(27 days)
No
The device is a disposable examination glove, and the summary focuses on physical properties, biocompatibility, and chemotherapy drug resistance testing, with no mention of AI or ML.
No
The device is a patient examination glove, intended to prevent contamination between patient and examiner, not to provide therapy.
No
The device is a glove intended to prevent contamination between patient and examiner, not to diagnose a condition or disease.
No
The device is a physical examination glove, which is a hardware medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "patient examination glove... worn on the examiner's hands to prevent contamination between patient and examiner." This is a barrier device used externally.
- Device Description: The description reinforces the intended use as a glove for preventing contamination.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose, monitor, or screen for any disease or condition using samples from the human body (like blood, urine, tissue, etc.).
- Performance Studies: The performance studies focus on the physical properties and barrier function of the glove (watertightness, tensile strength, biocompatibility, chemotherapy drug resistance), not on any diagnostic accuracy or analytical performance related to biological samples.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This glove does not fit that description.
N/A
Intended Use / Indications for 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.
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.
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.
Product codes
LZA, LZC, OPJ
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 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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Data
Test Method: ASTM D6319
Purpose: Physical Dimensions Test
Acceptance Criteria: Length (mm): XS/S: >= 220, M/L/XL/XXL: >= 230; Width (mm): XS: 70 +/- 10, S: 80 +/- 10, M: 95 +/- 10, L: 110 +/- 10, XL: 120 +/- 10, XXL: 130 +/- 10; Thickness (mm): Finger: >= 0.05, Palm: >= 0.05
Results: Length (mm): XS/S: >= 220 / Pass, M/L/XL/XXL: >= 230 / Pass; Width (mm): XS: 70 +/- 10 / Pass, S: 80 +/- 10 / Pass, M: 95 +/- 10 / Pass, L: 110 +/- 10 / Pass, XL: 120 +/- 10 / Pass, XXL: 130 +/- 10 / Pass; Thickness (mm): Finger: 0.05 / Pass, Palm: 0.05 / Pass
Test Method: ASTM D5151
Purpose: Watertightness Test for Detection of Holes
Acceptance Criteria: Meet the requirements of ASTM D5151 AQL 2.5
Results: Complies with ASTM D6319-19 and ASTM D5151-06
Test Method: ASTM D6124
Purpose: Powder Content
Acceptance Criteria: Meet the requirements of ASTM D6124 = 14 MPa, Ultimate Elongation >= 500%; After Aging: Tensile Strength >= 14 MPa Ultimate Elongation >= 400%
Results: 14 – 19 MPa, 515 - 540% Pass
Test Method: ISO 10993-11
Purpose: Acute Systemic Toxicity
Acceptance Criteria: Non-Acute Systemic Toxicity
Results: Under conditions of the study, did not show acute systemic toxicity in vivo. / Pass
Test Method: ISO 10993-10
Purpose: Irritation
Acceptance Criteria: Non-irritating
Results: Under conditions of the study, not an irritant. / Pass
Test Method: ISO 10993-10
Purpose: Sensitization
Acceptance Criteria: Non-sensitizing
Results: Under conditions of the study, 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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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, LLC
