MemorialTM Gloves
Device Facts
| Record ID | K231740 |
|---|---|
| Device Name | MemorialTM Gloves |
| Applicant | Us Glove Supply |
| Product Code | LZA · General Hospital |
| Decision Date | Jul 4, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6250 |
| Device Class | Class 1 |
| Attributes | 3rd-Party Reviewed |
Indications for Use
These Powder Free, Nitrile Examination Gloves are a disposable device intended for medical purpose 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 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
Device Story
Disposable, non-sterile, ambidextrous nitrile examination gloves; blue, polymer-coated, finger-textured, beaded cuff. Used by clinicians in hospitals, clinics, and home-care to prevent cross-contamination. Tested for resistance to chemotherapy drug permeation per ASTM D6978-05. Input: physical barrier requirement during patient examination. Output: protective barrier. Healthcare providers wear gloves during patient contact; output is the prevention of contamination. Benefits: protects both patient and examiner from biological contaminants and specific chemotherapy agents.
Clinical Evidence
No clinical data. Bench testing only. Performance verified via ASTM D6319-19 (dimensions, physical properties, freedom from holes, powder content) and ASTM D6978-05 (chemotherapy drug permeation). Biocompatibility testing per ISO 10993-5, 10, 11, and 23 confirmed the device is non-irritating, non-sensitizing, and non-cytotoxic at tested concentrations.
Technological Characteristics
Material: 100% synthetic Nitrile Butadiene Latex. Surface: polymer-coated, finger-textured, beaded cuff. Dimensions: length min 230mm. Standards: ASTM D6319-19, ASTM D6978-05, ASTM D5151-19, ASTM D6124. Non-sterile, single-use, powder-free. No software or electronic components.
Indications for Use
Indicated for use by adults in medical settings (hospitals, dental clinics, chemotherapy centers, home-care) as a disposable barrier to prevent cross-contamination between patient and examiner. Not for use with Carmustine or Thio-Tepa.
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
- Blue Non-Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs (K172525)
Reference Devices
- Nephron Nitrile (K223559)
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 4, 2023
US Glove Supply % Prithul Bom Accredited Person, Reviewer Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K231740
Trade/Device Name: Memorial™ Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I. reserved Product Code: LZA, LZC, OPJ Dated: June 14, 2023 Received: June 14, 2023
Dear Prithul Bom:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
# Bifeng Qian -S
Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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# Indications for Use
510(k) Number (if known)
### K231740
Device Name
Memorialтм Gloves
### Indications for Use (Describe)
These Powder Free, Nitrile Examination Gloves are a disposable device intended for medical purpose 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 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
Chemotherapy Drug Permeation
The following chemicals have been tested with these gloves:
| Tested Chemotherapy Drug and Concentration | Minimum Breakthrough Detection time |
|--------------------------------------------|---------------------------------------|
| Cyclophosphamide (20.0 mg/ml) | No breakthrough for up to 240 minutes |
| Doxorubicin Hydrochloride (2.0 mg/ml) | No breakthrough for up to 240 minutes |
| Etoposide (20.0 mg/ml) | No breakthrough for up to 240 minutes |
| 5-Fluorouracil (50.0 mg/ml) | No breakthrough for up to 240 minutes |
| Paclitaxel (Taxol) (6.0 mg/ml) | No breakthrough for up to 240 minutes |
| Cisplatin (1.0 mg/ml) | No breakthrough for up to 240 minutes |
| Dacarbazine (10.0 mg/ml) | No breakthrough for up to 240 minutes |
| Methotrexate (25 mg/ml) | No breakthrough for up to 240 minutes |
| Mitomycin C (0.5 mg/ml) | No breakthrough for up to 240 minutes |
| Vincristine Sulfate (1.0 mg/ml) | No breakthrough for up to 240 minutes |
| Carmustine (BCNU) (3.3 mg/ml) | Min minutes before breakthrough =14.9 |
| Thio-Tepa (10.0 mg/ml) | Min minutes before breakthrough =37.8 |
Warning Not For use with Carmustine
Warning Not For use with Thio-Tepa
*Please note that the following drugs have low permeation times:
Carmustine (BCNU): 14.9 Minutes and Thio-Tepa: 37.8 Minutes
Type of Use (Select one or both, as applicable)
| <div role="checkbox"></div> Prescription Use (Part 21 CFR 801 Subpart D) | <div aria-checked="true" role="checkbox">X</div> Over-The-Counter Use (21 CFR 801 Subpart C) |
|--------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
|--------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
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Powder Free, Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)
# 510 (k) Summary - K231740
#### 5.1 Submission Sponsor Information
US Glove Supply 300 Commerce Drive, Buffalo NY, 14218 United States Cell Phone Number: 516-456-3642 E-mail: jacomo@glovesupply.us Website: www.glovesupply.us Primary Contact: Mr Jacomo Hakim Secondary Contact: Rose Robbins E-mail: Rose@glovesupply.us Cell Phone Number:212-771-8822
#### 5.2 Date Prepared
6/29/2023
#### 5.3 Device Identification
| Trade/Proprietary Name | MemorialTM Gloves |
|------------------------|-------------------------------------------------------------------------------------|
| Common Name | Powder Free, Nitrile Examination Gloves (Tested for Use<br>with Chemotherapy Drugs) |
| Classification Name | Non-Powdered Patient Examination Glove Specialty |
| Regulation Number | 21 CFR 880.6250 |
| Product Code | LZC, LZA, OPJ |
| Device Class | Class I, reserved |
| Classification Panel | General Hospital and Personal Use Devices |
#### Legally marketed device(s) to which equivalence is claimed 5.4
### Predicate Device:
| 510(k) | K172525 |
|------------------------|---------------------------------------------------------|
| Trade/Proprietary Name | Blue Non-Sterile Powder Free Nitrile Examination Gloves |
| | Tested for Use with Chemotherapy Drugs |
| Common Name | Chemotherapy Gloves, Exam Gloves |
| Classification Name | Patient Examination Gloves Specialty |
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| Regulation Number | 21 CFR 880.6250 |
|----------------------|-------------------------------------------|
| Product Code | LZC, LZA |
| Device Class | Class I |
| Classification Panel | General Hospital and Personal Use Devices |
### Reference device:
| 510(k) | K223559 |
|------------------------|------------------------------------------------------------------------|
| Trade/Proprietary Name | Nephron Nitrile |
| Common Name | Nitrile Examination Gloves (Tested for Use with<br>Chemotherapy drugs) |
| Classification Name | Non-Powdered Patient Examination Glove Specialty |
| Regulation Number | 21 CFR 880.6250 |
| Product Code | LZC, LZA, OPJ |
| Device Class | Class I, reserved |
| Classification Panel | General Hospital and Personal Use Devices |
#### ર્ રંડ Device Description
US Glove Supply's Powder Free, Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) are Blue, Polymer coated, Nonsterile, Powder Free, Ambidextrous Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs. These are made up of 100% synthetic Nitrile Butadiene Latex. Its surface finish is finger textured with beaded cuff.
The device is designed and tested as per its device specific guidance; "Medical Glove Guidance Manual".
Image /page/5/Picture/7 description: The image shows two blue nitrile gloves. The gloves are clean and appear to be new. The gloves are positioned side by side, with the fingers pointing upwards. The gloves are likely intended for medical or industrial use.
