KIMBERLY-CLARK PURPLE NITRILE XTRA* STERILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) - 12 STERILE PAIRS
Device Facts
| Record ID | K102032 |
|---|---|
| Device Name | KIMBERLY-CLARK PURPLE NITRILE XTRA* STERILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) - 12 STERILE PAIRS |
| Applicant | Kimberly-Clark Corp. |
| Product Code | LZA · General Hospital |
| Decision Date | Sep 8, 2010 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6250 |
| Device Class | Class 1 |
| Attributes | 3rd-Party Reviewed |
Intended 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.
Device Story
Sterile, powder-free, ambidextrous nitrile examination gloves; available in 9.5-inch and 12-inch lengths; packaged as singles or pairs. Designed for use by healthcare professionals to provide a barrier against contamination. Chemotherapy-labeled versions tested for permeation resistance against a specific list of chemotherapy drugs per ASTM D6978-05. Gloves function as a physical barrier; no active components or software. Used in clinical settings to protect both patient and examiner during examinations and handling of hazardous drugs.
Clinical Evidence
No clinical testing was required to determine substantial equivalence. Evidence is based on bench testing, including physical properties, dimensions, freedom from pinholes, powder content, and biocompatibility (ISO 10993-5/10). Chemotherapy-labeled variants include bench-based permeation testing per ASTM D6978-05.
Technological Characteristics
Material: Nitrile. Form factor: 9.5-inch or 12-inch ambidextrous gloves. Standards: ASTM D6319-00a (physical/dimensional), ASTM D5151-06 (pinholes), ASTM D6124-06 (powder content), ASTM D6978-05/F739-07 (chemotherapy permeation), ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation/sensitization). Sterilization: Sterile. Connectivity: None. Algorithm: None.
Indications for Use
Indicated for use as a disposable patient examination glove worn by clinicians to prevent cross-contamination between patient and examiner. Chemotherapy-labeled variants are indicated for use during handling of specific chemotherapy drugs as tested per ASTM D6978-05.
Regulatory Classification
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.
Predicate Devices
- Safeskin Sterile PURPLE NITRILE* Examination Gloves (Powder-Free) (K992062)
- Safeskin PURPLE* Powder-Free Nitrile Examination Gloves for Use with Chemotherapeutic Drugs (K992162)
- Kimberly-Clark Sterling Nitrile & Nitrile Xtra Powder-Free Exam Gloves with Chemotherapy Drug Use Claim (K081089)
- Kimberly-Clark Sterling Nitrile Powder-Free Exam Glove (K081027)
Related Devices
- K101596 — KIMBERLY-CLARK PURPLE NITRILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) AND KIMBERLY-CLARK PURPLE NITRILE XTRA POWDER- · Kimberly-Clark · Jul 21, 2010
- K113423 — KIMBERLY CLARK PURPLE NITRILE, AND PURPLE NITRILE XTRA POWDER FREE EXAM GLOVE · Kimberly-Clark Corp. · Mar 9, 2012
- K220118 — Nitrile Powder Free Examination Gloves, Chemotherapy Nitrile Powder Free Examination Gloves · Kl-Kepong Rubber Products Sdn. Bhd. · May 12, 2022
- K220547 — PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile Powder-Free Exam Gloves · O&M Halyard, Inc. · Jun 2, 2022
- K232039 — Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate · Grand Work Plastic Products Co., Ltd. · Aug 9, 2023
Submission Summary (Full Text)
{0}------------------------------------------------
K102032
## Traditional 510(k) Notification (Bundled): Kimberly-Clark PURPLE NITRILE-XTRA* Sterile Powder-Free Exam Gloves - 12" Pairs
### Section 5 - 510(k) Summary
| Preparation Date: | July 06, 2010 |
|----------------------------|-----------------------------------------------------------------------------------------------------------|
| Applicant: | Kimberly Clark Corporation<br>1400 Holcomb Bridge Road<br>Roswell, GA 30097 |
| Contact Person: | Lester F. Padilla<br>Tel. No.: 678-352-6766 |
| Trade/Proprietary Name(s): | Kimberly-Clark PURPLE NITRILE-XTRA* Sterile Powder-Free<br>Exam Gloves - 12" Pairs |
| Common Name(s): | Powder-Free Nitrile Patient Examination Gloves (Sterile) |
| Classification Name: | Patient Examination Glove (21 CFR Part 880.6250),<br>Polymer Patient Examination Glove (Product Code LZA) |
## Legally Marketed Device(s) to Which Substantial Equivalence is Claimed:
3 Kimberly-Clark Corporation
- Safeskin Sterile PURPLE NITRILE* Examination Gloves (Powder-Free) K992062 】.
- Safeskin PURPLE* Powder-Free Nitrile Examination Gloves for Use with Chemotherapeutic 2. Drugs Labeling Claim - K992162
- 3. Kimberly-Clark Sterling Nitrile & Nitrile Xtra Powder-Free Exam Gloves with Chemotherapy Drug Use Claim - K081089
- Kimberly-Clark Sterling Nitrile Powder-Free Exam Glove K081027 4.
#### Device Description(s):
Kimberly-Clark PURPLE NITRILE-XTRA* Sterile Powder-Free Exam Gloves are 12-inch long, sterile, purple-colored nitrile, powder-free, ambidextrous patient examination glove that meets all of the requirements of ASTM D 6319-00a, Standard Specification for Nitrile Examination Gloves for Medical Application. The gloves are packaged as two gloves per sterile pouch.
{1}------------------------------------------------
## Traditional 510(k) Notification (Bundled): Kimberly-Clark PURPLE NITRILE-XTRA* Sterile Powder-Free Exam Gloves - 12" Pairs
#### Intended Use(s):
A powder-free pațient 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.
#### Non-Clinical Testing:
| Characteristics | Applicable<br>Recognized Standards | FDA- | 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 | | Meets ASTM Requirements |
| | ASTM D 5151-06 | | |
| Powder Free (Powder Content) | ASTM D 6319-00a | | Meets ASTM Requirements |
| | ASTM D 6124-06 | | |
| ISO Skin Irritation Study and<br>Sensitization | ISO 10993, Part 10 | | Meets ASTM Requirements |
| ISO Cytotoxicity Study | ISO 10993, Part 5 | | |
#### 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.
{2}------------------------------------------------
## Traditional 510(k) Notification (Bundled): Kimberly-Clark PURPLE NITRILE* Sterile Powder-Free Exam Gloves - 9.5" Pairs
| Preparation Date: | July 06, 2010 | |
|----------------------------|-----------------------------------------------------------------------------------------------------------|--|
| Applicant: | Kimberly Clark Corporation<br>1400 Holcomb Bridge Road<br>Roswell, GA 30097 | |
| Contact Person: | Lester F. Padilla<br>Tel. No.: 678-352-6766 | |
| Trade/Proprietary Name(s): | Kimberly-Clark PURPLE NITRILE* Sterile Powder-Free Exam<br>Gloves - 9.5" Pairs | |
| Common Name(s): | Powder-Free Nitrile Patient Examination Glove (Sterile) | |
| Classification Name: | Patient Examination Glove (21 CFR Part 880.6250),<br>Polymer Patient Examination Glove (Product Code LZA) | |
## Section 5 - 510(k) Summary
### Legally Marketed Device(s) to Which Substantial Equivalence is Claimed:
- Safeskin Sterile PURPLE NITRILE* Examination Gloves (Powder-Free) K992062 1.
- Safeskin PURPLE* Powder-Free Nitrile Examination Gloves for Use with Chemotherapeutic 2. Drugs Labeling Claim - K992162
- 3. Kimberly-Clark Sterling Nitrile & Nitrile Xtra Powder-Free Exam Gloves with Chemotherapy Drug Use Claim - K081089
- 4. Kimberly-Clark Sterling Nitrile Powder-Free Exam Glove - K081027
#### Device Description(s):
Kimberly-Clark PURPLE NITRILE* Sterile Powder-Free Exam Gloves are 9.5-inch long, sterile, purplecolored nitrile, powder-free, ambidextrous patient examination glove that meets all of the requirements of ASTM D 6319-00a, Standard Specification for Nitrile Examination Gloves for Medical Application. The gloves are packaged as two gloves per sterile pouch.
{3}------------------------------------------------
## Traditional 510(k) Notification (Bundled): Kimberly-Clark PURPLE NITRILE* Sterile Powder-Free Exam Gloves - 9.5" Pairs
#### 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.
#### Non-Clinical Testing:
| Characteristics | Applicable<br>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<br>ASTM D 5151-06 | Meets ASTM Requirements |
| Powder Free (Powder Content) | ASTM D 6319-00a<br>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.
{4}------------------------------------------------
#### Traditional 510(k) Notification (Bundled): Kimberly-Clark PURPLE NITRILE* Sterile Powder-Free Exam Gloves - 9.5 Singles
| Preparation Date: | July 06, 2010 |
|----------------------------|-----------------------------------------------------------------------------------------------------------|
| Applicant: | Kimberly Clark Corporation<br>1400 Holcomb Bridge Road<br>Roswell, GA 30097 |
| Contact Person: | Lester F. Padilla<br>Tel. No.: 678-352-6766 |
| Trade/Proprietary Name(s): | Kimberly-Clark PURPLE NITRILE* Sterile Powder-Free Exam<br>Gloves - 9.5" Singles |
| Common Name(s): | Powder-Free Nitrile Patient Examination Glove (Sterile) |
| Classification Name: | Patient Examination Glove (21 CFR Part 880.6250),<br>Polymer Patient Examination Glove (Product Code LZA) |
### Section 5 - 510(k) Summary
#### Legally Marketed Device(s) to Which Substantial Equivalence is Claimed:
- Safeskin Sterile PURPLE NITRILE* Examination Gloves (Powder-Free) K992062 1.
- Safeskin PURPLE* Powder-Free Nitrile Examination Gloves for Use with Chemotherapeutic 2. Drugs Labeling Claim - K992162
- Kimberly-Clark Sterling Nitrile & Nitrile Xtra Powder-Free Exam Gloves with Chemotherapy Drug 3. Use Claim - K081089
- 4. Kimberly-Clark Sterile Sterling Nitrile Powder-Free Exam Glove - K081027
#### Device Description(s):
Kimberly-Clark PURPLE NITRILE* Sterile Powder-Free Exam Gloves are 9.5-inch long, sterile, purplecolored nitrile, powder-free, ambidextrous patient examination glove that meets all of the requirements of ASTM D 6319-00a, Standard Specification for Nitrile Examination Gloves for Medical Application. The gloves are packaged as one glove per sterile bouch.
{5}------------------------------------------------
## Traditional 510(k) Notification (Bundled): Kimberly-Clark PURPLE NITRILE* Sterile Powder-Free Exam Gloves - 9.5 Singles
#### 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.
#### Non-Clinical Testing:
| Characteristics | Applicable Recognized Standards | FDA- | 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<br>ASTM D 5151-06 | | Meets ASTM Requirements |
| Powder Free (Powder Content) | ASTM D 6319-00a<br>ASTM D 6124-06 | | Meets ASTM Requirements |
| ISO Skin Irritation Study and<br>Sensitization | ISO 10993, Part 10 | | Meets ASTM Requirements |
| ISO Cytotoxicity Study | ISO 10993, Part 5 | | |
#### 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.
{6}------------------------------------------------
#### K102032 Traditional 510(k) Notification (Bundled): Kimberly-Clark PURPLE NITRILE-XTRA* Sterile Powder-Free Exam Gloves (Chemotherapy Glove) - 12" Pairs
| Preparation Date: | August 18, 2010 |
|----------------------------|--------------------------------------------------------------------------------------------------------------|
| Applicant: | Kimberly Clark Corporation<br>1400 Holcomb Bridge Road<br>Roswell, GA 30097 |
| Contact Person: | Lester F. Padilla<br>Tel. No .: 678-352-6766 |
| Trade/Proprietary Name(s): | Kimberly-Clark PURPLE NITRILE-XTRA* Sterile Powder-Free<br>Exam Gloves (Chemotherapy Glove) - 12" Pairs |
| Common Name(s): | Powder-Free Nitrile Patient Examination Chemotherapy Use Glove<br>(Sterile) |
| Classification Name: | Patient Examination Glove (21 CFR Part 880.6250),<br>Patient Examination Glove, Specialty (Product Code LZC) |
#### Section 5 - 510(k) Summary
#### Legally Marketed Device(s) to Which Substantial Equivalence is Claimed:
- 1. Safeskin Sterile PURPLE NITRILE* Examination Gloves (Powder-Free) - K992062
- Safeskin PURPLE* Powder-Free Nitrile Examination Gloves for Use with Chemotherapeutic 2. Drugs Labeling Claim - K992162
- Kimberly-Clark Sterling Nitrile Xtra Powder-Free Exam Gloves with Chemotherapy Drug 3. Use Claim - K081089
- Kimberly-Clark Sterling Nitrile Powder-Free Exam Glove K081027 4.
#### Device Description(s):
Kimberly-Clark PURPLE NITRILE-XTRA* Sterile Powder-Free Exam Gloves (Chemotherapy Glove) are 12-inch long, sterile, purple-colored nitrile, powder-free, ambidextrous patient examination glove that meets all of the requirements of ASTM D 6319-00a, Standard Specification for Nitrile Examination Gloves for Medical Application. In addition these gloves were tested for use with the Intended Use(s) section below, per ASTM D6978-05 "Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs." The gloves are packaged as two gloves per sterile pouch.
{7}------------------------------------------------
#### K102032 Traditional 510(k) Notification (Bundled): Kimberly-Clark PURPLE NITRILE-XTRA* Sterile Powder-Free Exam Gloves (Chemotherapy Glove) – 12" Pairs
#### 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:
The following drugs had NO breakthrough detected up to 240 minutes:
| Bleomycin sulfate (15.0mg/ml) | Idarubicin (1.0mg/ml) |
|----------------------------------------|--------------------------------|
| Busulfan (6.0mg/ml) | Ifosfamide (50mg/ml) |
| Carboplatin (10.0mg/ml) | Irinotecan (20.0mg/ml) |
| Cisplatin (1 mg/ml) | Mechlorethamine HCl (1.0mg/ml) |
| Cyclophosphamide (20 mg/ml) | Melphalan (5.0mg/ml) |
| Cytarabine HCl (100.0mg/ml) | Methotrexate (25.0mg/ml) |
| Dacarbazine (10 mg/ml) | Mitomycin (0.5mg/ml) |
| Daunorubicin Hcl (5.0mg/ml) | Mitoxantrone (2 mg/ml) |
| Docetaxel (10.0mg/ml) | Paclitaxel (Taxol) (6 mg/ml) |
| Doxorubicin HCI (Adriamycin) (2 mg/ml) | Paraplatin (10.0mg/ml) |
| Ellence (Epirubicin) (2.0mg/ml) | Rituximab (10.0mg/ml) |
| Etoposide (20 mg/ml) | ThioTEPA (10.0mg/ml) |
| Fludarabine (25.0mg/ml) | Trisenox (0.1mg/ml) |
| Fluorouracil (adrucil) (50 mg/ml) | Vincristine Sulfate (1 mg/ml) |
| Gemcitabine (38.0mg/ml) | |
Please note that the following drug has extremely low permeation times of less than 60 minutes: Carmustine (3.3 mg/ml) 48.6 minutes
#### Summary of Technologies:
The technological characteristics (design, specification, performance) of the Subject Devices and the Predicate Devices are substantially equivalent.
{8}------------------------------------------------
#### K102032 Traditional 510(k) Notification (Bundled): Kimberly-Clark PURPLE NITRILE-XTRA* Sterile Powder-Free Exam Gloves (Chemotherapy Glove) - 12" Pairs
#### Non-Clinical Testing:
| Characteristics | Applicable<br>FDA-<br>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<br>ASTM D 5151-06 | Meets ASTM Requirements |
| Powder Free (Powder Content) | ASTM D 6319-00a<br>ASTM D 6124-06 | Meets ASTM Requirements |
| ISO Skin Irritation Study and<br>Sensitization | ISO 10993, Part 10 | Meets ASTM Requirements |
| ISO Cytotoxicity Study | ISO 10993, Part 5 | Meets ASTM Requirements |
| Resistance to Permeation | ASTM D 6978-05 and/or<br>ASTM F 739-07 | Meets ASTM Requirements<br>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.
{9}------------------------------------------------
Image /page/9/Picture/0 description: The image shows the logo for Kimberly-Clark Corporation. The logo consists of a circular symbol with a stylized cross inside, followed by the company name in a bold, sans-serif font. The text is black, and the overall design is simple and corporate.
### K102032 Traditional 510(k) Notification (Bundled): Kimberly-Clark PURPLE NITRILE* Sterile Powder-Free Exam Gloves (Chemotherapy Glove) - 9.5" Pairs
| Preparation Date: | August 18, 2010 |
|----------------------------|--------------------------------------------------------------------------------------------------------------|
| Applicant: | Kimberly Clark Corporation<br>1400 Holcomb Bridge Road<br>Roswell, GA 30097 |
| Contact Person: | Lester F. Padilla<br>Tel. No .: 678-352-6766 |
| Trade/Proprietary Name(s): | Kimberly-Clark PURPLE NITRILE* Sterile Powder-Free Exam<br>Gloves (Chemotherapy Glove) - 9.5" Pairs |
| Common Name(s): | Powder-Free Nitrile Patient Examination Chemotherapy Use Glove<br>(Sterile) |
| Classification Name: | Patient Examination Glove (21 CFR Part 880.6250),<br>Patient Examination Glove, Specialty (Product Code LZC) |
## Section 5 - 510(k) Summary
#### Legally Marketed Device(s) to Which Substantial Equivalence is Claimed:
- Safeskin Sterile PURPLE NITRILE* Examination Gloves (Powder-Free) K992062 1.
- Safeskin PURPLE* Powder-Free Nitrile Examination Gloves for Use with Chemotherapeutic 2. Drugs Labeling Claim - K992162
- 3. Kimberly-Clark Sterling Nitrile & Nitrile Xtra Powder-Free Exam Gloves with Chemotherapy Drug Use Claim - K081089
- Kimberly-Clark Sterling Nitrile Powder-Free Exam Glove K081027 4.
