mechlorethamine HCI (1.0 mg/ml) |
| Cytarabine HCl (100 mg/ml) | Melphalan (5 mg/ml) |
| Dacarbazine (10 mg/ml) | Methotrexate (25 mg/ml) |
| Daunorubicin HCI (5.0 mg/ml) | Mitomycin-C (0.5 mg/ml) |
| Docetaxel (10.0 mg/ml) | Mitoxantrone (2.0 mg/ml) |
| Doxorubicin HCI (2.0 mg/ml) | Paclitaxel (6.0 mg/ml) |
| Epirubicin (Ellence) (2 mg/ml) | Rituximab (10 mg/ml) |
| Etoposide (20.0 mg/ml) | ThioTEPA (10.0 mg/ml) |
| Fludarabine (25 mg/ml) | Trisenox (0.1 mg/ml) |
| Fluorouracil (50.0 mg/ml) | Vincristine Sulfate (1.0 mg/ml) |
The following drugs had NO breakthrough detected up to 240 minutes:
Please note that the following drug has low permeation times of less than 60 minutes: Carmustine (3.3 mg/ml) 30.7 minutes
Summary of Technologies:
The technological characteristics (design, specification, performance) of the Subject Devices and the Predicate Devices are substantially equivalent.
6
Kimberly-Clark Corporation
Traditional 510(k) Notification (Bundled): Kimberly-Clark PURPLE NITRILE-XTRA* Powder-Free Exam Gloves (12") Tested for Use with Chemotherapy Drugs
Non-Clinical Testing:
| Characteristics | Applicable
FDA-
Recognized Standards | Performance Results |
|------------------------------------------------|------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| Dimensions | ASTM D 6319-10
and
2008 FDA Glove
Guidance Manual (for
thickness and length) | Meets ASTM Requirements
and
2008 FDA Glove Guidance
Manual (for thickness and
length) |
| Physical Properties | ASTM D 6319-10 | Meets ASTM Requirements |
| Freedom from pinholes | ASTM D 6319-10
ASTM D 5151-06 | Meets ASTM Requirements |
| Powder Free (Powder Content) | ASTM D 6319-10
ASTM D 6124-06 | Meets ASTM Requirements |
| ISO Skin Irritation Study and
Sensitization | ISO 10993, Part 10 | Meets ASTM Requirements |
| ISO Systemic Toxicity Study | ISO 10993, Part 11 | Meets ASTM Requirements |
| Resistance to Permeation | ASTM D 6978-05 and
ASTM F 739-07 | Meets ASTM Requirements
See Intended Use Section |
Clinical Testing:
No Clinical testing was required to determine substantial equivalence of these devices.
Conclusion:
The results of the non-clinical testing demonstrate that the gloves meet the FDA-recognized consensus standards and are substantially equivalent to the predicate devices.
7
Image /page/7/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The eagle is composed of three thick, curved lines that suggest the shape of the bird's body and wings.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Kimberly-Clark Corporation C/O Mr. Ned Devine Responsible Third Party Official Underwriters Laboratories, Inc. 333 Pfingsten Road Northbrook, Illinois 60062
Re: K113423
Trade/Device Name: Kimberly-Clark PURPLE NITRILE-XTRA* Powder-Free Exam Glove with Tested for Use with Chemotherapy Drugs Labeling Claim (12" Length)
Kimberly-Clark Purple NITRILE-XTRA* Powder-Free Exam Glove (12" Length)
Kimberly-Clark PURPLE NITRILE* Powder-Free Exam Glove i (9.5" Length)
Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA, LZC Dated: February 23, 2012
Received: February 24, 2012
Dear Mr. Devine:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
MAR - 9 2012
8
Page 2 - Mr. Ned Devine
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health.'s (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Anthony
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital;
Infection Control and Dental Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
9
ളും Kimberly-Clark Corporation
Indications for Use
510(k) Number (if known): K113423
Device Name(s):
Kimberly-Clark PURPLE NITRILE-XTRA* Powder-Free Exam Glove With Tes Te d FOR USE WITH OFFEMOTHERAPY DRUGS LABELING CLAIM - 12" Length Indications for Use:
A powder-free 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.
In addition, these chemotherapy gloves were tested for use with the following drug concentrations per ASTM D6978-05:
The following drugs had NO breakthrough detected up to 240 minutes:
| Bleomycin sulfate (15 mg/ml) | Gemcitabine HCl (38.0mg/ml) |
|---|---|
| Busulfan (6 mg/ml) | Idarubicin HCl (1.0mg/ml) |
| Carboplatin (10 mg/ml) | Ifosfamide (50.0 mg/ml) |
| Cisplatin (1.0 mg/ml) | Irinotecan HCl (20.0 mg/ml) |
| Cyclophosphamide (20.0 mg/ml) | Mechlorethamine HCl (1.0 mg/ml) |
| Cytarabine HCl (100 mg/ml) | Melphalan (5 mg/ml) |
| Dacarbazine (10 mg/ml) | Methotrexate (25 mg/ml) |
| Daunorubicin HCl (5.0 mg/ml) | Mitomycin-C (0.5 mg/ml) |
| Docetaxel (10.0 mg/ml) | Mitoxantrone (2.0 mg/ml) |
| Doxorubicin HCl (2.0 mg/ml) | Paclitaxel (6.0 mg/ml) |
| Epirubicin (Ellence) (2 mg/ml) | Rituximab (10 mg/ml) |
| Etoposide (20.0 mg/ml) | ThioTEPA (10.0 mg/ml) |
| Fludarabine (25 mg/ml) | Trisenox (0.1 mg/ml) |
| Fluorouracil (50.0 mg/ml) | Vincristine Sulfate (1.0 mg/ml) |
Please note that the following drug has low permeation times of less than 60 minutes: Carmustine (3.3 mg/ml) 30.7 minutes
Page 1 of 2
Eliz.th T. Channing-Williams
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
14113423 510(k) Number:
10
ි | Kimberly-Clark Corporation
Indications for Use (cont'd)
510(k) Number (if known): J≤ 1) 3423
Device Name(s): Kimberly-Clark PURPLE NITRILE-XTRA* Powder-Free Exam Glove
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 2 of 2
Elizabeth F. Clamie-Willens
(Division Sign-Jif) (Division Sign-Chr)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices . Avision Control, Dental Devices
i10(k) Number: K 113423
11
ලිපි Kimberly-Clark Corporation
Indications for Use
510(k) Number (if known):
Device Name(s):
Kimberly-Clark PURPLE NITRILE-XTRA* Powder-Free Exam Glove (12" Length)
Indications for Use:
A powder-free 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.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Erlabeth F. Clavine-Williams
Page 1 of 1_
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K113423
12
Image /page/12/Picture/1 description: The image shows the logo for Kimberly-Clark Corporation. The logo consists of a stylized symbol to the left of the company name. The text "Kimberly-Clark Corporation" is written in a bold, sans-serif font.
Indications for Use
510(k) Number (if known): _ K // 3423
Device Name(s):
Kimberly-Clark PURPLE NITRILE* Powder-Free Exam Glove (9.5" Length)
Indications for Use:
A powder-free 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.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabeth F. Clamin-Will
Page 1 of 1
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
K113423 510(k) Number: