(43 days)
Not Found
No
The device is a physical examination glove and the summary describes its material properties and testing against chemotherapy drugs. There is no mention of any software, algorithms, or data processing that would involve AI or ML.
No.
Explanation: The device is a patient examination glove intended to prevent contamination and protect the examiner from certain chemotherapy drugs. It does not provide any therapeutic benefit to a patient.
No
The device is a patient examination glove used to prevent contamination, not to diagnose a medical condition.
No
The device described is a physical medical device (examination gloves) and does not involve any software component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "powder-free patient examination glove... worn on the examiner's hand or finger to prevent contamination between patient and examiner." This describes a barrier device for protection, not a device used to perform tests on samples taken from the human body to diagnose diseases or conditions.
- Device Description: The description reinforces that it's a glove meeting standards for medical examination gloves and tested for resistance to chemotherapy drugs. This is about protecting the user from exposure, not analyzing a sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to diagnosing a condition based on in vitro testing.
The testing for chemotherapy drug permeation is a safety feature for the user, not a diagnostic function.
N/A
Intended Use / Indications for Use
Kimberly-Clark PURPLE NITRILE-XTRA* Powder-Free Exam Gloves (Chemotherapy Gloves): 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 (15.0mg/ml), Busulfan (6.0mg/ml), Carboplatin (10.0mg/ml), Cisplatin (1 mg/ml), Cyclophosphamide (20 mg/ml), Cytarabine HCl (100.0mg/ml), Dacarbazine (10 mg/ml), Daunorubicin Hcl (5.0mg/ml), Docetaxel (10.0mg/ml), Doxorubicin HCl (Adriamycin) (2 mg/ml), Ellence (Epirubicin) (2.0mg/ml), Etoposide (20 mg/ml), Fludarabine (25.0mg/ml), Fluorouracil (adrucil) (50 mg/ml), Gemcitabine (38.0mg/ml), Idarubicin (1.0mg/ml), Ifosfamide (50mg/ml), Irinotecan (20.0mg/ml), Mechlorethamine HCl (1.0mg/ml), Melphalan (5.0mg/ml), Methotrexate (25.0mg/ml), Mitomycin (0.5mg/ml), Mitoxantrone (2 mg/ml), Paclitaxel (Taxol) (6 mg/ml), Paraplatin (10.0mg/ml), Rituximab (10.0mg/ml), Trisenox (0.1mg/ml), Vincrinstine Sulfate (1 mg/ml). The following drugs showed breakthrough detected in less than 30 minutes: Carmustine (3.3mg/ml): 1.8 minutes, ThioTEPA (10.0mg/ml): 1.7 minutes. Warning - Not for Use with Carmustine and ThioTEPA.
Kimberly-Clark PURPLE NITRILE* Powder-Free Exam Gloves (Chemotherapy Gloves): 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 (15.0mg/ml), Busulfan (6.0mg/ml), Carboplatin (10.0mg/ml), Cisplatin (1 mg/ml), Cyclophosphamide (20 mg/ml), Cytarabine HCl (100.0mg/ml), Dacarbazine (10 mg/ml), Daunorubicin Hcl (5.0mg/ml), Docetaxel (10.0mg/ml), Doxorubicin HCl (Adriamycin) (2 mg/ml), Ellence (Epirubicin) (2.0mg/ml), Etoposide (20 mg/ml), Fludarabine (25.0mg/ml), Fluorouracil (adrucil) (50 mg/ml), Gemcitabine (38.0mg/ml), Idarubicin (1.0mg/ml), Ifosfamide (50mg/ml), Irinotecan (20.0mg/ml), Mechlorethamine HCl (1.0mg/ml), Melphalan (5.0mg/ml), Methotrexate (25.0mg/ml), Mitomycin (0.5mg/ml), Mitoxantrone (2 mg/ml), Paclitaxel (Taxol) (6 mg/ml), Paraplatin (10.0mg/ml), Rituximab (10.0mg/ml), Trisenox (0.1mg/ml), Vincrinstine Sulfate (1 mg/ml). The following drugs showed breakthrough detected in less than 30 minutes: Carmustine (3.3mg/ml): 1.8 minutes, ThioTEPA (10.0mg/ml): 1.7 minutes. Warning - Not for Use with Carmustine and ThioTEPA.