#### Device Description(s):
. ..
Kimberly-Clark PURPLE NITRILE* Sterile Powder-Free Exam Gloves (Chemotherapy Glove) are 9.5-inch long, sterile, purple-colored nitrile, powder-free, ambidextrous patient examination glove that meets all of the requirements of ASTM D 6319-00a, 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." The gloves are packaged as two gloves per sterile pouch.
{10}------------------------------------------------
#### K102032 Traditional 510(k) Notification (Bundled): Kimberly-Clark PURPLE NITRILE* Sterile Powder-Free Exam Gloves (Chemotherapy Glove) - 9.5" Pairs
#### 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:
| Bleomycin sulfate (15.0mg/ml) | Idarubicin (1.0mg/ml) |
|----------------------------------------|--------------------------------|
| Busulfan (6.0mg/ml) | Ifosfamide (50mg/ml) |
| Carboplatin (10.0mg/ml) | Irinotecan (20.0mg/ml) |
| Cisplatin (1 mg/ml) | Mechlorethamine HCI (1.0mg/ml) |
| Cyclophosphamide (20 mg/ml) | Melphalan (5.0mg/ml) |
| Cytarabine HCl (100.0mg/ml) | Methotrexate (25.0mg/ml) |
| Dacarbazine (10 mg/ml) | Mitomycin (0.5mg/ml) |
| Daunorubicin Hcl (5.0mg/ml) | Mitoxantrone (2 mg/ml) |
| Docetaxel (10.0mg/ml) | Paclitaxel (Taxol) (6 mg/ml) |
| Doxorubicin HCl (Adriamycin) (2 mg/ml) | Paraplatin (10.0mg/ml) |
| Ellence (Epirubicin) (2.0mg/ml) | Rituximab (10.0mg/ml) |
| Etoposide (20 mg/ml) | ThioTEPA (10.0mg/ml) |
| Fludarabine (25.0mg/ml) | Trisenox (0.1mg/ml) |
| Fluorouracil (adrucil) (50 mg/ml) | Vincristine Sulfate (1 mg/ml) |
| Gemcitabine (38.0mg/ml) | |
The following drugs had NO breakthrough detected up to 240 minutes:
Please note that the following drug has extremely low permeation times of less than 60 minutes: Carmustine (3.3 mg/ml) 48.6 minutes
#### Summary of Technologies:
The technological characteristics (design, specification, performance) of the Subject Devices and the Predicate Devices are substantially equivalent.
{11}------------------------------------------------
#### K102032 Traditional 510(k) Notification (Bundled): Kimberly-Clark PURPLE NITRILE* Sterile Powder-Free Exam Gloves (Chemotherapy Glove) - 9.5" Pairs
#### Non-Clinical Testing:
| Characteristics | Applicable<br>FDA-<br>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<br>ASTM D 5151-06 | Meets ASTM Requirements |
| Powder Free (Powder Content) | ASTM D 6319-00a<br>ASTM D 6124-06 | Meets ASTM Requirements |
| ISO Skin Irritation Study and<br>Sensitization<br>ISO Cytotoxicity Study | ISO 10993, Part 10<br>ISO 10993, Part 5 | Meets ASTM Requirements |
| Resistance to Permeation | ASTM D 6978-05 and/or<br>ASTM F 739-07 | Meets ASTM Requirements<br>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.
{12}------------------------------------------------
#### K102032 Traditional 510(k) Notification (Bundled): Kimberly-Clark PURPLE NITRILE* Sterile Powder-Free Exam Gloves (Chemotherapy Glove) - 9.5" Singles
### Preparation Date: August 18, 2010 Kimberly Clark Corporation Applicant: 1400 Holcomb Bridge Road Roswell, GA 30097 Lester F. Padilla Contact Person: Tel. No.: 678-352-6766 Kimberly-Clark PURPLE NITRILE* Sterile Powder-Free Exam Trade/Proprietary Name(s): Gloves (Chemotherapy Glove) - 9.5" Single Powder-Free Nitrile Patient Examination Chemotherapy Use Glove Common Name(s): (Sterile) Patient Examination Glove (21 CFR Part 880.6250), Classification Name: Patient Examination Glove, Specialty (Product Code LZC)
### Section 5 - 510(k) Summary
#### Legally Marketed Device(s) to Which Substantial Equivalence is Claimed:
- Safeskin Sterile PURPLE NITRILE* Examination Gloves (Powder-Free) K992062 l .
