Powder-free Nitrile Patient Examination Glove, Green Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs

Q: Who is the manufacturer of Powder-free Nitrile Patient Examination Glove, Green Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs?

Semperit Investments Asia Pte , Ltd. filed the 510(k) submission for Powder-free Nitrile Patient Examination Glove, Green Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs (K183441).

Q: What is the FDA product code for Powder-free Nitrile Patient Examination Glove, Green Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs?

LZA. It is classified under 21 CFR 880.6250 as a Class 1 device in the General Hospital panel.

Q: What is the regulatory pathway for Powder-free Nitrile Patient Examination Glove, Green Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs?

510(k) clearance (submission type: Traditional).

Q: What are the predicate devices for Powder-free Nitrile Patient Examination Glove, Green Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs?

Powder Free Nitrile Patient Examination Glove (K151824).

Q: Who can help prepare an FDA 510(k) submission like Powder-free Nitrile Patient Examination Glove, Green Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K183441 · Semperit Investments Asia Pte , Ltd. · LZA · Oct 4, 2019 · General Hospital

Device Facts

Record ID	K183441
Device Name	Powder-free Nitrile Patient Examination Glove, Green Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs
Applicant	Semperit Investments Asia Pte , Ltd.
Product Code	LZA · General Hospital
Decision Date	Oct 4, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.6250
Device Class	Class 1

Indications for Use

This device is an ambidextrous patient examination glove that is non-sterile, single use, disposable device intended for medical purposes, worn on the examiner's hand to prevent contamination between patient and examiner. The glove was tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs listed below

Device Story

Ambidextrous, non-sterile, single-use nitrile examination glove; worn by healthcare providers to prevent cross-contamination. Tested for permeation resistance against 15 chemotherapy drugs per ASTM D6978-05. Provides barrier protection in clinical settings. Not for use with Carmustine or Thiotepa due to low breakthrough times. Benefits include reduced risk of patient-examiner contamination and protection during chemotherapy drug handling.

Clinical Evidence

Bench testing only. No clinical data. Testing included: dimensions (ASTM D3767-03), tensile strength (ASTM D412-16), residual powder (ASTM D6124-06), water leak (ASTM D5151-06), chemotherapy drug permeation (ASTM D6978-05), and biocompatibility (ANSI/AAMI/ISO 10993-5 and ISO 10993-10).

Technological Characteristics

Nitrile material; ambidextrous; non-sterile; disposable. Complies with ASTM D6319-10, D5151-06, D6124-06, D6978-05, D412-16, D3767-03. Biocompatibility per ISO 10993-5 (cytotoxicity) and ISO 10993-10 (sensitization/irritation). Available in XS, S, M, L, XL sizes. Packaged in dispenser boxes.

Indications for Use

Indicated for use as a non-sterile, single-use, disposable, ambidextrous patient examination glove worn by medical personnel to prevent cross-contamination between patient and examiner. Suitable for use with specific chemotherapy drugs, excluding Carmustine and Thiotepa.

