(27 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs, as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
The SafeSource Direct Blue Powder-Free Nitrile Exam Gloves are a patient examination glove that is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs. The purpose of this submission is to add two additional sizes (AMERI-TUFF Series 4000 XS and XXL) and additional series (AMERI-TOUCH Series 5000 XS through XXL) of SafeSource Direct Blue Powder-Free Nitrile Exam Glove
This document is a 510(k) Summary for a medical device (SafeSource Direct Blue Powder-Free Nitrile Exam Gloves) seeking FDA clearance. The document focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical performance data (i.e., laboratory testing). It does not involve a study of an AI-powered device or a human-in-the-loop performance study.
Therefore, many of the requested elements related to AI/MRMC studies, expert ground truth adjudication, and training/test set details for AI models are not applicable to this document. I will focus on the acceptance criteria and the study that proves the device meets those criteria, as detailed in the provided text.
Here's a breakdown based on the information provided in the document:
1. Table of Acceptance Criteria and Reported Device Performance
The device under review includes two series of gloves: AMERI-TUFF Series 4000 and AMERI-TOUCH Series 5000. Not all tests explicitly differentiate between the series in the summary table, but chemotherapy permeation times are distinct.
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test | Length (mm):XS/S: ≥ 220M/L/XL/XXL: ≥ 230Width (mm):XS: 70 ± 10S: 80 ± 10M: 95 ± 10L: 110 ± 10XL: 120 ± 10XXL: 130 ± 10Thickness (mm):Finger: ≥ 0.05Palm: ≥ 0.05 | Length (mm):XS/S: ≥ 220 / PassM/L/XL/XXL: ≥ 230 / PassWidth (mm):XS: 70 ± 10 / PassS: 80 ± 10 / PassM: 95 ± 10 / PassL: 110 ± 10 / PassXL: 120 ± 10 / PassXXL: 130 ± 10 / PassThickness (mm):Finger: 0.05 / PassPalm: 0.05 / Pass |
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 | Complies with ASTM D6319-19 and ASTM D5151-06 (Though the table specifically lists "Complies with ASTM D6319-19 and ASTM D5151-06", the stated acceptance criteria for D5151 is AQL 2.5, implying the result also meets this). |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 < 2.0 mg | 0.08-0.44 mg / Pass |
| ASTM D412 | Physical Properties (Tensile Strength & Elongation) | Before Aging:Tensile Strength ≥ 14 MPaUltimate Elongation ≥ 500%After Aging:Tensile Strength ≥ 14 MPaUltimate Elongation ≥ 400%Meet the requirements of ASTM D412 AQL 4.0 (for both before and after aging) | Before Aging:Tensile Strength: 14 – 19 MPaUltimate Elongation: 515 - 540% / PassAfter Aging:Tensile Strength: (Implied to be ≥ 14 MPa, results not explicitly stated but "Pass")Ultimate Elongation: (Implied to be ≥ 400%, results not explicitly stated but "Pass")Pass (for AQL 4.0) |
| ISO 10993-11 | Acute Systemic Toxicity | Non-Acute Systemic Toxicity | Under conditions of the study, did not show acute systemic toxicity in vivo. / Pass |
| ISO 10993-10 | Irritation | Non-irritating | Under conditions of the study, not an irritant. / Pass |
| ISO 10993-10 | Sensitization | Non-sensitizing | Under conditions of the study, not a sensitizer. / Pass |
| ASTM D6978-05 (Reapproved 2019) | Permeation by Chemotherapy Drugs | Specified minimum breakthrough detection times for various chemotherapy drugs (values vary by drug). Note: Carmustine and Thio-Tepa have "low permeation times" and are "Not recommended for use with these drugs." (Acceptance is implicitly meeting the tested values or demonstrating non-inferiority to predicate for those above threshold.) | AMERI-TUFF Series 4000:Carmustine (BCNU) 3.3 mg/ml: 35.8 MinutesCisplatin 1.0 mg/ml: ≥ 240 MinutesCyclophosphamide (Cytoxan) 20.0 mg/ml: ≥ 240 MinutesDacarbazine (DTIC) 10.0 