SafeSource Direct Blue Powder-Free Nitrile Exam Gloves (AMERI-TUFF Series 4000, AMERI-TOUCH Series 5000)

K250502 · Safesource Direct, LLC · LZA · Mar 19, 2025 · General Hospital

Device Facts

• Record ID: K250502
• Device Name: SafeSource Direct Blue Powder-Free Nitrile Exam Gloves (AMERI-TUFF Series 4000, AMERI-TOUCH Series 5000)
• Applicant: Safesource Direct, LLC
• Product Code: LZA · General Hospital
• Decision Date: Mar 19, 2025
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

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.

Device Story

Disposable nitrile patient examination gloves; worn on examiner's hands to prevent cross-contamination between patient and examiner. Device serves as physical barrier. Tested for permeation resistance against specific chemotherapy drugs per ASTM D6978-05. Used in clinical settings; operated by healthcare professionals. Output is physical protection; informs clinical decision-making regarding barrier safety during chemotherapy handling. Benefits patient and examiner by reducing exposure to contaminants and hazardous drugs.

Clinical Evidence

Bench testing only. Performance evaluated against ASTM D6319 (dimensions, physical properties), ASTM D5151 (watertightness), ASTM D6124 (powder content), and ASTM D412 (tensile strength/elongation). Biocompatibility testing performed per ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation/sensitization), and ISO 10993-11 (acute systemic toxicity). Chemotherapy permeation resistance tested per ASTM D6978-05.

Technological Characteristics

Material: Nitrile. Form factor: Powder-free, blue, disposable, non-sterile. Dimensions and physical properties comply with ASTM D6319-19. Chemotherapy resistance tested per ASTM D6978-05. Biocompatibility per ISO 10993 series.

Indications for Use

Indicated for use as a disposable patient examination glove worn on the examiner's hands to prevent contamination between patient and examiner. Tested for use with specific chemotherapy drugs.

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

• SafeSource Direct Blue Powder-Free Nitrile Exam Gloves (K222898)

Submission Summary (Full Text)