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

Powder Free Nitrile Patient Examination Glove (K151824)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters. October 4, 2019 Semperit Investments Asia PTE LTD. % Jay Mansour Principal Mansour Consulting LLC 845 Aronson Lake Court Roswell, Georgia 30075 Re: K183441 Trade/Device Name: Powder-free Nitrile Patient Examination Glove, Green Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I Product Code: LZA, LZC Dated: August 29, 2019 Received: September 3, 2019 Dear Jay Mansour: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. {1}------------------------------------------------ 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. For Elizabeth Claverie, M.S. Assistant Director for THT4B2 Acting Assistant Director for THT4B1 DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K183441 #### Device Name Powder-free Nitrile Patient Examination Glove, Green Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs #### Indications for Use (Describe) This device is an ambidextrous patient examination glove that is non-sterile, single use, disposable device intended for medical purposes, worn on the examiner's hand to prevent contamination between patient and examiner. The glove was tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs listed below | | Minimum Breakthrough detection time (minutes) | |-----------------------------------------|-----------------------------------------------| | Carmustine (BCNU) (3.3 mg/ml) | 15.9 | | Cisplatin (1.0 mg/ml) | >240 | | Cyclophosphamide (Cytoxan) (20.0 mg/ml) | >240 | | Cytarabine (100mg/ml) | >240 | | Dacarbazine (DTIC) (10.0 mg/ml) | >240 | | Doxorubicin Hydrochloride (2.0 mg/ml) | >240 | | Etoposide (20.0 mg/ml) | >240 | | Fluorouracil (50.0 mg/ml) | >240 | | Ifosfamide (50.0 mg/ml) | >240 | | Methotrexate (25.0 mg/ml) | >240 | | Mitomycin C (0.5 mg/ml) | >240 | | Mitoxantrone (2.0 mg/ml) | >240 | | Paclitaxel (Taxol) (6.0 mg/ml) | >240 | | Thiotepa (10.0 mg/ml) | 11.1 | | Vincristine Sulfate (1.0 mg/ml) | >240 | Do not use with Carmustine and Thiotepa. Please note that the following drugs have extremely low permeation times: Carmustine (BCNU): 15.9 minutes and Thiotepa:11.1 minutes. 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. 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." {3}------------------------------------------------ # 510(k) # K183441 # 510k Summary ### As required by 21 CFR 807.92 ### 1- Date summary prepared: September 26, 2019 #### Owner/Submitter/Sponsor/Applicant information: 2- SEMPERIT INVESTMENTS ASIA PTE. LTD. 8 Jurong Town Hall Road, #29-03 To 06 The JTC Summit Singapore 609434 Contact person Name: Jay Mansour, MSQA, BE, RAC Title: regulatory consultant- Mansour Consulting LLC – Principal Phone: (678) 908-8180 Email address: jay@mansourconsulting.com - 3- Device information: Common/usual/classification name: Powder-Free Nitrile Patient Examination Glove Device name: Powder-free Nitrile Patient Examination Glove, Green colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs | FDA 3 letter code | LZA, LZC | |-------------------------------|------------------| | FDA regulation number: 21 CFR | 880.6250 | | Regulation medical specialty | General Hospital | | Review panel | General Hospital | | Class | I | #### 4- Predicate device: | 510k number | Trade or Proprietary or Model Name | Manufacturer | |-------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------| | K151824 | --Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential, and Tested for use with Chemotherapy Drugs --Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Low Dermatitis Potential, and Tested for use with Chemotherapy Drugs | KOSSAN INTERNATIONAL SDN. BHD. | #### 5- Description of the device: {4}------------------------------------------------ The Powder-free Nitrile Patient Examination Glove, Green Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs meets all the requirements of ASTM standard D6319-10. It is an ambidextrous medical glove, which is a disposable device, provided in x-small, medium, large and xlarge sizes. In addition, these gloves were tested for use with chemotherapy drugs per ASTM D6978-05 "Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drug," and Modified-Draize-95 Test, per FDA guidance document "Guidance for Industry and FDA Reviewers/Staff: Premarket Notification [510(k)] Submissions for Testing for Skin Sensitization to Chemicals in Natural Rubber Products," 1999. - 6- Indications for use This device is an ambidextrous patient examination glove that is non-sterile, single use, disposable device intended for medical purposes, worn on the examiner's hand to prevent contamination between patient and examiner. The glove was tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs listed below | Carmustine (BCNU) (3.3 mg/ml) | 15.9 | |-----------------------------------------|------| | Cisplatin (1.0 mg/ml) | >240 | | Cyclophosphamide (Cytoxan) (20.0 