mg/ml: ≥ 240 MinutesDoxorubicin Hydrochloride 2.0 mg/ml: ≥ 240 MinutesEtoposide (Toposar) 20.0 mg/ml: ≥ 240 MinutesFluorouracil 50.0 mg/ml: ≥ 240 MinutesMethotrexate 25 mg/ml: ≥ 240 MinutesMitomycin C 0.5 mg/ml: ≥ 240 MinutesPaclitaxel (Taxol) 6.0 mg/ml: ≥ 240 MinutesThio-Tepa 10.0 mg/ml: 87.0 MinutesVincristine Sulfate (Oncovin) 1.0 mg/ml: ≥ 240 MinutesAMERI-TOUCH Series 5000:Carmustine (BCNU) 3.3 mg/ml: 22.5 MinutesCisplatin 1.0 mg/ml: ≥ 240 MinutesCyclophosphamide (Cytoxan) 20.0 mg/ml: ≥ 240 MinutesDacarbazine (DTIC) 10.0 mg/ml: ≥ 240 MinutesDoxorubicin Hydrochloride 2.0 mg/ml: ≥ 240 MinutesEtoposide (Toposar) 20.0 mg/ml: ≥ 240 MinutesFluorouracil 50.0 mg/ml: ≥ 240 MinutesMethotrexate 25 mg/ml: ≥ 240 MinutesMitomycin C 0.5 mg/ml: ≥ 240 MinutesPaclitaxel (Taxol) 6.0 mg/ml: ≥ 240 MinutesThio-Tepa 10.0 mg/ml: 37.5 MinutesVincristine Sulfate (Oncovin) 1.0 mg/ml: ≥ 240 Minutes |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for each specific test (e.g., number of gloves tested for physical dimensions, watertightness, or chemotherapy permeation). However, it indicates compliance with recognized standards such as ASTM D6319, ASTM D5151, ASTM D6124, ASTM D412, and ASTM D6978-05, and ISO 10993 series. These standards typically specify the required sample sizes for testing.
The data provenance is not explicitly stated in terms of country of origin or whether it's retrospective/prospective. Given this is a 510(k) submission for a medical device (gloves), the testing would be prospective laboratory testing conducted to demonstrate compliance with performance standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable. The "ground truth" for glove performance tests outlined here is based on objective laboratory measurements against established ASTM and ISO standards, not on expert interpretations or consensus of medical images or clinical outcomes.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods are typically employed in studies involving human interpretation (e.g., radiologists reading medical images) to resolve discrepancies. The tests described are objective, physical, and chemical property measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered devices where human readers are involved in diagnosis or intervention. This submission pertains to physical and chemical properties of examination gloves.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
No, this is not an AI algorithm. The performance evaluation is based on standard laboratory testing of the physical and chemical properties of the gloves.
7. The Type of Ground Truth Used
The "ground truth" for the performance claims of these gloves is based on:
- Compliance with established industry standards: ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards provide specific methodologies and acceptance criteria for physical properties (dimensions, tensile strength, elongation), watertightness, powder content, and biocompatibility.
- Laboratory measurements: Objective measurements of the gloves' properties (e.g., length, width, thickness, force required to break, elongation percentage, breakthrough time for chemotherapy drugs) against predefined thresholds within the standards.
8. The Sample Size for the Training Set
This information is not applicable. This is not an AI model requiring a training set. The device is a physical product (gloves) whose performance is established through manufacturing processes and validated through standardized testing.
9. How the Ground Truth for the Training Set was Established
This is not applicable as there is no AI training set.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services - USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The FDA logo is a recognizable symbol associated with the regulation and oversight of food and drug products in the United States.