- 2. Safeskin PURPLE* Powder-Free Nitrile Examination Gloves for Use with Chemotherapeutic Drugs Labeling Claim - K992162
- Kimberly-Clark Sterling Nitrile Xtra Powder-Free Exam Gloves with Chemotherapy Drug 3. Use Claim - K081089
- Kimberly-Clark Sterling Nitrile Powder-Free Exam Glove K081027 4.
#### Device Description(s):
Kimberly-Clark PURPLE NITRILE* Sterile Powder-Free Exam Gloves (Chemotherapy Glove) are 9.5-inch long, sterile, purple-colored nitrile, powder-free, ambidextrous patient examination glove that meets all of the requirements of ASTM D 6319-00a, Standard Specification for Nitrile Examination Gloves for Medical Application. In addition these gloves were tested for use with the Intended Use(s) section below, per ASTM D6978-05 "Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs." The gloves are packaged as one glove per sterile pouch.
{13}------------------------------------------------
#### K102032 Traditional 510(k) Notification (Bundled): Kimberly-Clark PURPLE NITRILE* Sterile Powder-Free Exam Gloves (Chemotherapy Glove) - 9.5" Singles
#### 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:
The following drugs had NO breakthrough detected up to 240 minutes:
| Bleomycin sulfate (15.0mg/ml) | Idarubicin (1.0mg/ml) |
|----------------------------------------|--------------------------------|
| Busulfan (6.0mg/ml) | Ifosfamide (50mg/ml) |
| Carboplatin (10.0mg/ml) | Irinotecan (20.0mg/ml) |
| Cisplatin (1 mg/ml) | Mechlorethamine HCl (1.0mg/ml) |
| Cyclophosphamide (20 mg/ml) | Melphalan (5.0mg/ml) |
| Cytarabine HCl (100.0mg/ml) | Methotrexate (25.0mg/ml) |
| Dacarbazine (10 mg/ml) | Mitomycin (0.5mg/ml) |
| Daunorubicin Hcl (5.0mg/ml) | Mitoxantrone (2 mg/ml) |
| Docetaxel (10.0mg/ml) | Paclitaxel (Taxol) (6 mg/ml) |
| Doxorubicin HCI (Adriamycin) (2 mg/ml) | Paraplatin (10.0mg/ml) |
| Ellence (Epirubicin) (2.0mg/ml) | Rituximab (10.0mg/ml) |
| Etoposide (20 mg/ml) | ThioTEPA (10.0mg/ml) |
| Fludarabine (25.0mg/ml) | Trisenox (0.1mg/ml) |
| Fluorouracil (adrucil) (50 mg/ml) | Vincristine Sulfate (1 mg/ml) |
| Gemcitabine (38.0mg/ml) | |
Please note that the following drug has extremely low permeation times of less than 60 minutes: Carmustine (3.3 mg/ml) 48.6 minutes
#### Summary of Technologies:
The technological characteristics (design, specification, performance) of the Subject Devices and the Predicate Devices are substantially equivalent.
{14}------------------------------------------------
Image /page/14/Picture/0 description: The image shows the logo of Kimberly-Clark Corporation. The logo consists of a circular symbol with a stylized cross inside, followed by the company name in a bold, sans-serif font. The text is all in black, and the logo appears to be a vector graphic.
#### K102032 Traditional 510(k) Notification (Bundled): Kimberly-Clark PURPLE NITRILE* Sterile Powder-Free Exam Gloves (Chemotherapy Glove) - 9.5" Singles
#### Non-Clinical Testing:
| Characteristics | Applicable<br>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<br>ASTM D 5151-06 | Meets ASTM Requirements |
| Powder Free (Powder Content) | ASTM D 6319-00a<br>ASTM D 6124-06 | Meets ASTM Requirements |
| ISO Skin Irritation Study and<br>Sensitization | ISO 10993, Part 10 | Meets ASTM Requirements |
| ISO Cytotoxicity Study | ISO 10993, Part 5 | Meets ASTM Requirements |
| Resistance to Permeation | ASTM D 6978-05 and/or<br>ASTM F 739-07 | Meets ASTM Requirements<br>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.
{15}------------------------------------------------
Image /page/15/Picture/0 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" around the perimeter. Inside the circle is a stylized graphic of three human figures, represented by flowing lines, symbolizing health and well-being.
## DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
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 Divine Responsible Third Party Official Underwriters Laboratories, Incorporated 333 Pfingsten Road Northbrook, Illinois 60062
SEP 0 8 2010
Re: K102032
Trade/Device Name: Kimberly-Clark Purple NITRILE-XTRA "Sterile Powder-Free
Examination Glove with Tested For Use with Chemotherapy Drug Labeling Claim (12"Pairs)
Labeling Claim (12"Pairs).
