← Product Code [KGO](/submissions/SU/subpart-e%E2%80%94surgical-devices/KGO) · K153316 # Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating and Tested for Use with Chemotherapy Drugs (Yellow) (K153316) _Cardinal Health, Inc. · KGO · May 12, 2016 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/KGO/K153316 ## Device Facts - **Applicant:** Cardinal Health, Inc. - **Product Code:** [KGO](/submissions/SU/subpart-e%E2%80%94surgical-devices/KGO.md) - **Decision Date:** May 12, 2016 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4460 - **Device Class:** Class 1 - **Review Panel:** General, Plastic Surgery ## Intended Use A powder-free sterile surgeon's glove is a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs: ## Device Story Disposable, sterile, powder-free surgical glove; synthetic neoprene polymer with nitrile coating; yellow color. Features include anti-slip finish, independent thumb, and mechanically locking cuffs to prevent roll-down. Used by operating room personnel to protect surgical wounds from contamination. Tested for permeation resistance against 11 chemotherapy drugs per ASTM D6978. Provides barrier protection; healthcare providers wear gloves during surgical procedures to maintain sterile fields and protect against chemical exposure. ## Clinical Evidence No clinical data. Bench testing only. Performance verified via ASTM D3577 (physical properties, dimensions, freedom from holes, powder residual) and ASTM D6978 (chemotherapy drug permeation). Biocompatibility confirmed via ISO 10993-10 (non-irritating, non-sensitizing). ## Technological Characteristics Synthetic neoprene polymer with nitrile coating; hand-specific design with independent thumb and beaded cuff. Meets ASTM D3577 for physical properties and dimensions. Freedom from holes meets 21 CFR 800.20 and ASTM D3577 (AQL 1.5). Powder residual ≤2.0 mg/glove. Sterile, single-use. ## Regulatory Identification A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing. ## Predicate Devices - Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating Tested for Use with Chemotherapy Drugs ([K113707](/device/K113707.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 an abstract symbol that resembles a stylized caduceus or a series of interconnected human profiles. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 12, 2016 Cardinal Health 200, LLC. Ms. Megan Middaugh Manager, Regulatory Affairs 1500 Waukegan Road Waukegan, Illinois 60085 Re: K153316 Trade/Device Name: Cardinal Health™ Sterile Neoprene Powder-free Surgical Gloves with Nitrile Coating and Tested for Use with Chemotherapy Drugs (Yellow) Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO, LZC Dated: April 15. 2016 Received: April 18, 2016 Dear Ms. Megan Middaugh: 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 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 {1}------------------------------------------------ Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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. *Tejashri Purohit-Sheth, M.D.* Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use #### 510(k) Number (if known) K153316 #### Device Name Cardinal Health™ Sterile Neoprene Powder-free Surgical Gloves with Nitrile Coating and Tested for Use with Chemotherapy Drugs (Yellow) #### Indications for Use (Describe) A powder-free sterile surgeon's glove is a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs: | | Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time
0.01 µg/cm²/minute | |-----|-------------------------------------|-----------------------------------------------------------| | 1. | Carmustine (BCNU) (3.3 mg/ml) | 60.1 | | 2. | Cisplastin, (1.0 mg/ml) | >240 | | 3. | Cyclophosphamide (20 mg/ml) | >240 | | 4. | Doxorubicin HCl (2.0 mg/ml) | >240 | | 5. | Etoposide (Toposar) (20 mg/ml) | >240 | | 6. | Fluorouracil (50 mg/ml) | >240 | | 7. | Methotrexate (25 mg/ml) | >240 | | 8. | Mitomycin C (0.5 mg/ml) | >240 | | 9. | Paclitaxel (Taxol) (6.0 mg/ml) | >240 | | 10. | Thiotepa (10 mg/ml) | 110.5 | | 11. | Vincristine Sulfate(1 mg/ml) | >240 | CAUTION: Testing showed an average breakthrough time of 60.1 minutes with Carmustine Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) X Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. {3}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ Image /page/4/Picture/0 description: The image contains the logo for Cardinal Health. The logo consists of a stylized red bird-like design above the company name. The text "CardinalHealth" is written in a bold, sans-serif font, with the first letter of each word capitalized. Cardinal Health 1500 Waukegan Road Waukegan, IL 60085 cardinalhealth.com Page _1_ of _6_ ## 510(k) SUMMARY ### K153316 ## Cardinal Health™ Sterile Neoprene Powder-free Surgical Gloves with Nitrile Coating and Tested for Use with Chemotherapy Drugs (Yellow) | Manufacturer: | Cardinal Health 200, LLC
1500 Waukegan Road
Waukegan, IL 60085 | |-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------| | Regulatory Affairs Contact: | Megan Middaugh
1500 Waukegan Road
Waukegan, IL 60085 | | Telephone Number: | (847) 887-6812 | | Fax Number: | (847) 887-2461 | | Date Summary Prepared: | April 15, 2016 | | Product Trade Name: | Cardinal Health™ Sterile Neoprene Powder-free Surgical Gloves
with Nitrile Coating and Tested for Use with Chemotherapy Drug
(Yellow) | | Common Name: | Surgeon's Gloves | | Classification Name: | Surgeon's Gloves | | Classification Panel: | General and Plastic Surgery | | Regulation: | 21 CFR 878.4460 | | Product Code: | KGO | | Subsequent Product Code: | LZC | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Cardinal Health. The logo consists of a stylized red graphic above the company name. The graphic is composed of several curved lines that resemble a bird in flight. The text "CardinalHealth" is written in a bold, sans-serif font. Page _2_ of_ _6_ | Predicate Devices: | K113707 - Sterile Neoprene Powder-Free Surgical Gloves with
Nitrile Coating Tested for Use with Chemotherapy Drugs | |----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Reason for 510(k)
Submission: | New device | | Device Description: | The proposed device is a disposable device. It is not made with
natural rubber latex. Instead, the gloves are formulated using
neoprene synthetic polymer and are coated with nitrile coating and
is yellow in color.