March 19, 2025
SafeSource Direct LLC % Grace Powers Founder/ Principal Consultant Powers Regulatory Consulting 2451 Cumberland Parkway SE Suite 3740 Atlanta, Georgia 30339
Re: K250502
Trade/Device Name: SafeSource Direct Blue Powder-Free Nitrile Exam Gloves (AMERI-TUFF Series 4000, AMERI-TOUCH Series 5000) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, OPJ Dated: February 18, 2025 Received: February 20, 2025
Dear Grace Powers:
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 (the 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 available 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}------------------------------------------------
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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-regulatory
{2}------------------------------------------------
assistance/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,
ALLAN GUAN -S
For Bifeng Qian, M.D., Ph.D. Assistant Director DHT4C: Division of Infection Control Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Indications for Use
510(k) Number (if known) K250502
Device Name
SafeSource Direct Blue Powder-Free Nitrile Exam Gloves (AMERI-TUFF Series 4000)
Indications for Use (Describe)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs, as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Carmustine (BCNU) 3.3 mg/ml 35.8 Minutes Cisplatin 1.0 mg/ml ≥ 240 Minutes Cyclophosphamide (Cytoxan) 20.0 mg/ml ≥ 240 Minutes Dacarbazine (DTIC) 10.0 mg/ml ≥ 240 Minutes Doxorubicin Hydrochloride 2.0 mg/ml ≥ 240 Minutes Etoposide (Toposar) 20.0 mg/ml > 240 Minutes Fluorouracil 50.0 mg/ml 0.5 mg/ml ≥ 240 Minutes Methotrexate 25 mg/ml ≥ 240 Minutes Mitomycin C 0.5 mg/ml ≥ 240 Minutes Paclitaxel (Taxol) 6.0 mg/ml ≥ 240 Minutes Thio-Tepa 10.0 mg/ml 87.0 Minutes Vincristine Sulfate (Oncovin) 1.0 mg/ml > 240 Minutes
Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 35.8 Minutes Thio-Tepa 10.0 mg/ml 87.0 Minutes Warning: Not recommended for use with these drugs.
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."
{4}------------------------------------------------
Indications for Use
510(k) Number (if known) K250502
Device Name
SafeSource Direct Blue Powder-Free Nitrile Exam Gloves (AMERI-TOUCH Series 5000)
Indications for Use (Describe)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs, as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Carmustine (BCNU) 3.3 mg/ml 22.5 Minutes Cisplatin 1.0 mg/ml ≥ 240 Minutes Cyclophosphamide (Cytoxan) 20.0 mg/ml ≥ 240 Minutes Dacarbazine (DTIC) 10.0 mg/ml ≥ 240 Minutes Doxorubicin Hydrochloride 2.0 mg/ml ≥ 240 Minutes Etoposide (Toposar) 20.0 mg/ml > 240 Minutes Fluorouracil 50.0 mg/ml 0.5 mg/ml ≥ 240 Minutes Methotrexate 25 mg/ml ≥ 240 Minutes Mitomycin C 0.5 mg/ml ≥ 240 Minutes Paclitaxel (Taxol) 6.0 mg/ml ≥ 240 Minutes Thio-Tepa 10.0 mg/ml 37.5 Minutes Vincristine Sulfate (Oncovin) 1.0 mg/ml > 240 Minutes
Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 22.5 Minutes Thio-Tepa 10.0 mg/ml 37.5 Minutes Warning: Not recommended for use with these drugs.
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."
{5}------------------------------------------------
510(k) Summary
Image /page/5/Picture/2 description: The image contains the logo for SafeSource Direct. The logo consists of a red shield with a blue, stylized "S" in the center. To the right of the shield is the text "SafeSource" in a bold, sans-serif font, with the word "Direct" underneath in a smaller font. Below "Direct" is the text "Personal Protective Equipment" in an even smaller font.
510(k) Summary K250502
In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the SafeSource Direct Blue Powder-Free Nitrile Exam Gloves Special 510(k) premarket notification.