mg/ml) | >240 | | Cytarabine (100mg/ml) | >240 | | Dacarbazine (DTIC) (10.0 mg/ml) | >240 | | Doxorubicin Hydrochloride (2.0 mg/ml) | >240 | | Etoposide (20.0 mg/ml) | >240 | | Fluorouracil (50.0 mg/ml) | >240 | | Ifosfamide (50.0 mg/ml) | >240 | | Methotrexate (25.0 mg/ml) | >240 | | Mitomycin C (0.5 mg/ml) | >240 | | Mitoxantrone (2.0 mg/ml) | >240 | | Paclitaxel (Taxol) (6.0 mg/ml) | >240 | | Thiotepa (10.0 mg/ml) | 11.1 | | Vincristine Sulfate (1.0 mg/ml) | >240 | Minimum Breakthrough detection time (minutes) {5}------------------------------------------------ Do not use with Carmustine and Thiotepa. Please note that the following drugs have extremely low permeation times: Carmustine (BCNU): 15.9 minutes and Thiotepa:11.1 minutes. # 7- Technological Characteristics: Shown below is the technological characteristics comparison of the subject device and the predicate device. | | Subject device | | Predicate Device | Comments | |--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | SEMPERIT INVESTMENTS ASIA PTE. LTD. | | KOSSAN INTERNATIONAL SDN. BHD. | N/A | | 510(k) number | K183441 | | K151824 | N/A | | Device trade or proprietary name | Powder-free Nitrile Patient Examination Glove, Green Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs | | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential, and Tested for use with Chemotherapy Drugs Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Low Dermatitis Potential, and Tested for use with Chemotherapy Drugs | Identical, except that subject device is in green, while predicate device is in blue or white. | | Device Classification Name/ Regulation number | Patient Examination Glove 21 CFR Part 880.6250 | | Patient Examination Glove 21 CFR Part 880.6250 | Identical | | Product Code | LZA, LZC | | LZA, LZC | Identical | | Intended Use | This device is an ambidextrous patient examination glove that is a non-sterile, single use, disposable device intended for medical purposes, worn on the examiner's hand to prevent contamination between patient and examiner. The tested chemotherapy drugs are: | | A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The tested chemotherapy drugs are: | Identical, except for lower breakthrough time for Thiotepa. (Both devices are ambidextrous) | | | CARMUSTINE (BCNU) 3.3 MG/ML CISPLATIN 1.0 MG/ML CYCLOPHOSPHAMIDE (CYTOXAN) 20.0 MG/ML CYTARABINE 100 MG/ML DACARBAZINE (DTIC) 10.0 MG/ML DOXORUBICIN HYDROCHLORIDE 2.0 MG/ML | extremely low permeation times of 15.9 minutes. no breakthrough up to 240 minutes no breakthrough up to 240 minutes no breakthrough up to 240 minutes no breakthrough up to 240 minutes no breakthrough up to 240 minutes | CARMUSTINE (BCNU) 3.3 MG/ML CISPLATIN 1.0 MG/ML CYCLOPHOSPHAMIDE (CYTOXAN) 20.0 MG/ML CYTARABINE 100 MG/ML DACARBAZINE (DTIC) 10.0 MG/ML DOXORUBICIN HYDROCHLORIDE 2.0 MG/ML | extremely low permeation times of 10.4 minutes. no breakthrough up to 240 minutes no breakthrough up to 240 minutes no breakthrough up to 240 minutes no breakthrough up to 240 minutes no breakthrough up to 240 minutes | {6}------------------------------------------------ | | ETOPOSIDE 20.0 MG/ML FLUOROURACIL 50.0 MG/ML IFOSFAMIDE 50.0 MG/ML METHOTREXATE 25.0 MG/ML MITOMYCIN C 0.5 MG/ML MITOXANTRONE 2.0 MG/ML PACLITAXEL (TAXOL) 6.0 MG/ML THIOTEPA 10.0 MG/ML VINCRISTINE SULFATE 1.0 MG/ML | no breakthrough up to 240 minutes no breakthrough up to 240 minutes no breakthrough up to 240 minutes no breakthrough up to 240 minutes no breakthrough up to 240 minutes no breakthrough up to 240 minutes no breakthrough up to 240 minutes extremely low permeation times of 11.1 minutes no breakthrough up to 240 minutes | | ETOPOSIDE 20.0 MG/ML FLUOROURACIL 50.0 MG/ML IFOSFAMIDE 50.0 MG/ML METHOTREXATE 25.0 MG/ML MITOMYCIN C 0.5 MG/ML MITOXANTRONE 2.0 MG/ML PACLITAXEL (TAXOL) 6.0 MG/ML THIOTEPA 10.0 MG/ML VINCRISTINE SULFATE 1.0 MG/ML | no breakthrough up to 240 minutes no breakthrough up to 240 minutes no breakthrough up to 240 minutes no breakthrough up to 240 minutes no breakthrough up to 240 minutes no breakthrough up to 240 minutes no breakthrough up to 240 minutes breakthrough after 90.5 minutes no breakthrough up to 240 minutes | | |----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------| | Materials | Nitrile | | Nitrile | | Identical | | | Color | Green | | | Blue or White | | Similar (green versus blue) | | Standards used | ASTM D6319-10 ASTM D5151-06 ASTM D6124-06 ASTM D6978-05(2013) ASTM D412-16 ASTM D3767-03 ANSI/AAMI/ISO 10993-5 ISO 10993-10 ISO 2859-1 | | | ASTM D6319-10 ASTM D5151-11 ASTM D6124-11 ASTM D6978-05 (Reapproved 2013) ISO 10993-10 | Identical Note: ASTM D412-16, D3767-03 and ISO 2859-1 are supporting standards | | | Non-Sterile, Single Use, disposable | Yes | | Yes | | Identical | | | Packaging | Packed in Dispenser Boxes | | | Packed in Dispenser Boxes | Identical | | | Labeling Features | Non-Sterile Powder Free Examination Gloves Ambidextrous, by Size Single use only Device Color Manufactured