Kimberly-Clark PURPLE NITRILE-XTRA* Powder-Free Exam Gloves: 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 Gloves: 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)
LZC, LZA
Device Description
Kimberly-Clark PURPLE NITRILE-XTRA* Powder-Free Exam Gloves (Chemotherapy Glove) are 12inch long, non-sterile purple-colored nitrile, powder-free, ambidextrous patient examination glove that meets all of the requirements of ASTM D6319-00a, 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."
Kimberly-Clark PURPLE NITRILE* Powder-Free Exam Gloves (Chemotherapy Glove) are 9.5-inch long, non-sterile purple-colored nitrile, powder-free, ambidextrous patient examination glove that meets all of the requirements of ASTM D6319-00a, 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."
Kimberly-Clark PURPLE NITRILE-XTRA* Powder-Free Exam Gloves Powder-Free Exam Gloves are 12-inch long, non-sterile purple-colored nitrile, powder-free, ambidextrous patient examination glove that meets all of the requirements of ASTM D6319-00a, Standard Specification for Nitrile Examination Gloves for Medical Application.
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 all of the requirements of ASTM D6319-00a, 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 or finger
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 testing was performed. For Kimberly-Clark PURPLE NITRILE-XTRA* Powder-Free Exam Gloves (Chemotherapy Glove): Resistance to Permeation per ASTM D6978-05 and/or ASTM F739-07. Results meet ASTM Requirements. For Kimberly-Clark PURPLE NITRILE* Powder-Free Exam Gloves (Chemotherapy Glove): Resistance to Permeation per ASTM D6978-05 and/or ASTM F 739-07. Results meet ASTM Requirements. For Kimberly-Clark PURPLE NITRILE-XTRA* Powder-Free Exam Gloves and Kimberly-Clark PURPLE NITRILE* Powder-Free Exam Gloves for general patient examination use, tests for Dimensions, Physical Properties, Freedom from pinholes, Powder Free (Powder Content), ISO Skin Irritation Study and Sensitization, and ISO Cytotoxicity Study were performed. All results meet ASTM Requirements.
No Clinical testing was required to determine substantial equivalence of these 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
JUL 2-1 2010
Traditional 510(k) Notification: Kimberly-Clark PURPLE NITRILE-XTRA* Powder-Free Exam Gloves (Chemotherapy)
| Preparation Date: | 30 June 2010 |
|---|---|
| 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 (Chemotherapy Glove) | |
| Common Name(s): | Powder-Free Nitrile Patient Examination Chemotherapy Use Gloves |
| Classification Name: | Patient Examination Glove, Specialty (21 CFR Part 880.6250 - |
| Product Code LZC) |
Section 5 - 510(k) Summary
Legally Marketed Device(s) to Which Substantial Equivalence is Claimed:
-
- Safeskin Purple Powder-Free Nitrile Examination Gloves for Use with Chemotherapeutic Drugs Labeling Claim - K992162
- Kimberly-Clark STERLING* Nitrile & STERLING* NITRILE-XTRA* Powder-Free Exam Gloves 2. with Chemotherapy Drug Use Claim - K081089
-
- Kimberly-Clark LAVENDER* Nitrile Powder-Free Examination Glove K081260
Device Description(s):
Kimberly-Clark PURPLE NITRILE-XTRA* Powder-Free Exam Gloves (Chemotherapy Glove) are 12inch long, non-sterile purple-colored nitrile, powder-free, ambidextrous patient examination glove that meets all of the requirements of ASTM D6319-00a, 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."
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 palient and examiner.