The glove are manufactured using molds that feature anti-slip
finish, independent thumb and mechanically locking cuffs to help
prevent cuff roll down. They are offered powder-free and sterile.
This glove is for single use only. | | Intended Use: | A powder-free sterile surgeon's glove is a disposable device
made of synthetic rubber intended to be worn by operating room
personnel to protect a surgical wound from contamination.

In addition, these gloves were tested for use with chemotherapy
drugs in accordance with ASTM D6978 Standard Practice for
Assessment of Medical Gloves to Permeation by Chemotherapy
Drugs: | {6}------------------------------------------------ ## Table 1: Chemotherapy Drug Permeation Time | | Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time 0.01 µg/cm²/minute | |-----|-------------------------------------|--------------------------------------------------------| | 1. | Carmustine (BCNU) (3.3 mg/ml) | 60.1 | | 2. | Cisplastin, (1.0 mg/ml) | >240 | | 3. | Cyclophosphamide (20 mg/ml) | >240 | | 4. | Doxorubicin HCl (2.0 mg/ml) | >240 | | 5. | Etoposide (Toposar) (20 mg/ml) | >240 | | 6. | Fluorouracil (50 mg/ml) | >240 | | 7. | Methotrexate (25 mg/ml) | >240 | | 8. | Mitomycin C (0.5 mg/ml) | >240 | | 9. | Paclitaxel (Taxol) (6.0 mg/ml) | >240 | | 10. | Thiotepa (10 mg/ml) | 110.5 | | 11. | Vincristine Sulfate (1 mg/ml) | >240 | CAUTION: Testing showed an average breakthrough time of 60.1 minutes with Carmustine Substantial Equivalence: The proposed device is substantially equivalent to the predicate device identified in this 510(k) summary. Substantial equivalence can be established in regard to intended use, physical properties and characteristics, design and product features. Both gloves are made of synthetic neoprene using similar manufacturing process. {7}------------------------------------------------ | Table 2: Summary of Technological Characteristics | | | |---------------------------------------------------|--|--| | | | | | Summary of the technological characteristics of the device compared to the predicate device | | | |----------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Characteristic | New Device | Predicate Device | | Material Composition | Synthetic Neoprene Polymer coated
with Nitrile | Synthetic Neoprene Polymer coated
with Nitrile | | Design | Hand Specific
Independent Thumb
Beaded Cuff
Lubricated | Hand Specific
Independent Thumb
Beaded Cuff
Lubricated | | Intended Use | A powder-free sterile surgeon's glove is
a disposable device made of synthetic
rubber intended to be worn by operating
room personnel to protect a surgical
wound from contamination. | These powder-free sterile light brown
colored surgeon's gloves are a
disposable device made of synthetic
rubber intended to be worn by
operating room personnel to protect a
surgical wound from contamination. | | Indications for Use | In addition, these gloves were tested for
use with chemotherapy drugs in
accordance with ASTM D6978
Standard Practice for Assessment of
Medical Gloves to Permeation by
Chemotherapy Drugs. | In addition, these gloves were tested
for use with chemotherapy drugs in
accordance with ASTM D6978
Standard Practice for Assessment of
Medical Gloves to Permeation by
Chemotherapy Drugs. | | Label Claims | Sterile
Powder-free
Neoprene Surgical Glove with Nitrile
Coating
Not made with natural rubber latex
For Single Use Only
Tested for Use with Chemotherapy
Drugs
AQL 0.65 | Sterile
Powder-free
Neoprene Surgical Glove with Nitrile
Coating
Not made with natural rubber latex
For Single Use Only
Tested for Use with Chemotherapy
Drugs
AQL 1.0 | | Dimensions & Physical
Properties | Meets ASTM D3577 | Meets ASTM D3577 | | Freedom from Holes | Meets 21CFR 800.20 & ASTM D3577
requirements of AQL 1.5 | Meets 21CFR 800.20 & ASTM
D3577 requirements of AQL 1.5 | | Powder Residual | Meets requirements of ≤2.0 mg/glove
for Powder-Free designation per ASTM
D3577 | Meets requirements of ≤2.0 mg/glove
for Powder-Free designation per
ASTM D3577 | | Biocompatibility
(Irritation, ISO 10993-
0:2010; Sensitization, ISO
10993-10: 2010) | Non-Irritating, under the conditions of
the study
Non-sensitizing, under the conditions of
the study | Non-Irritating, under the conditions
of the study
Non-sensitizing, under the conditions