Figure 5.1: US Glove Supply's Powder Free, Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)
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Over the counter use: Yes
Single use disposable device: Yes
Sterile: No
User Profile/Population: Adults
### Use Environment:
- Examination and Medical (Hospitals, Dental Clinics, Chemotherapy Centers, Home-care -Centers)
#### Indications for Use 5.6
These Powder Free, Nitrile Examination Gloves are a disposable device intended for medical purpose 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 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
### Chemotherapy Drug Permeation
The following chemicals have been tested with these gloves:
| Tested Chemotherapy Drug and<br>Concentration | Minimum Breakthrough Detection Time |
|-----------------------------------------------|---------------------------------------|
| Carmustine (BCNU) 3.3 mg/ml | Min minutes before breakthrough =14.9 |
| Cyclophosphamide 20.0 mg/ml | No breakthrough for up to 240 minutes |
| Cisplatin (1.0 mg/ml) | No breakthrough for up to 240 minutes |
| Dacarbazine 10.0 mg/ml | No breakthrough for up to 240 minutes |
| Doxorubicin Hydrochloride 2.0 mg/ml | No breakthrough for up to 240 minutes |
| Etoposide 20.0 mg/ml | No breakthrough for up to 240 minutes |
| Fluorouracil 50.0 mg/ml | No breakthrough for up to 240 minutes |
| Methotrexate 25 mg/ml | No breakthrough for up to 240 minutes |
| Mitomycin C 0.5 mg/ml | No breakthrough for up to 240 minutes |
| Paclitaxel (Taxol) 6.0 mg/ml | No breakthrough for up to 240 minutes |
| Thio-Tepa 10.0 mg/ml | Min minutes before breakthrough =37.8 |
| Vincristine Sulfate 1.0 mg/ml | No breakthrough for up to 240 minutes |
*Please note that the following drugs have low permeation times: Carmustine (BCNU): 14.9 Minutes and Thio-Tepa: 37.8 Minutes Warning: Not for use with Carmustine (BCNU) and Thio-Tepa.
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#### 5.7 Comparison of the technological characteristics with the predicate device
The comparison chart below provides evidence to facilitate the substantial equivalence determination between US Glove Supply Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) and the predicate device (K172525) & with reference device (K223559) with respect to the intended use, technological characteristics, and principles of operation.
Reference device (K223559) has been included in the 510K to support substantial equivalence with respect to the use of additionally claimed chemotherapy drugs than that of Predicate device.
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Powder Free, Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)
| Comparison<br>parameters | STANDARDS | (Proposed Device) | (Predicate Device) | (Reference device) | Comparison |
|-----------------------------------------------------------------------------------|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| 510(K)Number | -- | K231740 | K172525 | K223559 | Different |
| Manufacturer<br>Name | -- | US Glove Supply | Central Medicare SDN. BHD | Nephron Pharmaceuticals<br>Corporation | Different |
| Name of device | -- | Powder Free, Nitrile<br>Examination Gloves (Tested<br>for Use with Chemotherapy<br>Drugs) | Blue Non-Sterile Powder Free<br>Nitrile Examination Gloves Tested<br>for Use with Chemotherapy Drugs | Nephron Nitrile Powder-Free<br>Nitrile Examination Gloves<br>(Tested for Use with<br>Chemotherapy Drugs) | Different |
| Product Code | -- | LZC, LZA, OPJ | LZA, LZC | LZA, LZC, OPJ | Same with<br>Predicate<br>Device |