by: Lot Number: Quantity by Weight Made in Malaysia | | | Non-Sterile Powder Free Examination Gloves Ambidextrous, by Size Single use only Device Color Manufactured by: Lot Number: Quantity by Weight Made in Malaysia | | Identical | | Sizes | X-Small, Small, Medium, Large, X-Large | | | X-Small, Small, Medium, Large, X-Large | | Identical | | Labeling Claim | 1. Low Dermatitis Potential 2. Tested for Use with Chemotherapy Drugs | | | 1. Low Dermatitis Potential 2. Tested for Use with Chemotherapy Drugs | | Identical | | Biocompatibility | Cytotoxicity compliant as per ANSI/AAMI/ISO 10993-5 Sensitization and irritation compliant as per ISO 10993-10 | | | Sensitization and irritation compliant as per ISO 10993-10 | | Identical for sensitization and irritation. Our subject device also tested for Cytotoxicity | | Modified Draize Test | Under the conditions of the study, there was no clinical evidence of the presence of residual | | | Under the conditions of the study, there was no clinical evidence of the presence of residual | | Identical | {7}------------------------------------------------ | chemical additives that may induce Type IV allergy in the un-sensitized general user populations in the tested articles | chemical additives that may induce Type IV allergy in the un-sensitized general user populations in the tested articles | |-------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------| |-------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------| - 8. Summary of Non-Clinical Performance Test The subject device was tested successfully against: - a) Measurement of Dimensions according to Standard Practice for Rubber—Measurement of Dimensions ASTM D3767-03 (2014): Testing was conducted on lot numbers of each size. All acceptance criteria according Standard Specification for Nitrile Examination Gloves for Medical Application ASTM D6319-10 (2015) were met. The number of defective samples was 0; less or equal than the maximum allowable. - b) Measurement of Tensile test according to Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension ASTM D412-16: Testing was conducted on lot numbers of each size. All acceptance criteria according Standard Specification for Nitrile Examination Gloves for Medical Application ASTM D6319-10 (2015) were met. The number of defective samples was 0; less or equal than the maximum allowable. - Measurement of Residual powder according to Standard Test Method for Residual Powder on Medical c) Gloves ASTM D6124-06 (2017): Testing was conducted on lot numbers of each size. All acceptance criteria according Standard Specification for Nitrile Examination Gloves for Medical Application ASTM D6319-10 (2015) were met. The number of defective samples were 0; less or equal than the maximum allowable. d) Measurement of Water leak test according to Standard Test Method for Detection of Holes in Medical Gloves ASTM D5151-06 (2015): Testing was conducted on lot numbers of each size. All acceptance criteria according Standard Specification for Nitrile Examination Gloves for Medical Application ASTM D6319-10 (2015) were met. In three of the five lots, the number of defective samples was 1; less or equal than the maximum allowable (which is 2 per lot). In two of the three lots, the number of defective samples was zero; less or equal than the maximum allowable. - e) Low dermatitis potential according to Standard Test Method For Human Repeat Insult Patch Testing Of Medical Gloves ASTM D6355-07: Under the conditions of the study, there was no clinical evidence of residual chemical additives that may induce Type IV allergy in the un-sensitized general user populations in the tested articles. - f) Permeation by Chemotherapy Drugs according to Standard Practice For Assessment Of Resistance Of Medical Gloves To Permeation By Chemotherapy Drugs ASTM D6978-05 (Reapproved 2013) Under the conditions of the study, 15 chemotherapy drugs passed the test, while Carmustine (BCNU) (3.3 mg/ml) failed at 15.9 breakthrough detection time (in minutes), and Thiotepa (10.0 mg/ml) failed at 11.1. - Biocompatibility testing was successfully tested in accordance with ANSI AAMI ISO 10993-5:2009/(R)2014 g) (Cytotoxicity) and ISO 10993-10 Third Edition 2010-08-01 (irritation/sensitization) {8}------------------------------------------------ # 9. Summary of Clinical Test Not applicable. ## 10. Conclusion The conclusions drawn from the nonclinical (discussed above) demonstrate that the device is as safe, as effective, and performs as well as or better than the predicate device

Powder-free Nitrile Patient Examination Glove, Green Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs

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Powder-free Nitrile Patient Examination Glove, Green Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

Panel 1

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Product Code Matches

Special Control Matches

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