200 St Nazaire Rd.
Broussard, LA 70518
Sponsor Contact: Justin Hollingsworth |
|---------------------|-----------------------------------------------------------------------------------------------------------------|
| Submission Contact: | Grace Powers, MS, MBA, RAC
Founder/Principal Consultant
Powers Regulatory Consulting
Tel: 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 Exam
Gloves | Powder-Free Nitrile Exam
Gloves K222898 | Comparison |
| Name | SafeSource Direct Blue
Powder-Free Nitrile Exam
Gloves | SafeSource Direct Blue
Powder-Free Nitrile Exam
Gloves | Identical |
| Manufacturer | SafeSource Direct, LLC | SafeSource Direct, LLC | Identical |
| FDA Product Code | LZA, LZC, OPJ | LZA, LZC | Identical |
| Regulation Name | Polymer Patient
Examination Glove, Patient
Examination Glove, Specialty | Polymer Patient
Examination Glove, Patient
Examination Glove, Specialty | Identical |
| Regulation
Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Identical |
| Intended Use/
Indications for Use | A patient examination glove
is a disposable device
intended for medical | A patient examination glove
is a disposable device
intended for medical | The device name
has been
updated to |
| Device Comparison | Subject Device:
SafeSource Direct Blue
Powder-Free Nitrile Exam
Gloves | Predicate Device:
SafeSource Direct Blue
Powder-Free Nitrile Exam
Gloves K222898 | Comparison |
| | 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. | 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
| differentiate the
two lines of
gloves. |
| | Carmustine (BCNU) 3.3
mg/ml 35.8 Minutes (Series
4000) or 22.5 Minutes
(Series 5000) | Carmustine (BCNU) 3.3
mg/ml 35.8 Minutes | The
breakthrough
time information
is identical with
the exception of
the Carmustine
and Thio-Tepa
breakthrough
times for the
Series 5000
gloves. |
| | Cisplatin 1.0 mg/ml ≥ 240
Minutes | Cisplatin 1.0 mg/ml ≥ 240
Minutes | |
| | Cyclophosphamide
(Cytoxan) 20.0 mg/ml ≥ 240
Minutes | Cyclophosphamide
(Cytoxan) 20.0 mg/ml ≥ 240
Minutes | |
| | Dacarbazine (DTIC) 10.0
mg/ml ≥ 240 Minutes | Dacarbazine (DTIC) 10.0
mg/ml ≥ 240 Minutes | |
| | Doxorubicin Hydrochloride
2.0 mg/ml ≥ 240 Minutes | Doxorubicin Hydrochloride
2.0 mg/ml ≥ 240 Minutes | |
| | Etoposide (Toposar) 20.0
mg/ml ≥ 240 Minutes | Etoposide (Toposar) 20.0
mg/ml ≥ 240 Minutes | |
| | Fluorouracil 50.0 mg/ml 0.5
mg/ml ≥ 240 Minutes | Fluorouracil 50.0 mg/ml 0.5
mg/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 43.7
Minutes (Series 4000) or
37.5 Minutes (Series 5000) | 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 25.8 Minutes | |
| | Subject Device: | Predicate Device: | |
| Device
Comparison | SafeSource Direct Blue
Powder-Free Nitrile Exam
Gloves | SafeSource Direct Blue
Powder-Free Nitrile Exam
Gloves K222898 | Comparison |
| | Vincristine Sulfate (Oncovin)
$1.0 mg/ml \ge 240 \text{ Minutes}$ | Thio-Tepa 10.0 mg/ml 43.7
Minutes | |
| | Please note that the
following drugs have low
permeation times:
Carmustine (BCNU)
3.3mg/ml 35.5 Minutes or
25.5 Minutes (Series 5000)
Thio-Tepa 10.0 mg/ml 43.7
Minutes (Series 4000) or
22.5 Minutes (Series 5000)
Warning: Not recommended
for use with these drugs. | Not recommended for use
with these drugs. | |
| Sizes | Series 4000: Extra Small,
Extra Extra Large
Series 5000: Extra Small,
Small, Medium, Large, Extra
Large, Extra Extra Large | Series 4000:
Small, Medium, Large, Extra
Large | Similar- the
subject device is
adding two
additional sizes
and another line
of gloves. |
| Materials | Nitrile | Nitrile | Similar |
| Color | Blue | Blue | Identical |