| Indication for<br>use | -- | These Powder Free, Nitrile<br>Examination Gloves are a<br>disposable device intended for<br>medical purpose that is worn<br>on the examiner's hands to<br>prevent contamination<br>between patient and examiner.<br>These gloves were tested for<br>use with chemotherapy drugs<br>as per ASTM D6978-05<br>Standard Practice for<br>Assessment of Resistance of<br>Medical Gloves to Permeation<br>by Chemotherapy Drugs. | Blue Non-Sterile Powder Free<br>Nitrile Examination Gloves Tested<br>for Use with Chemotherapy Drugs<br>is a disposable device intended for<br>medical purposes that is worn on<br>the examiner's hand to prevent<br>contamination between patient and<br>examiner.<br>Gloves have been tested for use<br>with chemotherapy drugs using<br>ASTM D6978-05 and will be<br>labelled with a statement of<br>compliance and a summary of the<br>testing results | Nephron Nitrile Powder-Free<br>Nitrile Examination Gloves<br>(Tested for Use with<br>Chemotherapy Drugs) is a<br>disposable device intended for<br>medical purpose that is worn on<br>the examiner's hand to prevent<br>contamination between patient<br>and examiner. In addition, these<br>gloves were tested for use with<br>chemotherapy drugs in<br>accordance with ASTM<br>D6978-05 (2019) Standard<br>Practice for Assessment of<br>Resistance of Medical Gloves<br>to Permeation by<br>Chemotherapy Drugs. | Similar;<br>difference in<br>terminology |
| Regulation<br>Number | -- | 21 CFR 880.6250 | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Material | -- | Nitrile | Nitrile | Nitrile | Same |
| Colour | -- | Blue | Blue | Blue | Same |
| Size | -- | Small, Medium, Large, X Large | Extra Small, Small, Medium, Large, Extra Large | M, L, XL, XXL | Similar; predicate device has additional sizes |
| Single use | -- | Single use | Single use | Single use | Same |
| Sterile/non sterile | -- | Non-sterile | Non-sterile | Non-sterile | Same |
| Rx Only or OTC | -- | OTC | OTC | OTC | Same |
| Dimensions - Length | ASTM D6319-2019 | Minimum 230 | Minimum 230 | Minimum 230 | Same |
| Dimensions - Width | ASTM D6319-2019 | S 80<br>M 95<br>L 110<br>XL 120 | XS 70<br>S 80<br>M 95<br>L 110<br>XL 120 | M 95<br>L 113<br>XL 121<br>XXL 129 | Same |
| Physical Properties<br>Tensile Strength | ASTM D6319-2019 | Before aging: 14MPa, min<br>After aging: 14MPa, min | | Before aging: 14MPa, min<br>After aging: 14MPa, min | Same |
| Physical Properties<br>Ultimate Elongation | ASTM D6319-2019 | Before aging: 500%, min<br>After aging: 400%, min | | Before aging: 500%, min<br>After aging: 400%, min | Same |
| Thickness (mm) | ASTM D6319-19 | Cuff: 0.05 ± 0.02<br>Palm: 0.07 ± 0.02<br>Finger: 0.09 ± 0.02 | | Cuff: 0.06 ± 0.03<br>Palm: 0.08 ± 0.03<br>Finger: 0.10 ± 0.03 | Similar; meets ASTM D6319 -19 requirements |
| Powder Free<br>Residue | ASTM<br>D6319-19 | Max 1.38 mg/glove | Max. 0.52 mg per glove | < 2 mg per glove Average<br>value = 0.3516 mg/glove<br>(Medium) | Similar,<br>meets the<br>standard<br>ASTM<br>D6124<br>requirement<br>of maximum<br>2.0 mg |
| Freedom from<br>holes | ASTM D5151-<br>2019 | Meets with the requirement of<br>ASTM D 5151, following<br>ASTM D 6319 AQL<br>2.5/Inspection Level G-I | Meets with the requirement of<br>ASTM D 5151, following<br>ASTM D 6319 AQL<br>2.5/Inspection Level G-I | In accordance with<br>ASTM D 5151-19,<br>following ASTM<br>D6319- 19,<br>G-I, AQL 2.5 | Same |
| Chemotherapy<br>Drugs<br>Tested with<br>Minimum<br>Breakthrough<br>Detection Time | ASTM D6978-<br>05 (2019) | Carmustine (3.3mg/ml)<br>Min minutes<br>before breakthrough =14.9 | Carmustine (3.3mg/ml)<br>Min minutes before breakthrough<br>=12.4 | Carmustine (3.3mg/ml)<br>Min minutes<br>before breakthrough =33.8 | Similar |
| | | Cisplatin (1.0 mg/ml)<br>No breakthrough for up to<br>240minutes | Cisplatin (1.0 mg/ml)<br>No breakthrough for up to<br>240minutes | Cisplatin (1.0 mg/ml)<br>No breakthrough for up to<br>240minutes | Same |