of the study | | Characteristic | Cardinal Health™ Sterile Neoprene
Powder-free Surgical Gloves with
Nitrile Coating and Tested for Use with
Chemotherapy Drugs (Yellow)
(K153316) | Sterile Neoprene Powder-Free
Surgical Glove w/Chemo Claim
(K113707) | {8}------------------------------------------------ # Table 3: Summary of Non-Clinical Tests | PERFORMANCE DATA | | | |-----------------------------------------------------------------------------------------|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION
OF SUBSTANTIAL EQUIVALENCE | | | | Performance Test Summary-New Device | | | | Characteristic | Standard/Test/FDA
Guidance | Results Summary | | Biocompatibility: | | | | Primary Skin
Irritation | ISO 10993-10 | Non-Irritating, under the conditions of the
study | | Guinea Pig
Maximization | ISO 10993-10 | Non-sensitizing, under the conditions of the
study | | Physical Characteristics: | | | | Dimensions | ASTM D3577 | Meets requirements | | Physical Properties | ASTM D3577 | Meet requirements for synthetic surgical
gloves | | Freedom from Holes | 21 CFR 800.20 &
ASTM D3577 | Tested in accordance with ASTM D 5151
and meets 21CFR 800.20 & ASTM
D3577 requirements of AQL 1.5 | | Powder Residual | ASTM D3577 tested
using ASTM
standard D6124 | Gloves meet powder level requirements for
"Powder-Free" designation per ASTM
D3577. Results generated values < 2mg of
residual powder per glove. | | Chemotherapy Drug
Permeation | ASTM D 6978 | Gloves were tested using ASTM D6978.
Under the test conditions prescribed by the
test, the minimum normalized breakthrough
detection times for each of the chemotherapy
drugs tested exceeded the maximum testing
time of 240 minutes except for Carmustine
(BCNU) (3.3 mg/ml), which showed
permeation time of 60.1 minutes, and
Thiotepa (10 mg/ml), which showed
permeation time of 110.5 minutes | {9}------------------------------------------------ ## Page_6_of_6 ### Table 4: Summary of Comparative Performance | Comparative Performance Information Summary | | | | |---------------------------------------------|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Characteristic | Requirement | New Device | Predicate Device | | Biocompatibility: | ISO 10993-1 | Meets requirements | Meets requirements | | Primary Skin Irritation | ISO 10993-10 | Non-Irritating, under the conditions of the study | Non-Irritating, under the conditions of the study | | Guinea Pig Maximization | ISO 10993-10 | Non-sensitizing, under the conditions of the study | Non-sensitizing, under the conditions of the study | | Dimensions | ASTM D3577 | Meets requirements | Meets requirements | | Physical Properties | ASTM D3577 | Meets requirements | Meets requirements | | Freedom from Holes | 21CFR800.20, ASTM D3577 | Meets requirements | Meets requirements | | Powder Residual | ASTM D3577 | Meets requirements | Meets requirements | | Chemotherapy Drug Permeation | ASTM D6978 | Under the test conditions prescribed by the test, the minimum normalized breakthrough detection times for each of the 11 chemotherapy drugs tested exceeded the maximum testing time of 240 minutes except for Carmustine (BCNU) (3.3 mg/ml), which showed permeation time of 60.1 minutes, and Thiotepa (10 mg/ml), which showed permeation time of 110.5 minutes. | Under the test conditions prescribed by the test, the minimum normalized breakthrough detection times for each of the 10 chemotherapy drugs tested exceeded the maximum testing time of 240 minutes except for Carmustine (BCNU) (3.3 mg/ml), which showed permeation time of 0.20 minutes, and Thiotepa (10 mg/ml), which showed permeation time of 82.2 minutes. | ### CAL TESTS CONDUCTED FOR SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION Clinical data is not required. # CONCLUSIONS DRAWN FROM NON-CLINICAL DATA Non-clinical data demonstrates Cardinal Health™ Sterile Neoprene Powder-free Surgical Gloves with Nitrile Coating and Tested for Use with Chemotherapy Drugs (Yellow) meet the technological characteristics of ASTM D3577 standard, and are as safe, as effective, and performed as well as the legally marketed devices identified in this summary. --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/KGO/K153316](https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/KGO/K153316) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com