In addition, these chemotherapy gloves were tested for use with the following drug concentrations per ASTM D6978-05:
1
Traditional 510(k) Notification: Kimberly-Clark PURPLE NITRILE-XTRA* Powder-Free Exam Gloves (Chemotherapy)
· The following drugs had NO breakthrough detected up to 240 minutes:
| Bleomycin sulfate (15.0mg/ml) | Gemcitabine (38.0mg/ml) |
|---|---|
| Busulfan (6.0mg/ml) | Idarubicin (1.0mg/ml) |
| Carboplatin (10.0mg/ml) | Ifosfamide (50mg/ml) |
| Cisplatin (1 mg/ml) | Irinotecan (20.0mg/ml) |
| Cyclophosphamide (20 mg/ml) | Mechlorethamine HCl (1.0mg/ml) |
| Cytarabine HCl (100.0mg/ml) | Melphalan (5.0mg/ml) |
| Dacarbazine (10 mg/ml) | Methotrexate (25.0mg/ml) |
| Daunorubicin Hcl (5.0mg/ml) | Mitomycin (0.5mg/ml) |
| Docetaxel (10.0mg/ml) | Mitoxantrone (2 mg/ml) |
| Doxorubicin HCI (Adriamycin) (2 mg/ml) | Paclitaxel (Taxol) (6 mg/ml) |
| Ellence (Epirubicin) (2.0mg/ml) | Paraplatin (10.0mg/ml) |
| Etoposide (20 mg/ml) | Rituximab (10.0mg/ml) |
| Fludarabine (25.0mg/ml) | Trisenox (0.1mg/ml) |
| Fluorouracil (adrucil) (50 mg/ml) | Vincrinstine Sulfate (1 mg/ml) |
The following drugs showed breakthrough detected in less than 30 minutes:
| Carmustine (3.3mg/ml): 1.8 minutes
ThioTEPA (10.0mg/ml): 1.7 minutes
| Comments of the control a province a desire a desire a de control a de control a province a formation a formation and consideration and consideration of the formation of the |
|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
Warning - Not for Use with Carmustine and ThioTEPA
Summary of Technologies:
The technological characteristics (design, specification, performance) of the Subject Devices and the Predicate Devices are substantially equivalent.
Non-Clinical Testing (Subject Device):
| Characteristics | Applicable FDA-
Recognized Standards | Performance Results |
|------------------------------------------------|-----------------------------------------|---------------------------------------------------------------------|
| Dimensions | ASTM D6319-00a | Meets ASTM Requirements |
| Physical Properties | ASTM D6319-00a | Meets ASTM Requirements |
| Freedom from pinholes | ASTM D6319-00a
ASTM D5151-06 | Meets ASTM Requirements |
| Powder Free (Powder Content) | ASTM D6319-00a
ASTM D6124-06 | Meets ASTM Requirements |
| ISO Skin Irritation Study and
Sensitization | ISO 10993, Part 10 | Meets ASTM Requirements |
| ISO Cytotoxicity Study | ISO 10993, Part 5 | Meets ASTM Requirements |
| Resistance to Permeation | ASTM D6978-05 and/or
ASTM F739-07 | Meets ASTM Requirements
See Intended Use Section for
Device 1 |
2
Traditional 510(k) Notification: Kimberly-Clark PURPLE NITRILE-XTRA* Powder-Free Exam Gloves (Chemotherapy)
3
101596
ഇടി Kimberly-Clark Corporation
Traditional 510(k) Notification: Kimberly-Clark PURPLE NITRILE-XTRA* Powder-Free Exam Gloves (Chemotherapy)
Clinical Testing:
No Clinical testing was required to determine substantial equivalence of these devices.
Conclusion:
The results of the non-dinical testing demonstrate that the gloves meet the FDA-recognized consensus standards and are substantially equivalent to the predicate devices.
4
101596
ලිපු Kimberly-Clark Corporation
Traditional 510(k) Notification: Kimberly-Clark PURPLE NITRILE* Powder-Free Exam Gloves (Chemotherapy)
| Preparation Date: | 30 June 2010 |
|---|---|
| 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 |
| (Chemotherapy Glove) | |
| Common Name(s): | Powder-Free Nitrile Patient Examination Chemotherapy Use Gloves |
| Classification Name: | Patient Examination Glove, Specialty (21 CFR Part 880.6250 - |
| Product Code LZC) |
Section 5 - 510(k) Summary
Legally Marketed Device(s) to Which Substantial Equivalence is Claimed:
- Safeskin Purple Powder-Free Nitrile Examination Gloves for Use with Chemotherapeutic Drugs 1 . Labeling Claim - K992162
- Kimberly-Clark STERLING* Nitrile & STERLING* NITRILE-XTRA* Powder-Free Exam Gloves 2. with Chemotherapy Drug Use Claim - K081089
-
- Kimberly-Clark LAVENDER* Nitrile Powder-Free Examination Glove K081260
Device Description(s):
Kimberly-Clark PURPLE NITRILE* Powder-Free Exam Gloves (Chemotherapy Glove) are 9.5-inch long, non-sterile purple-colored nitrile, powder-free, ambidextrous patient examination glove that meets all of the requirements of ASTM D6319-00a, 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."
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.