| | | Cyclophosphamide (20mg/ml)<br>No breakthrough for up to<br>240minutes | Cyclophosphamide (20mg/ml)<br>No breakthrough for up to<br>240minutes | Cyclophosphamide (20mg/ml)<br>No breakthrough for up to<br>240minutes | Same |
| | | Dacarbazine (10.0 mg/ml)<br>No breakthrough for up to<br>240minutes | Dacarbazine (10.0 mg/ml)<br>No breakthrough for up to<br>240minutes | Dacarbazine (10.0 mg/ml)<br>No breakthrough for up to<br>240minutes | Same |
| | | Doxorubicin HCI (2.0mg/ml)<br>No breakthrough for up to<br>240minutes | Doxorubicin HCI (2.0mg/ml)<br>No breakthrough for up to<br>240minutes | Doxorubicin HCI (2.0mg/ml)<br>No breakthrough for up to<br>240minutes | Same |
| | | Etoposide (20.0 mg/ml)<br>No breakthrough for up to<br>240minutes | Etoposide (20.0 mg/ml)<br>No breakthrough for up to<br>240minutes | Etoposide (20.0 mg/ml)<br>No breakthrough for up to<br>240minutes | Same |
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Powder Free, Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)
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| Fluorouracil (50.0 mg/ml)<br>No breakthrough for up to<br>240minutes | Fluorouracil (50.0 mg/ml)<br>No breakthrough for up to<br>240minutes | Fluorouracil (50.0 mg/ml)<br>No breakthrough for up to<br>240minutes | Same |
|---------------------------------------------------------------------------|---------------------------------------------------------------------------|----------------------------------------------------------------------------|----------------------------------------------|
| Methotrexate (25.0 mg/ml)<br>No breakthrough for up to<br>240minutes | Not tested | Methotrexate (25.0 mg/ml)<br>No breakthrough for up to<br>240minutes | *Same as<br>Reference<br>Predicate<br>Device |
| Mitomycin C (0.5 mg/ml)<br>No breakthrough for up to<br>240minutes | Not tested | Mitomycin C (0.5 mg/ml)<br>No breakthrough for up to<br>240minutes | *Same as<br>Reference<br>Predicate<br>Device |
| Paclitaxel (6.0 mg/ml)<br>No breakthrough for up to<br>240minutes | Paclitaxel (6.0 mg/ml)<br>No breakthrough for up to<br>240minutes | Paclitaxel (6.0 mg/ml)<br>No breakthrough for up to<br>240minutes | Same |
| Thiotepa (10.0 mg/ml)<br>Min minutes before<br>breakthrough =37.8 | Thiotepa (10.0 mg/ml)<br>Min minutes before<br>breakthrough =4.4 | Thiotepa (10.0 mg/ml)<br>Min minutes before<br>breakthrough =128.1 | Similar |
| Vincristine Sulfate (1.0mg/ml)<br>No breakthrough for up to<br>240minutes | Vincristine Sulfate (1.0mg/ml)<br>No breakthrough for up to<br>240minutes | Vincristine Sulfate (1.0mg/ml)<br>No breakthrough for up to<br>240minutes | Same |
| Ifosfamide (50.0 mg/ml)<br>Not tested | Ifosfamide (50.0 mg/ml)<br>No breakthrough for up to<br>240minutes | Ifosfamide (50.0 mg/ml)<br>No breakthrough for up to<br>240minutes | *Will not be<br>claimed by<br>US Gloves |
| Mitoxantrone (2.0 mg/ml)<br>Not tested | Mitoxantrone (2.0 mg/ml)<br>No breakthrough for up to<br>240minutes | Mitoxantrone (2.0 mg/ml)<br>No breakthrough for up to<br>240minutes | *Will not be<br>claimed by<br>US Gloves |
| Mechlorethamine HCL<br>(1.0<br>mg/ml)<br>Not tested | Mechlorethamine HCL<br>(1.0<br>mg/ml)<br>Not tested | Mechlorethamine HCL<br>(1.0 mg/ml)<br>Not tested | *Will not be<br>claimed by<br>US Gloves |
| Irinotecan (20.0 mg/ml)<br>Not tested | Irinotecan (20.0 mg/ml)<br>Not tested | Irinotecan (20.0 mg/ml)<br>No breakthrough for up to<br>240minutes | *Will not be<br>claimed by<br>US Gloves |
| Carboplatin (10.0 mg/ml)<br>Not tested | Carboplatin (10.0 mg/ml)<br>Not tested | Carboplatin (10.0 mg/ml)<br>No breakthrough for up to<br>240minutes | *Will not be<br>claimed by<br>US Gloves |