| Condition of Use | Single Use (Disposable) | Single Use (Disposable) | Identical |
| Powder or
Powder-Free | Powder free | Powder Free | Identical |
| Dimensions-
Length | Complies with ASTM D6319-
19 (both series)
XS: 220mm min
S: 220mm min
M: 230mm min
L: 230mm min
XL: 230mm min
XXL: 230mm min | Complies with ASTM D6319-
19
S: 220mm min
M: 230mm min
L: 230mm min
XL: 230mm min | Similar- both
follow the
standard |
| Dimensions-
Width | Complies with ASTM D6319-
19 (both series)
XS: 70±10mm
S: 80±10mm
M: 95±10mm
L: 110±10mm
XL: 120±10mm
XXL: 130±10mm | Complies with ASTM D6319-
19
S: 85±10mm
M: 95±10mm
L: 105±10mm
XL: 115±10mm | Similar- Both
comply with the
standard. |
| Dimensions-
Thickness | Complies with ASTM D6319-
19 | Complies with ASTM D6319-
19 | Identical |
| Device Comparison | Subject Device:
SafeSource Direct Blue
Powder-Free Nitrile Exam
Gloves | Predicate Device:
SafeSource Direct Blue
Powder-Free Nitrile Exam
Gloves K222898 | Comparison |
| | Palm - 0.05 minimum
Finger - 0.05 minimum | Palm - 0.05 minimum
Finger - 0.05 minimum | |
| Physical Properties
- Tensile Strength | Complies with ASTM D6319-
19
Tensile Strength:
Before Aging ≥14 MPa, min
After Aging ≥14 MPa, min | Complies with ASTM D6319-
19
Tensile Strength:
Before Aging ≥14 MPa, min
After Aging ≥14 MPa, min | Identical |
| Physical Properties - Elongation | Elongation:
Before Aging 500% Min
After Aging 400% Min | Elongation:
Before Aging 500% Min
After Aging 400% Min | Identical |
| Freedom from
Holes | Complies with ASTM D6319-
19
and ASTM D5151-06 | Complies with ASTM D6319-
19
and ASTM D5151-06 G-1,
AQL
2.5 | Identical |
| Residual Powder | Max. 0.42mg per glove | Max. 0.42mg per glove | Identical |
| Biocompatibility | ISO 10993-10: Not a
skin irritant, not a
skin sensitizer
ISO 10993-5:
Cytotoxic
ISO 10993-11: No acute
systemic toxicity | ISO 10993-10: Not a
skin irritant, not a
skin sensitizer
ISO 10993-5:
Cytotoxic
ISO 10993-11: No acute
systemic toxicity | Identical |
| Sterility | Non-sterile | Non-sterile | Identical |
| Series 5000:
Chemotherapy
Drugs Tested with
Minimum
Breakthrough
Detection Time as
Tested per ASTM
D 6978 | Carmustine (BCNU) 3.3
mg/ml: 22.5 Minutes | Carmustine (BCNU) 3.3
mg/ml: 35.8 Minutes | Different- The
breakthrough
time was shorter
for the Series
5000 subject
device. |
| | Cisplatin 1.0 mg/ml: ≥240
Minutes | Cisplatin 1.0 mg/ml: ≥240
Minutes | Identical |
| | Cyclophosphamide
(Cytoxan) 20.0 mg/ml: ≥240
Minutes | Cyclophosphamide
(Cytoxan) 20.0 mg/ml: ≥240
Minutes | Identical |
| | Dacarbazine (DTIC) 10.0
mg/ml: ≥240 Minutes | Dacarbazine (DTIC) 10.0
mg/ml: ≥240 Minutes | Identical |
| | Doxorubicin Hydrochloride
2.0 mg/ml: ≥240 Minutes | Doxorubicin Hydrochloride
2.0 mg/ml: ≥240 Minutes | Identical |
| | Etoposide (Toposar) 20.0
mg/ml: ≥240 Minutes | Etoposide (Toposar) 20.0
mg/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: 37.5
Minutes | Thio-Tepa 10.0 mg/ml: 87.0
Minutes | Different- The
breakthrough
time was shorter
for the Series
5000 subject
device. | |
| 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 Dimensions | ||
| Test | Length (mm): | ||
| XS/S: ≥ 220 | |||
| M/L/XL/XXL: ≥ 230 |
Width (mm):
XS: 70 ± 10
S: 80 ± 10
M: 95 ± 10
L: 110 ± 10
XL: 120 ± 10
XXL: 130 ± 10
Thickness (mm):
Finger: ≥ 0.05
Palm: ≥ 0.05 | Length (mm):
XS/S: ≥ 220 / Pass
M/L/XL/XXL: ≥ 230 / Pass
Width (mm):
XS: 70 ± 10 / Pass
S: 80 ± 10 / Pass
M: 95 ± 10 / Pass
L: 110 ± 10 / Pass
XL: 120 ± 10 / Pass
XXL: 130 ± 10 / Pass
Thickness (mm):
Finger: 0.05 / Pass
Palm: 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 |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM
D6124