In addition, these chemotherapy gloves were tested for use with the following drug concentrations per ASTM D6978-05:
5
Traditional 510(k) Notification: Kimberly-Clark PURPLE NITRILE* Powder-Free Exam Gloves (Chemotherapy)
The following drugs had NO breakthrough detected up to 240 minutes:
| Bleomycin sulfate (15.0mg/ml) | Gemcitabine (38.0mg/ml) |
|---|---|
| Busulfan (6.0mg/ml) | Idarubicin (1.0mg/ml) |
| Carboplatin (10.0mg/ml) | Ifosfamide (50mg/ml) |
| Cisplatin (1 mg/ml) | Irinotecan (20.0mg/ml) |
| Cyclophosphamide (20 mg/ml) | Mechlorethamine HCl (1.0mg/ml) |
| Cytarabine HCl (100.0mg/ml) | Melphalan (5.0mg/ml) |
| Dacarbazine (10 mg/ml) | Methotrexate (25.0mg/ml) |
| Daunorubicin Hcl (5.0mg/ml) | Mitomycin (0.5mg/ml) |
| Docetaxel (10.0mg/ml) | Mitoxantrone (2 mg/ml) |
| Doxorubicin HCI (Adriamycin) (2 mg/ml) | Paclitaxel (Taxol) (6 mg/ml) |
| Ellence (Epirubicin) (2.0mg/ml) | Paraplatin (10.0mg/ml) |
| Etoposide (20 mg/ml) | Rituximab (10.0mg/ml) |
| Fludarabine (25.0mg/ml) | Trisenox (0.1mg/ml) |
| Fluorouracil (adrucil) (50 mg/ml) | Vincrinstine Sulfate (1 mg/ml) |
The following drugs showed breakthrough detected in less than 30 minutes:
| Carmustine (3.3mg/ml): 1.8 minutes | ThioTEPA (10.0mg/ml): 1.7 minutes |
|---|---|
| ------------------------------------ | ----------------------------------- |
Warning - Not for Use with Carmustine and ThioTEPA
Summary of Technologies:
The technological characteristics (design, specification, performance) of the Subject Devices and the Predicate Devices are substantially equivalent.
Non-Clinical Testing (Subject Device):
| Characteristics | Applicable FDA-
Recognized Standards | Performance Results |
|------------------------------------------------|-----------------------------------------|-----------------------------------------------------|
| Dimensions | ASTM D6319-00a | Meets ASTM Requirements |
| Physical Properties | ASTM D6319-00a | Meets ASTM Requirements |
| Freedom from pinholes | ASTM D6319-00a
ASTM D5151-06 | Meets ASTM Requirements |
| Powder Free (Powder Content) | ASTM D6319-00a
ASTM D6124-06 | Meets ASTM Requirements |
| ISO Skin Irritation Study and
Sensitization | ISO 10993, Part 10 | Meets ASTM Requirements |
| ISO Cytotoxicity Study | ISO 10993, Part 5 | |
| Resistance to Permeation | ASTM D6978-05 and/or
ASTM F 739-07 | Meets ASTM Requirements
See Intended Use Section |
6
K101596
്ട്ടി Kimberly-Clark Corporation
Traditional 510(k) Notification: Kimberly-Clark PURPLE NITRILE* Powder-Free Exam Gloves (Chemotherapy)
Clinical Testing:
No Clinical testing was required to determine substantial equivalence of these devices.
Conclusion:
The results of the non-dinical testing demonstrate that the FDA-recognized consensus standards and are substantially equivalent to the predicate devices.
7
Traditional 510(k) Notification: Kimberly-Clark PURPLE NITRILE* Powder-Free Exam Gloves
| Preparation Date: | 30 June 2010 |
|---|---|
| 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 |
| Common Name(s): | Powder-Free Nitrile Patient Examination Gloves |
| Classification Name: | Polymer Patient Examination Glove (21 CFR Part 880.6250 - |
| Product Code LZA) |
Section 5 - 510(k) Summary
Legally Marketed Device(s) to Which Substantial Equivalence is Claimed:
-
- Safeskin Purple Powder-Free Nitrile Examination Gloves for Use with Chemotherapeutic Drugs Labeling Claim - K992162
-
- Kimberly-Clark STERLING* Nitrile & STERLING* NITRILE-XTRA* Powder-Free Exam Gloves with Chemotherapy Drug Use Claim - K081089
-
- Kimberly-Clark LAVENDER* Nitrile Powder-Free Examination Glove - K081260
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 all of the requirements of ASTM D6319-00a, 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.