| Docetaxel (10.0 mg/ml)<br>Not tested | Docetaxel (10.0 mg/ml)<br>Not tested | Docetaxel (10.0 mg/ml)<br>Not tested | *Will not be<br>claimed by<br>US Gloves |
| Bleomycin Sulfate<br>(15 mg/ml)<br>Not Tested | Bleomycin Sulfate<br>(15 mg/ml)<br>Not Tested | Bleomycin Sulfate<br>(15 mg/ml)<br>No breakthrough for up to<br>240minutes | *Will not be<br>claimed by<br>US Gloves |
| Busulfan (6 mg/ml)<br>Not tested | Busulfan (6 mg/ml)<br>Not tested | Busulfan (6 mg/ml)<br>No breakthrough for up to<br>240minutes | *Will not be<br>claimed by<br>US Gloves |
| Chloroquine 50mg/ml<br>Not tested | Chloroquine<br>50mg/ml<br>Not tested | Chloroquine<br>50mg/ml<br>Not tested | *Will not be<br>claimed by<br>US Gloves |
| Cyclosporin 100 mg/ml<br>Not tested | Cyclosporin 100 mg/ml<br>Not tested | Cyclosporin 100 mg/ml<br>Not tested | *Will not be<br>claimed by<br>US Gloves |
| Cytarabine HCL 100 mg/ml<br>Not tested | Cytarabine HCL 100 mg/ml<br>Not tested | Cytarabine HCL 100 mg/ml<br>Not tested | *Will not be<br>claimed by<br>US Gloves |
| Cytarabine 100 mg/ml<br>Not tested | Cytarabine 100 mg/ml<br>Not tested | Cytarabine 100 mg/ml<br>No breakthrough for up to<br>240minutes | *Will not be<br>claimed by<br>US Gloves |
| Daunorubicin HCl<br>5 mg/ml<br>Not tested | Daunorubicin HCl<br>5 mg/ml<br>Not tested | Daunorubicin HCl<br>5 mg/ml<br>No breakthrough for up to<br>240minutes | *Will not be<br>claimed by<br>US Gloves |
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| | Docetaxel HCL 10 mg/ml<br>Not tested | Docetaxel HCL 10 mg/ml<br>Not tested | Docetaxel HCL 10 mg/ml<br>Not tested | *Will not be<br>claimed by<br>US Gloves | |
|---------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|------|
| | Docetaxel 10 mg/ml<br>Not tested | Docetaxel 10 mg/ml<br>Not tested | Docetaxel 10 mg/ml<br>No breakthrough for up to<br>240minutes | *Will not be<br>claimed by<br>US Gloves | |
| | Epirubicin HCl 2 mg/ml<br>Not tested | Epirubicin HCl 2 mg/ml<br>Not tested | Epirubicin HCl 2 mg/ml<br>No breakthrough for up to<br>240minutes | *Will not be<br>claimed by<br>US Gloves | |
| | Fludarabine 25 mg/ml<br>Not tested | Fludarabine 25 mg/ml<br>Not tested | Fludarabine 25 mg/ml<br>No breakthrough for up to<br>240minutes | *Will not be<br>claimed by<br>US Gloves | |
| | Gemcitabine 38 mg/ml<br>Not tested | Gemcitabine 38 mg/ml<br>Not tested | Gemcitabine 38 mg/ml<br>No breakthrough for up to<br>240minutes | *Will not be<br>claimed by<br>US Gloves | |
| | Idarubicin HCl 1 mg/ml<br>Not tested | Idarubicin HCl 1 mg/ml<br>Not tested | Idarubicin HCl 1 mg/ml<br>No breakthrough for up to<br>240minutes | *Will not be<br>claimed by<br>US Gloves | |
| | Melphalan 5 mg/ml<br>Not tested | Melphalan 5 mg/ml<br>Not tested | Melphalan 5 mg/ml<br>No breakthrough for up to<br>240minutes | *Will not be<br>claimed by<br>US Gloves | |
| | Rituximab 10 mg/ml<br>Not tested | Rituximab 10 mg/ml<br>Not tested | Rituximab 10 mg/ml<br>No breakthrough for up to<br>240minutes | *Will not be<br>claimed by<br>US Gloves | |
| | Trisenox 1 mg/ml<br>Not tested | Trisenox 1 mg/ml<br>Not tested | Trisenox 1 mg/ml<br>No breakthrough for up to<br>240minutes | *Will not be<br>claimed by<br>US Gloves | |
| Biocompatibility | Primary skin<br>irritation- ISO<br>10993 Part<br>23:2021 | Under the conditions of the<br>study, not an irritant | Under the conditions of the study,<br>not an irritant | Under the conditions of the<br>study, not an irritant | Same |
| | Dermal<br>Sensitization- | Under the conditions of the<br>study, not a sensitizer | Under the conditions of the study,<br>not a sensitizer | Under the conditions of the<br>study, not a sensitizer | Same |