Kimberly-Clark Purple NITRILE Sterile Powder-Free Examination Glove with Tested For Use with Chemotherapy Labeling Claim (9.5"Pairs)
Kimberly-Clark Purple NITRILE Sterile Powder Free Examination Glove with Tested For Use with Chemotherapy Drug Labeling Claim (9.5"Single)
Kimberly-Clark Purple NITRILE-XTRA Sterile Powder-Free Examination Glove (12"Pairs)
Kimberly-Clark Purple NITRILE Sterile Powder-Free Examination Glove (9.5"Pairs)
Kimberly-Clark Purple NITRILE Sterile Powder-Free Examination Glove (9.5"Single)
Regulation Number: 21 CFR 880.6250
Regulation Name: Patient Examination Glove
Regulatory Class: I
Product Code: LZA, LZC .
Dated: August 18, 2010
Received: August 20, 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.
{16}------------------------------------------------
#### Page 2- Mr. Devine
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 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.
{17}------------------------------------------------
Page 3- Mr. Devine
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
(-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-
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
{18}------------------------------------------------
## Indications for Use
510(k) Number (if known): K102032
Device Name(s):
Kimberly-Clark PURPLE NITRILE-XTRA* Sterile Powder-Free Exam Glove (Chemotherapy Glove) - 12" Pairs
#### 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) | Idarubicin (1.0mg/ml) |
|----------------------------------------|--------------------------------|
| Busulfan (6.0mg/ml) | Ifosfamide (50mg/ml) |
| Carboplatin (10.0mg/ml) | Irinotecan (20.0mg/ml) |
| Cisplatin (1 mg/ml) | Mechlorethamine HCl (1.0mg/ml) |
| Cyclophosphamide (20 mg/ml) | Melphalan (5.0mg/ml) |
| Cytarabine HCl (100.0mg/ml) | Methotrexate (25.0mg/ml) |
| Dacarbazine (10 mg/ml) | Mitomycin (0.5mg/ml) |
| Daunorubicin Hcl (5.0mg/ml) | Mitoxantrone (2 mg/ml) |
| Docetaxel (10.0mg/ml) | Paclitaxel (Taxol) (6 mg/ml) |
| Doxorubicin HCl (Adriamycin) (2 mg/ml) | Paraplatin (10.0mg/ml) |
| Ellence (Epirubicin) (2.0mg/ml) | Rituximab (10.0mg/ml) |
| Etoposide (20 mg/ml) | ThioTEPA (10.0mg/ml) |
| Fludarabine (25.0mg/ml) | Trisenox (0.1mg/ml) |
| Fluorouracil (adrucil) (50 mg/ml) | Vincristine Sulfate (1 mg/ml) |
| Gemcitabine (38.0mg/ml) | |
Please note that the following drug has extremely low permeation times of less than 60 minutes: Carmustine (3.3 mg/ml) 48.6 minutes
Page 1 of 2
Elizabeth St. Claire-Will
(Division Sian-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
. . . .
{19}------------------------------------------------
## Indications for Use (cont'd)
510(k) Number (if known): K102032
Device Name(s):
Kimberly-Clark PURPLE NITRILE-XTRA* Sterile Powder-Free Exam Glove (Chemotherapy Glove) – 12" Sterile Pairs
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_
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K | O2032
{20}------------------------------------------------
### Indications for Use
510(k) Number (if known): K102032
Device Name(s):
Kimberly-Clark PURPLE NITRILE* Sterile Powder-Free Exam Glove (Chemotherapy Glove) - 9.5" Pairs
#### 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) | Idarubicin (1.0mg/ml) |
|----------------------------------------|--------------------------------|
| Busulfan (6.0mg/ml) | Ifosfamide (50mg/ml) |
| Carboplatin (10.0mg/ml) | Irinotecan (20.0mg/ml) |
| Cisplatin (1 mg/ml) | Mechlorethamine HCl (1.0mg/ml) |
| Cyclophosphamide (20 mg/ml) | Melphalan (5.0mg/ml) |
| Cytarabine HCl (100.0mg/ml) | Methotrexate (25.0mg/ml) |
| Dacarbazine (10 mg/ml) | Mitomycin (0.5mg/ml) |
| Daunorubicin HCl (5.0mg/ml) | Mitoxantrone (2 mg/ml) |
| Docetaxel (10.0mg/ml) | Paclitaxel (Taxol) (6 mg/ml) |
| Doxorubicin HCl (Adriamycin) (2 mg/ml) | Paraplatin (10.0mg/ml) |
| Ellence (Epirubicin) (2.0mg/ml) | Rituximab (10.0mg/ml) |
| Etoposide (20 mg/ml) | ThioTEPA (10.0mg/ml) |
| Fludarabine (25.0mg/ml) | Trisenox (0.1mg/ml) |
| Fluorouracil (adrucil) (50 mg/ml) | Vincristine Sulfate (1 mg/ml) |