| Sponsor: | SafeSource Direct, LLC200 St Nazaire Rd.Broussard, LA 70518Sponsor Contact: Justin Hollingsworth |
|---|---|
| Submission Contact: | Grace Powers, MS, MBA, RACFounder/Principal ConsultantPowers Regulatory ConsultingTel: 404-931-8730 |
| Date Prepared: | March 19, 2025 |
Subject Device:
Trade Name: SafeSource Direct Blue Powder-Free Nitrile Exam Gloves (AMERI-TUFF Series 4000, AMERI-TOUCH Series 5000) Common/Usual Name: Non-Powdered Patient Examination Glove Classification Name: Polymer Patient Examination Glove, Patient Examination Glove, Specialty Classification Regulation: 21 CFR 880.6250 Product Code: LZA, LZC, OPJ Device Class: Class I, Reserved Classification Panel: General Hospital and Personal Use Devices
Predicate Device: Legally marketed device to which substantial equivalence is claimed: Trade/Proprietary Name: SafeSource Direct Blue Powder-Free Nitrile Exam Gloves Manufacturer: SafeSource Direct, LLC 510(k): K222898 Common/Usual Name: Non-Powdered Patient Examination Glove Classification Name: Polymer Patient Examination Glove, Patient Examination Glove, Specialty Classification Regulation: 21 CFR 880.6250 Product Code: LZA, LZC Device Class: Class I, Reserved Classification Panel: General Hospital and Personal Use Devices
Device Description
The SafeSource Direct Blue Powder-Free Nitrile Exam Gloves are a patient examination glove that is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy
{6}------------------------------------------------
510(k) Summary
drugs. The purpose of this submission is to add two additional sizes (AMERI-TUFF Series 4000 XS and XXL) and additional series (AMERI-TOUCH Series 5000 XS through XXL) of SafeSource Direct Blue Powder-Free Nitrile Exam Glove
Indications for Use- AMERI-TUFF Series 4000 Gloves
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs, as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Carmustine (BCNU) 3.3 mg/ml 35.8 Minutes Cisplatin 1.0 mg/ml ≥ 240 Minutes Cyclophosphamide (Cytoxan) 20.0 mg/ml ≥ 240 Minutes Dacarbazine (DTIC) 10.0 mg/ml ≥ 240 Minutes Doxorubicin Hydrochloride 2.0 mg/ml ≥ 240 Minutes Etoposide (Toposar) 20.0 mg/ml ≥ 240 Minutes Fluorouracil 50.0 mg/ml 0.5 mg/ml ≥ 240 Minutes Methotrexate 25 mg/ml ≥ 240 Minutes Mitomycin C 0.5 mg/ml ≥ 240 Minutes Paclitaxel (Taxol) 6.0 mg/ml ≥ 240 Minutes Thio-Tepa 10.0 mg/ml 87.0 Minutes Vincristine Sulfate (Oncovin) 1.0 mg/ml ≥ 240 Minutes
Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 35.8 Minutes Thio-Tepa 10.0 mg/ml 87.0 Minutes Warning: Not recommended for use with these drugs.
{7}------------------------------------------------
Indications for Use- AMERI-TOUCH Series 5000
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs, as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Carmustine (BCNU) 3.3 mg/ml 22.5 Minutes Cisplatin 1.0 mg/ml ≥ 240 Minutes Cyclophosphamide (Cytoxan) 20.0 mg/ml ≥ 240 Minutes Dacarbazine (DTIC) 10.0 mg/ml ≥ 240 Minutes Doxorubicin Hydrochloride 2.0 mg/ml ≥ 240 Minutes Etoposide (Toposar) 20.0 mg/ml ≥ 240 Minutes Fluorouracil 50.0 mg/ml 0.5 mg/ml ≥ 240 Minutes Methotrexate 25 mg/ml ≥ 240 Minutes Mitomycin C 0.5 mg/ml ≥ 240 Minutes Paclitaxel (Taxol) 6.0 mg/ml ≥ 240 Minutes Thio-Tepa 10.0 mg/ml 37.5 Minutes Vincristine Sulfate (Oncovin) 1.0 mg/ml ≥ 240 Minutes
Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 22.5 Minutes Thio-Tepa 10.0 mg/ml 37.5 Minutes Warning: Not recommended for use with these drugs.
Technological Characteristics
The SafeSource Direct Blue Powder-Free Nitrile Exam Gloves has similar technological characteristics as the predicate device.