| | | | | | |
| ISO 10993-<br>10:2021 | | --- | | | |
| In vitro<br>Cytotoxicity-<br>ISO 10993-5:<br>2009 | Based on the results obtained<br>under laboratory testing<br>conditions, test item extracts of<br>Nitrile Examination Gloves was<br>found to be "cytotoxic" at 100%<br>and 50% extract and "non-<br>cytotoxic" at 25%, 12.5% and<br>6.25% test item extracts to the<br>subconfluent monolayer of L-<br>929 mouse fibroblast cells. | --- | Under the conditions of the<br>study, the undiluted test article<br>extract and 50% test article<br>extract dilution did not meet<br>the requirements of the test<br>and the 25%, 12.5%, 6.25%,<br>and 3.13% test article extract<br>dilutions met the requirements<br>of the test | Same as the<br>Reference<br>Predicate<br>Device | |
| Acute<br>Systemic<br>Toxicity- ISO<br>10993-11:<br>2017 | Under the conditions of this<br>study, there was no evidence of<br>acute systemic toxicity | --- | Under the conditions of the<br>study, there was no mortality<br>or evidence of acute systemic<br>toxicity | Same as the<br>Reference<br>Predicate<br>Device | |
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*Predicate device/reference device perform additional chemotherapy drug test.
*Reference device has been included in the 510K to support substantial equivalence for the subject device with respect to the use of chemotherapy drugs Mitomycin C (0.5 mg/ml) and Methotrexate (25.0 mg/ml) which was not tested in case of the predicate device.
There are no significant differences between the products and are identical in terms of intended use, materials, design and manufacturing methods. The devices meet the ASTM standard D6319 and D6978-05 (2019).
{15}------------------------------------------------
### 5.8 Performance Data: Summary of non-clinical tests conducted for determination of substantial equivalence
The proposed device and its predicate devices share the same intended use, are made of the same material, are within the same minimum specifications of thickness and length by meeting ASTM D6319-19, similar permeation rates for chemotherapy drugs as per ASTM D6978-05, similar labelling, physical properties, freedom from powder, biocompatibility and water tightness.
Permeation rates for additionally claimed chemotherapy drugs Mitomycin C (0.5 mg/ml) and Methotrexate (25.0 mg/ml) which was not tested in case of the predicate device are similar to Reference device as per ASTM D6978-05. It supports substantial equivalence for the subject device with respect to the use of additionally claimed chemotherapy drugs than that of Predicate device.
Biocompatibility studies were performed on the proposed device. Under the conditions of the study, the proposed device is not a sensitizer, or an irritant.
The above test results demonstrated that the proposed device complies with the following standards: ASTM D6319-19
The results of the performance testing demonstrate fulfilment of requirements as per device specific guidance "Medical Glove Guidance Manual" as well as substantial equivalence with predicate. The minor differences in the product does not affect the products safety and efficacy.
| Testing/Standards | Purpose of the Test | Acceptance Criteria | Result |
|-------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| ASTM D-3767<br>Dimensions<br>(Length, Width &<br>thickness) | To determine the<br>length, width and<br>thickness of the<br>gloves | US Glove Supply's Powder<br>Free, Nitrile Examination<br>Gloves (Tested for Use with<br>Chemotherapy Drugs) should<br>meet the requirements of<br>ASTM D6319. | Pass. Powder Free, Nitrile<br>Examination Gloves<br>(Tested for Use with<br>Chemotherapy Drugs)<br>meets the…