| Gemcitabine (38.0mg/ml) | |
Please note that the following drug has extremely low permeation times of less than 60 minutes: Carmustine (3.3 mg/ml) 48.6 minutes
Page 1 of 2
Elita I Clanto-Wille
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K1102032
{21}------------------------------------------------
## Indications for Use (cont'd)
510(k) Number (if known): K102032
Device Name(s):
Kimberly-Clark PURPLE NITRILE* Sterile Powder-Free Exam Glove (Chemotherapy Glove) - 9.5" Sterile Pairs
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)
Page _2_ of _2_
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: _K 102032
{22}------------------------------------------------
### Indications for Use
510(k) Number (if known): K102032
Device Name(s):
Kimberly-Clark PURPLE NITRILE* Sterile Powder-Free Exam Glove (Chemotherapy Glove) -- 9.5" Singles
#### 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) | Idarubicin (1.0mg/ml) |
|----------------------------------------|--------------------------------|
| Busulfan (6.0mg/ml) | Ifosfamide (50mg/ml) |
| Carboplatin (10.0mg/ml) | Irinotecan (20.0mg/ml) |
| Cisplatin (1 mg/ml) | Mechlorethamine HCl (1.0mg/ml) |
| Cyclophosphamide (20 mg/ml) | Melphalan (5.0mg/ml) |
| Cytarabine HCl (100.0mg/ml) | Methotrexate (25.0mg/ml) |
| Dacarbazine (10 mg/ml) | Mitomycin (0.5mg/ml) |
| Daunorubicin Hcl (5.0mg/ml) | Mitoxantrone (2 mg/ml) |
| Docetaxel (10.0mg/ml) | Paclitaxel (Taxol) (6 mg/ml) |
| Doxorubicin HCl (Adriamycin) (2 mg/ml) | Paraplatin (10.0mg/ml) |
| Ellence (Epirubicin) (2.0mg/ml) | Rituximab (10.0mg/ml) |
| Etoposide (20 mg/ml) | ThioTEPA (10.0mg/ml) |
| Fludarabine (25.0mg/ml) | Trisenox (0.1mg/ml) |
| Fluorouracil (adrucil) (50 mg/ml) | Vincristine Sulfate (1 mg/ml) |
| Gemcitabine (38.0mg/ml) | |
Please note that the following drug has extremely low permeation times of less than 60 minutes: Carmustine (3.3 mg/ml) 48.6 minutes
Page 1 of 2
Elyatt P. Laurent-Well
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Nur
{23}------------------------------------------------
Image /page/23/Picture/0 description: The image shows the logo for Kimberly-Clark Corporation. The logo consists of a circular symbol with a stylized cross inside, followed by the company name in bold, sans-serif font. The text is black, and the overall design is simple and corporate.
## Indications for Use (cont'd)
510(k) Number (if known): K102032
Device Name(s):
Kimberly-Clark PURPLE NITRILE* Sterile Powder-Free Exam Glove (Chemotherapy Glove) - 9.5" Sterile Single
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)
Page 2 of 2_
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: _ K/62032
{24}------------------------------------------------
## Indications for Use
510(k) Number (if known): K102032
Device Name(s):
Kimberly-Clark PURPLE NITRILE-XTRA* Sterile Powder-Free Exam Glove (12" Pairs)
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
Elijabeth P. Claveria-Wilber
(Division Sign-Off) (Division Sign-on)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Reviens Division of Antool, Dental Devices
510(k) Number: K102032
{25}------------------------------------------------
## ද්යා Kimberly-Clark Corporation
## Indications for Use
510(k) Number (if known): K | 02032
## Device Name(s):
Kimberly-Clark PURPLE NITRILE* Sterile Powder-Free Exam Glove (9.5" Pairs)
## 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 (Division Sign-Off)
(Division Sign-On)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K70 2032
{26}------------------------------------------------
Image /page/26/Picture/0 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, with "Kimberly-Clark" being larger than "Corporation". The overall design is simple and professional.
## Indications for Use
510(k) Number (if known): K | 02032
### Device Name(s):
Kimberly-Clark PURPLE NITRILE* Sterile Powder-Free Exam Glove (9.5" Singles)
### 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
Edith P. Clauss-Willis
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K102032