| Device | Subject Device:SafeSource Direct Blue | Predicate Device:SafeSource Direct Blue | |
|---|---|---|---|
| Comparison | Powder-Free Nitrile ExamGloves | Powder-Free Nitrile ExamGloves K222898 | Comparison |
| Name | SafeSource Direct BluePowder-Free Nitrile ExamGloves | SafeSource Direct BluePowder-Free Nitrile ExamGloves | Identical |
| Manufacturer | SafeSource Direct, LLC | SafeSource Direct, LLC | Identical |
| FDA Product Code | LZA, LZC, OPJ | LZA, LZC | Identical |
| Regulation Name | Polymer PatientExamination Glove, PatientExamination Glove, Specialty | Polymer PatientExamination Glove, PatientExamination Glove, Specialty | Identical |
| RegulationNumber | 21 CFR 880.6250 | 21 CFR 880.6250 | Identical |
| Intended Use/Indications for Use | A patient examination gloveis a disposable deviceintended for medical | A patient examination gloveis a disposable deviceintended for medical | The device namehas beenupdated to |
| Device Comparison | Subject Device:SafeSource Direct BluePowder-Free Nitrile ExamGloves | Predicate Device:SafeSource Direct BluePowder-Free Nitrile ExamGloves K222898 | Comparison |
| purposes that is worn on theexaminer's hands to preventcontamination betweenpatient and examiner.These gloves were tested foruse with chemotherapydrugs, as per ASTM D6978-05(Reapproved 2019) StandardPractice for Assessment ofMedical Gloves toPermeation byChemotherapy Drugs. | purposes that is worn on theexaminer's hands to preventcontamination betweenpatient and examiner. Thesegloves were tested for usewith chemotherapy drugs,as per ASTM D6978-05 | differentiate thetwo lines ofgloves. | |
| Carmustine (BCNU) 3.3mg/ml 35.8 Minutes (Series4000) or 22.5 Minutes(Series 5000) | Carmustine (BCNU) 3.3mg/ml 35.8 Minutes | Thebreakthroughtime informationis identical withthe exception ofthe Carmustineand Thio-Tepabreakthroughtimes for theSeries 5000gloves. | |
| Cisplatin 1.0 mg/ml ≥ 240Minutes | Cisplatin 1.0 mg/ml ≥ 240Minutes | ||
| Cyclophosphamide(Cytoxan) 20.0 mg/ml ≥ 240Minutes | Cyclophosphamide(Cytoxan) 20.0 mg/ml ≥ 240Minutes | ||
| Dacarbazine (DTIC) 10.0mg/ml ≥ 240 Minutes | Dacarbazine (DTIC) 10.0mg/ml ≥ 240 Minutes | ||
| Doxorubicin Hydrochloride2.0 mg/ml ≥ 240 Minutes | Doxorubicin Hydrochloride2.0 mg/ml ≥ 240 Minutes | ||
| Etoposide (Toposar) 20.0mg/ml ≥ 240 Minutes | Etoposide (Toposar) 20.0mg/ml ≥ 240 Minutes | ||
| Fluorouracil 50.0 mg/ml 0.5mg/ml ≥ 240 Minutes | Fluorouracil 50.0 mg/ml 0.5mg/ml ≥ 240 Minutes | ||
| Methotrexate 25 mg/ml ≥240 Minutes | Methotrexate 25 mg/ml ≥240 Minutes | ||
| Mitomycin C 0.5 mg/ml ≥240 Minutes | Mitomycin C 0.5 mg/ml ≥240 Minutes | ||
| Paclitaxel (Taxol) 6.0 mg/ml≥ 240 Minutes | Paclitaxel (Taxol) 6.0 mg/ml≥ 240 Minutes | ||
| Thio-Tepa 10.0 mg/ml 43.7Minutes (Series 4000) or37.5 Minutes (Series 5000) | Thio-Tepa 10.0 mg/ml 87.0Minutes | ||
| Vincristine Sulfate (Oncovin)1.0 mg/ml ≥ 240 Minutes | |||
| Please note that thefollowing drugs have lowpermeation times:Carmustine (BCNU) 3.3mg/ml 25.8 Minutes | |||
| Subject Device: | Predicate Device: | ||
| DeviceComparison | SafeSource Direct BluePowder-Free Nitrile ExamGloves | SafeSource Direct BluePowder-Free Nitrile ExamGloves K222898 | Comparison |
| Vincristine Sulfate (Oncovin)$1.0 mg/ml \ge 240 \text{ Minutes}$ | Thio-Tepa 10.0 mg/ml 43.7Minutes | ||