{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 ([e-mail]) or phone [phone] 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, LLC<br>200 St Nazaire Rd.<br>Broussard, LA 70518<br>Sponsor Contact: Justin Hollingsworth |
|---------------------|-----------------------------------------------------------------------------------------------------------------|
| Submission Contact: | Grace Powers, MS, MBA, RAC<br>Founder/Principal Consultant<br>Powers Regulatory Consulting<br>Tel: [phone] |
| 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:<br>SafeSource Direct Blue | Predicate Device:<br>SafeSource Direct Blue | |
|--------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison | Powder-Free Nitrile Exam<br>Gloves | Powder-Free Nitrile Exam<br>Gloves K222898 | Comparison |
| Name | SafeSource Direct Blue<br>Powder-Free Nitrile Exam<br>Gloves | SafeSource Direct Blue<br>Powder-Free Nitrile Exam<br>Gloves | Identical |
| Manufacturer | SafeSource Direct, LLC | SafeSource Direct, LLC | Identical |
| FDA Product Code | LZA, LZC, OPJ | LZA, LZC | Identical |
| Regulation Name | Polymer Patient<br>Examination Glove, Patient<br>Examination Glove, Specialty | Polymer Patient<br>Examination Glove, Patient<br>Examination Glove, Specialty | Identical |
| Regulation<br>Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Identical |
| Intended Use/<br>Indications for Use | A patient examination glove<br>is a disposable device<br>intended for medical | A patient examination glove<br>is a disposable device<br>intended for medical | The device name<br>has been<br>updated to |
| Device Comparison | Subject Device:<br>SafeSource Direct Blue<br>Powder-Free Nitrile Exam<br>Gloves | Predicate Device:<br>SafeSource Direct Blue<br>Powder-Free Nitrile Exam<br>Gloves K222898 | Comparison |
| | purposes that is worn on the<br>examiner's hands to prevent<br>contamination between<br>patient and examiner.<br>These gloves were tested for<br>use with chemotherapy<br>drugs, as per ASTM D6978-<br>05<br>(Reapproved 2019) Standard<br>Practice for Assessment of<br>Medical Gloves to<br>Permeation by<br>Chemotherapy Drugs. | purposes that is worn on the<br>examiner's hands to prevent<br>contamination between<br>patient and examiner. These<br>gloves were tested for use<br>with chemotherapy drugs,<br>as per ASTM D6978-05<br> | differentiate the<br>two lines of<br>gloves. |
| | Carmustine (BCNU) 3.3<br>mg/ml 35.8 Minutes (Series<br>4000) or 22.5 Minutes<br>(Series 5000) | Carmustine (BCNU) 3.3<br>mg/ml 35.8 Minutes | The<br>breakthrough<br>time information<br>is identical with<br>the exception of<br>the Carmustine<br>and Thio-Tepa<br>breakthrough<br>times for the<br>Series 5000<br>gloves. |
| | Cisplatin 1.0 mg/ml ≥ 240<br>Minutes | Cisplatin 1.0 mg/ml ≥ 240<br>Minutes | |
| | Cyclophosphamide<br>(Cytoxan) 20.0 mg/ml ≥ 240<br>Minutes | Cyclophosphamide<br>(Cytoxan) 20.0 mg/ml ≥ 240<br>Minutes | |
| | Dacarbazine (DTIC) 10.0<br>mg/ml ≥ 240 Minutes | Dacarbazine (DTIC) 10.0<br>mg/ml ≥ 240 Minutes | |
| | Doxorubicin Hydrochloride<br>2.0 mg/ml ≥ 240 Minutes | Doxorubicin Hydrochloride<br>2.0 mg/ml ≥ 240 Minutes | |
| | Etoposide (Toposar) 20.0<br>mg/ml ≥ 240 Minutes | Etoposide (Toposar) 20.0<br>mg/ml ≥ 240 Minutes | |
| | Fluorouracil 50.0 mg/ml 0.5<br>mg/ml ≥ 240 Minutes | Fluorouracil 50.0 mg/ml 0.5<br>mg/ml ≥ 240 Minutes | |
| | Methotrexate 25 mg/ml ≥<br>240 Minutes | Methotrexate 25 mg/ml ≥<br>240 Minutes | |
| | Mitomycin C 0.5 mg/ml ≥<br>240 Minutes | Mitomycin C 0.5 mg/ml ≥<br>240 Minutes | |
| | Paclitaxel (Taxol) 6.0 mg/ml<br>≥ 240 Minutes | Paclitaxel (Taxol) 6.0 mg/ml<br>≥ 240 Minutes | |