8
Traditional 510(k) Notification: Kimberly-Clark PURPLE NITRILE* Powder-Free Exam Gloves
Non-Clinical Testing (Subject Device):
| Characteristics | Applicable FDA-
Recognized Standards | Performance Results |
|------------------------------------------------|-----------------------------------------|-------------------------|
| Dimensions | ASTM D 6319-00a | Meets ASTM Requirements |
| Physical Properties | ASTM D 6319-00a | Meets ASTM Requirements |
| Freedom from pinholes | ASTM D 6319-00a
ASTM D 5151-06 | Meets ASTM Requirements |
| Powder Free (Powder Content) | ASTM D 6319-00a
ASTM D 6124-06 | Meets ASTM Requirements |
| ISO Skin Irritation Study and
Sensitization | ISO 10993, Part 10 | Meets ASTM Requirements |
| ISO Cytotoxicity Study | ISO 10993, Part 5 | 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.
9
Traditional 510(k) Notification: Kimberly-Clark PURPLE NITRILE-XTRA* Powder-Free Exam Gloves
| Preparation Date: | 30 June 2010 |
|---|---|
| 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 | |
| Common Name(s): | Powder-Free Nitrile Patient Examination Gloves |
| Classification Name: | Polymer Patient Examination Glove (21 CFR Part 880.6250 - |
| Product Code LZA) |
Section 5 - 510(k) Summary
Legally Marketed Device(s) to Which Substantial Equivalence is Claimed:
- Safeskin Purple Powder-Free Nitrile Examination Gloves for Use with Chemotherapeutic Drugs 1. Labeling Claim - K992162
- Kimberly-Clark STERLING* Nitrile & STERLING* NITRILE-XTRA* Powder-Free Exam Gloves 2. with Chemotherapy Drug Use Claim - K081089
-
- Kimberly-Clark LAVENDER* Nitrile Powder-Free Examination Glove K081260
Device Description(s):
Kimberly-Clark PURPLE NITRILE-XTRA* Powder-Free Exam Gloves are 12-inch long, non-sterile purple-colored nitrile, powder-free, ambidextrous patient examination glove that meets all of the requirements of ASTM D6319-00a, 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.
10
Traditional 510(k) Notification: Kimberly-Clark PURPLE NITRILE-XTRA* Powder-Free Exam Gloves
Non-Clinical Testing (Subject Device):
| Characteristics | Applicable FDA-
Recognized Standards | Performance Results |
|--------------------------------------------------------------------------|-----------------------------------------|-------------------------|
| Dimensions | ASTM D6319-00a | Meets ASTM Requirements |
| Physical Properties | ASTM D6319-00a | Meets ASTM Requirements |
| Freedom from pinholes | ASTM D6319-00a
ASTM D5151-06 | Meets ASTM Requirements |
| Powder Free (Powder Content) | ASTM D6319-00a
ASTM D6124-06 | Meets ASTM Requirements |
| ISO Skin Irritation Study and
Sensitization
ISO Cytotoxicity Study | ISO 10993, Part 10
ISO 10993, Part 5 | 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 gloves meet the FDA-recognized consensus standards and are substantially equivalent to the predicate devices.
11
Image /page/11/Picture/0 description: The image shows a partial view of the seal for the Department of Health & Human Services. The seal includes the department's name around the perimeter and a stylized caduceus symbol in the center. The caduceus is depicted with a staff and intertwined snakes, representing medicine and healing. The image is in black and white.
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 C/O Mr. Ned Devine Responsible Third Party Official Underwriters Laboratories Incorporated 333 Pfingsten Road Northbrook, Illinois 60062
JUL 21 2010
Re: K101596
Trade/Device Name: Kimberly -Clark PURPLE NITRILE Powder-Free Exam Glove (Chemotherapy Gloves)
Kimberly -Clark PURPLE NITRILE -XTRA Powder-Free Exam Glove (Chemotherapy Gloves)
Kimberly -Clark PURPLE NITRILE Powder-Free Exam Glove Kimberly -Clark PURPLE NITRILE -XTRA * Powder-Free Exam Glove
Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZC, LZA Dated: July 2, 2010 Received: July 6, 2010
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.