| Please note that thefollowing drugs have lowpermeation times:Carmustine (BCNU)3.3mg/ml 35.5 Minutes or25.5 Minutes (Series 5000)Thio-Tepa 10.0 mg/ml 43.7Minutes (Series 4000) or22.5 Minutes (Series 5000)Warning: Not recommendedfor use with these drugs. | Not recommended for usewith these drugs. | ||
| Sizes | Series 4000: Extra Small,Extra Extra LargeSeries 5000: Extra Small,Small, Medium, Large, ExtraLarge, Extra Extra Large | Series 4000:Small, Medium, Large, ExtraLarge | Similar- thesubject device isadding twoadditional sizesand another lineof gloves. |
| Materials | Nitrile | Nitrile | Similar |
| Color | Blue | Blue | Identical |
| Condition of Use | Single Use (Disposable) | Single Use (Disposable) | Identical |
| Powder orPowder-Free | Powder free | Powder Free | Identical |
| Dimensions-Length | Complies with ASTM D6319-19 (both series)XS: 220mm minS: 220mm minM: 230mm minL: 230mm minXL: 230mm minXXL: 230mm min | Complies with ASTM D6319-19S: 220mm minM: 230mm minL: 230mm minXL: 230mm min | Similar- bothfollow thestandard |
| Dimensions-Width | Complies with ASTM D6319-19 (both series)XS: 70±10mmS: 80±10mmM: 95±10mmL: 110±10mmXL: 120±10mmXXL: 130±10mm | Complies with ASTM D6319-19S: 85±10mmM: 95±10mmL: 105±10mmXL: 115±10mm | Similar- Bothcomply with thestandard. |
| Dimensions-Thickness | Complies with ASTM D6319-19 | Complies with ASTM D6319-19 | Identical |
| Device Comparison | Subject Device:SafeSource Direct BluePowder-Free Nitrile ExamGloves | Predicate Device:SafeSource Direct BluePowder-Free Nitrile ExamGloves K222898 | Comparison |
| Palm - 0.05 minimumFinger - 0.05 minimum | Palm - 0.05 minimumFinger - 0.05 minimum | ||
| Physical Properties- Tensile Strength | Complies with ASTM D6319-19Tensile Strength:Before Aging ≥14 MPa, minAfter Aging ≥14 MPa, min | Complies with ASTM D6319-19Tensile Strength:Before Aging ≥14 MPa, minAfter Aging ≥14 MPa, min | Identical |
| Physical Properties- Elongation | Elongation:Before Aging 500% MinAfter Aging 400% Min | Elongation:Before Aging 500% MinAfter Aging 400% Min | Identical |
| Freedom fromHoles | Complies with ASTM D6319-19and ASTM D5151-06 | Complies with ASTM D6319-19and ASTM D5151-06 G-1,AQL2.5 | Identical |
| Residual Powder | Max. 0.42mg per glove | Max. 0.42mg per glove | Identical |
| Biocompatibility | ISO 10993-10: Not askin irritant, not askin sensitizerISO 10993-5:CytotoxicISO 10993-11: No acutesystemic toxicity | ISO 10993-10: Not askin irritant, not askin sensitizerISO 10993-5:CytotoxicISO 10993-11: No acutesystemic toxicity | Identical |
| Sterility | Non-sterile | Non-sterile | Identical |
| Series 5000:ChemotherapyDrugs Tested withMinimumBreakthroughDetection Time asTested per ASTMD 6978 | Carmustine (BCNU) 3.3mg/ml: 22.5 Minutes | Carmustine (BCNU) 3.3mg/ml: 35.8 Minutes | Different- Thebreakthroughtime was shorterfor the Series5000 subjectdevice. |
| Cisplatin 1.0 mg/ml: ≥240Minutes | Cisplatin 1.0 mg/ml: ≥240Minutes | Identical | |
| Cyclophosphamide(Cytoxan) 20.0 mg/ml: ≥240Minutes | Cyclophosphamide(Cytoxan) 20.0 mg/ml: ≥240Minutes | Identical | |
| Dacarbazine (DTIC) 10.0mg/ml: ≥240 Minutes | Dacarbazine (DTIC) 10.0mg/ml: ≥240 Minutes | Identical | |
| Doxorubicin Hydrochloride2.0 mg/ml: ≥240 Minutes | Doxorubicin Hydrochloride2.0 mg/ml: ≥240 Minutes | Identical | |
| Etoposide (Toposar) 20.0mg/ml: ≥240 Minutes | Etoposide (Toposar) 20.0mg/ml: ≥240 Minutes | Identical | |