| | Thio-Tepa 10.0 mg/ml 43.7<br>Minutes (Series 4000) or<br>37.5 Minutes (Series 5000) | Thio-Tepa 10.0 mg/ml 87.0<br>Minutes | |
| | | Vincristine Sulfate (Oncovin)<br>1.0 mg/ml ≥ 240 Minutes | |
| | | Please note that the<br>following drugs have low<br>permeation times:<br>Carmustine (BCNU) 3.3<br>mg/ml 25.8 Minutes | |
| | Subject Device: | Predicate Device: | |
| Device<br>Comparison | SafeSource Direct Blue<br>Powder-Free Nitrile Exam<br>Gloves | SafeSource Direct Blue<br>Powder-Free Nitrile Exam<br>Gloves K222898 | Comparison |
| | Vincristine Sulfate (Oncovin)<br>$1.0 mg/ml \ge 240 \text{ Minutes}$ | Thio-Tepa 10.0 mg/ml 43.7<br>Minutes | |
| | Please note that the<br>following drugs have low<br>permeation times:<br>Carmustine (BCNU)<br>3.3mg/ml 35.5 Minutes or<br>25.5 Minutes (Series 5000)<br>Thio-Tepa 10.0 mg/ml 43.7<br>Minutes (Series 4000) or<br>22.5 Minutes (Series 5000)<br>Warning: Not recommended<br>for use with these drugs. | Not recommended for use<br>with these drugs. | |
| Sizes | Series 4000: Extra Small,<br>Extra Extra Large<br>Series 5000: Extra Small,<br>Small, Medium, Large, Extra<br>Large, Extra Extra Large | Series 4000:<br>Small, Medium, Large, Extra<br>Large | Similar- the<br>subject device is<br>adding two<br>additional sizes<br>and another line<br>of gloves. |
| Materials | Nitrile | Nitrile | Similar |
| Color | Blue | Blue | Identical |
| Condition of Use | Single Use (Disposable) | Single Use (Disposable) | Identical |
| Powder or<br>Powder-Free | Powder free | Powder Free | Identical |
| Dimensions-<br>Length | Complies with ASTM D6319-<br>19 (both series)<br>XS: 220mm min<br>S: 220mm min<br>M: 230mm min<br>L: 230mm min<br>XL: 230mm min<br>XXL: 230mm min | Complies with ASTM D6319-<br>19<br>S: 220mm min<br>M: 230mm min<br>L: 230mm min<br>XL: 230mm min | Similar- both<br>follow the<br>standard |
| Dimensions-<br>Width | Complies with ASTM D6319-<br>19 (both series)<br>XS: 70±10mm<br>S: 80±10mm<br>M: 95±10mm<br>L: 110±10mm<br>XL: 120±10mm<br>XXL: 130±10mm | Complies with ASTM D6319-<br>19<br>S: 85±10mm<br>M: 95±10mm<br>L: 105±10mm<br>XL: 115±10mm | Similar- Both<br>comply with the<br>standard. |
| Dimensions-<br>Thickness | Complies with ASTM D6319-<br>19 | Complies with ASTM D6319-<br>19 | Identical |
| Device Comparison | Subject Device:<br>SafeSource Direct Blue<br>Powder-Free Nitrile Exam<br>Gloves | Predicate Device:<br>SafeSource Direct Blue<br>Powder-Free Nitrile Exam<br>Gloves K222898 | Comparison |
| | Palm - 0.05 minimum<br>Finger - 0.05 minimum | Palm - 0.05 minimum<br>Finger - 0.05 minimum | |
| Physical Properties<br>- Tensile Strength | Complies with ASTM D6319-<br>19<br>Tensile Strength:<br>Before Aging ≥14 MPa, min<br>After Aging ≥14 MPa, min | Complies with ASTM D6319-<br>19<br>Tensile Strength:<br>Before Aging ≥14 MPa, min<br>After Aging ≥14 MPa, min | Identical |
| Physical Properties<br>- Elongation | Elongation:<br>Before Aging 500% Min<br>After Aging 400% Min | Elongation:<br>Before Aging 500% Min<br>After Aging 400% Min | Identical |
| Freedom from<br>Holes | Complies with ASTM D6319-<br>19<br>and ASTM D5151-06 | Complies with ASTM D6319-<br>19<br>and ASTM D5151-06 G-1,<br>AQL<br>2.5 | Identical |
| Residual Powder | Max. 0.42mg per glove | Max. 0.42mg per glove | Identical |
| Biocompatibility | ISO 10993-10: Not a<br>skin irritant, not a<br>skin sensitizer<br>ISO 10993-5:<br>Cytotoxic<br>ISO 10993-11: No acute<br>systemic toxicity | ISO 10993-10: Not a<br>skin irritant, not a<br>skin sensitizer<br>ISO 10993-5:<br>Cytotoxic<br>ISO 10993-11: No acute<br>systemic toxicity | Identical |