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
12
Page 2-Mr. Devine
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,
for
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
Enclosure
13
යි හි Kimberly-Clark Corporation
Indications for Use
510(k) Number (if known):
Device Name(s):
Kimberly-Clark PURPLE NITRILE* Powder-Free Exam Gloves (Chemotherapy Gloves)
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 (15.0mg/ml) | Gemcitabine (38.0mg/ml) |
|---|---|
| Busulfan (6.0mg/ml) | Idarubicin (1.0mg/ml) |
| Carboplatin (10.0mg/ml) | Ifosfamide (50mg/ml) |
| Cisplatin (1 mg/ml) | Irinotecan (20.0mg/ml) |
| Cyclophosphamide (20 mg/ml) | Mechlorethamine HCl (1.0mg/ml) |
| Cytarabine HCl (100.0mg/ml) | Melphalan (5.0mg/ml) |
| Dacarbazine (10 mg/ml) | Methotrexate (25.0mg/ml) |
| Daunorubicin Hcl (5.0mg/ml) | Mitomycin (0.5mg/ml) |
| Docetaxel (10.0mg/ml) | Mitoxantrone (2 mg/ml) |
| Doxorubicin HCl (Adriamycin) (2 mg/ml) | Paclitaxel (Taxol) (6 mg/ml) |
| Ellence (Epirubicin) (2.0mg/ml) | Paraplatin (10.0mg/ml) |
| Etoposide (20 mg/ml) | Rituximab (10.0mg/ml) |
| Fludarabine (25.0mg/ml) | Trisenox (0.1mg/ml) |
| Fluorouracil (adrucil) (50 mg/ml) | Vincrinstine Sulfate (1 mg/ml) |
The following drugs showed breakthrough detected in less than 30 minutes:
Carmustine (3.3mg/ml): 1.8 minutes : ThioTEPA (10.0mg/ml): 1.7 minutes
Warning - Not for Use with Carmustine and ThioTEPA
Page 1 of 2
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: __
14
Indications for Use
510(k) Number (if known):
Device Name(s):
Kimberly-Clark PURPLE NITRILE-XTRA* Powder-Free Exam Gloves (Chemotherapy Gloves)
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 (15.0mg/ml) | Gemcitabine (38.0mg/ml) |
| Busulfan (6.0mg/ml) | Idarubicin (1.0mg/ml) |
| Carboplatin (10.0mg/ml) | Ifosfamide (50mg/ml) |
| Cisplatin (1 mg/ml) | Irinotecan (20.0mg/ml) |
| Cyclophosphamide (20 mg/ml) | Mechlorethamine HCl (1.0mg/ml) |
| Cytarabine HCl (100.0mg/ml) | Melphalan (5.0mg/ml) |
| Dacarbazine (10 mg/ml) | Methotrexate (25.0mg/ml) |
| Daunorubicin Hcl (5.0mg/ml) | Mitomycin (0.5mg/ml) |
| Docetaxel (10.0mg/ml) | Mitoxantrone (2 mg/ml) |
| Doxorubicin HCl (Adriamycin) (2 mg/ml) | Paclitaxel (Taxol) (6 mg/ml) |
| Ellence (Epirubicin) (2.0mg/ml) | Paraplatin (10.0mg/ml) |
| Etoposide (20 mg/ml) | Rituximab (10.0mg/ml) |
| Fludarabine (25.0mg/ml) | Trisenox (0.1mg/ml) |
| Fluorouracil (adrucil) (50 mg/ml) | Vincrinstine Sulfate (1 mg/ml) |
The following drugs had NO breakthrough detected up to 240 minutes:
The following drugs showed breakthrough detected in less than 30 minutes:
Carmustine (3.3mg/ml): 1.8 minutes ThioTEPA (10.0mg/ml): 1.7 minutes
Warning - Not for Use with Carmustine and ThioTEPA
Page 1 of 2
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
15
Indications for Use
510(k) Number (if known):
Device Name(s):
Kimberly-Clark PURPLE NITRILE* Powder-Free Exam Gloves
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)
Page 1 of 1
signature
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
16
Indications for Use
510(k) Number (if known): K 101596
Device Name(s):
Kimberly-Clark PURPLE NITRILE-XTRA* Powder-Free Exam Gloves
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)
Page 1 of 1
(Division Sign-Uff) Division of Anesthesiology. General Hospital Infection Control, Dental Os neas
510(k) Number: |