| Fluorouracil 50.0 mg/ml:≥240 Minutes | Fluorouracil 50.0 mg/ml:≥240 Minutes | Identical | |
| Methotrexate 25 mg/ml:≥240 Minutes | Methotrexate 25 mg/ml:≥240 Minutes | Identical | |
| Mitomycin C 0.5 mg/ml: ≥240 Minutes | Mitomycin C 0.5 mg/ml: ≥240 Minutes | Identical | |
| Paclitaxel (Taxol) 6.0 mg/ml:≥240 Minutes | Paclitaxel (Taxol) 6.0 mg/ml:≥240 Minutes | Identical | |
| Thio-Tepa 10.0 mg/ml: 37.5Minutes | Thio-Tepa 10.0 mg/ml: 87.0Minutes | Different- Thebreakthroughtime was shorterfor the Series5000 subjectdevice. | |
| Vincristine Sulfate (Oncovin)1.0 mg/ml: ≥240 Minutes | Vincristine Sulfate (Oncovin)1.0 mg/ml: ≥240 Minutes | Identical |
{8}------------------------------------------------
{9}------------------------------------------------
{10}------------------------------------------------
510(k) Summary
{11}------------------------------------------------
Special 510(k) – SafeSource Direct, LLC
510(k) Summary
SafeSource Direct Blue Powder-Free Nitrile Exam Gloves
Non-Clinical Performance Data
| Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM D6319 | Physical DimensionsTest | Length (mm):XS/S: ≥ 220M/L/XL/XXL: ≥ 230Width (mm):XS: 70 ± 10S: 80 ± 10M: 95 ± 10L: 110 ± 10XL: 120 ± 10XXL: 130 ± 10Thickness (mm):Finger: ≥ 0.05Palm: ≥ 0.05 | Length (mm):XS/S: ≥ 220 / PassM/L/XL/XXL: ≥ 230 / PassWidth (mm):XS: 70 ± 10 / PassS: 80 ± 10 / PassM: 95 ± 10 / PassL: 110 ± 10 / PassXL: 120 ± 10 / PassXXL: 130 ± 10 / PassThickness (mm):Finger: 0.05 / PassPalm: 0.05 / Pass |
| ASTM D5151 | Watertightness Test forDetection of Holes | Meet the requirements of ASTMD5151 AQL 2.5 | Complies with ASTM D6319-19 and ASTM D5151-06 |
| ASTM D6124 | Powder Content | Meet the requirements of ASTMD6124 < 2.0 mgMeet the requirements of ASTMD412 AQL 4.0 | 0.08-0.44 mg / PassPass |
| ASTM D412 | Physical Properties | Before AgingTensile Strength ≥ 14 MPaUltimate Elongation ≥ 500% | 14 – 19 MPa515 - 540% |
{12}------------------------------------------------
Special 510(k) - SafeSource Direct, LLC
510(k) Summary
SafeSource Direct Blue Powder-Free Nitrile Exam Gloves
| Meet the requirements of ASTM D412 AQL 4.0 | Pass | |||||||
|---|---|---|---|---|---|---|---|---|
| AfterAging | Tensile Strength $\geq$ 14 MPa Ultimate Elongation $\geq$ 400% | Pass | ||||||
| ISO 10993-11 | Acute SystemicToxicity | Non-Acute Systemic Toxicity | Under conditions of thestudy, did not show acutesystemic toxicity in vivo. /Pass | |||||
| ISO 10993-10 | Irritation | Non-irritating | Under conditions of thestudy, not an irritant. / Pass | |||||
| ISO 10993-10 | Sensitization | Non-sensitizing | Under conditions of thestudy, not a sensitizer. /Pass |
Permeation testing was conducted to support the addition of the labeling claim: Tested for use with chemotherapy drugs. The proposed device was tested according to ASTM D6978-05 (Reapproved 2019), Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs (FR Recognition Number 6-147).
Conclusion
The conclusions drawn from the non-clinical tests demonstrate that the subject device, SafeSource Direct Blue Powder-Free Nitrile Gloves (AMERI-TUFF Series 4000, AMERI-TOUCH Series 5000) is as safe, as effective, and performs as well as or better than the legally marketed predicate device, K222898.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.