| Sterility | Non-sterile | Non-sterile | Identical |
| Series 5000:<br>Chemotherapy<br>Drugs Tested with<br>Minimum<br>Breakthrough<br>Detection Time as<br>Tested per ASTM<br>D 6978 | Carmustine (BCNU) 3.3<br>mg/ml: 22.5 Minutes | Carmustine (BCNU) 3.3<br>mg/ml: 35.8 Minutes | Different- The<br>breakthrough<br>time was shorter<br>for the Series<br>5000 subject<br>device. |
| | Cisplatin 1.0 mg/ml: ≥240<br>Minutes | Cisplatin 1.0 mg/ml: ≥240<br>Minutes | Identical |
| | Cyclophosphamide<br>(Cytoxan) 20.0 mg/ml: ≥240<br>Minutes | Cyclophosphamide<br>(Cytoxan) 20.0 mg/ml: ≥240<br>Minutes | Identical |
| | Dacarbazine (DTIC) 10.0<br>mg/ml: ≥240 Minutes | Dacarbazine (DTIC) 10.0<br>mg/ml: ≥240 Minutes | Identical |
| | Doxorubicin Hydrochloride<br>2.0 mg/ml: ≥240 Minutes | Doxorubicin Hydrochloride<br>2.0 mg/ml: ≥240 Minutes | Identical |
| | Etoposide (Toposar) 20.0<br>mg/ml: ≥240 Minutes | Etoposide (Toposar) 20.0<br>mg/ml: ≥240 Minutes | Identical |
| | Fluorouracil 50.0 mg/ml:<br>≥240 Minutes | Fluorouracil 50.0 mg/ml:<br>≥240 Minutes | Identical |
| Methotrexate 25 mg/ml:<br>≥240 Minutes | Methotrexate 25 mg/ml:<br>≥240 Minutes | Identical | |
| Mitomycin C 0.5 mg/ml: ≥<br>240 Minutes | Mitomycin C 0.5 mg/ml: ≥<br>240 Minutes | Identical | |
| Paclitaxel (Taxol) 6.0 mg/ml:<br>≥240 Minutes | Paclitaxel (Taxol) 6.0 mg/ml:<br>≥240 Minutes | Identical | |
| Thio-Tepa 10.0 mg/ml: 37.5<br>Minutes | Thio-Tepa 10.0 mg/ml: 87.0<br>Minutes | Different- The<br>breakthrough<br>time was shorter<br>for the Series<br>5000 subject<br>device. | |
| Vincristine Sulfate (Oncovin)<br>1.0 mg/ml: ≥240 Minutes | Vincristine Sulfate (Oncovin)<br>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 Dimensions<br>Test | Length (mm):<br>XS/S: ≥ 220<br>M/L/XL/XXL: ≥ 230<br><br>Width (mm):<br>XS: 70 ± 10<br>S: 80 ± 10<br>M: 95 ± 10<br>L: 110 ± 10<br>XL: 120 ± 10<br>XXL: 130 ± 10<br><br>Thickness (mm):<br>Finger: ≥ 0.05<br>Palm: ≥ 0.05 | Length (mm):<br>XS/S: ≥ 220 / Pass<br>M/L/XL/XXL: ≥ 230 / Pass<br><br>Width (mm):<br>XS: 70 ± 10 / Pass<br>S: 80 ± 10 / Pass<br>M: 95 ± 10 / Pass<br>L: 110 ± 10 / Pass<br>XL: 120 ± 10 / Pass<br>XXL: 130 ± 10 / Pass<br><br>Thickness (mm):<br>Finger: 0.05 / Pass<br>Palm: 0.05 / Pass |
| ASTM D5151 | Watertightness Test for<br>Detection of Holes | Meet the requirements of ASTM<br>D5151 AQL 2.5 | Complies with ASTM D6319-<br>19 and ASTM D5151-06 |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM<br>D6124 < 2.0 mg<br>Meet the requirements of ASTM<br>D412 AQL 4.0 | 0.08-0.44 mg / Pass<br>Pass |
| ASTM D412 | Physical Properties | Before Aging<br>Tensile Strength ≥ 14 MPa<br>Ultimate Elongation ≥ 500% | 14 – 19 MPa<br>515 - 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 | | | | |
|--------------|----------------------------|--------------------------------------------|------------------------------------------------------------------|----------------------------------------------------------------------------------------------|--|--|--|------|
| | | After<br>Aging | Tensile Strength $\geq$ 14 MPa Ultimate Elongation $\geq$ 400% | | | | | Pass |
| | | | | | | | | |
| ISO 10993-11 | Acute Systemic<br>Toxicity | Non-Acute Systemic Toxicity | | Under conditions of the<br>study, did not show acute<br>systemic toxicity in vivo. /<br>Pass | | | | |
| ISO 10993-10 | Irritation | Non-irritating | | Under conditions of the<br>study, not an irritant. / Pass | | | | |
| ISO 10993-10 | Sensitization | Non-sensitizing | | Under conditions of the<br>study, not a sensitizer. /<br>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.