(20 days)
No
The document describes standard nitrile examination gloves and their performance characteristics, with no mention of AI or ML technology.
No
The device, examination gloves, is intended to prevent contamination between patient and examiner, not to treat or cure a disease or condition.
No
These are examination gloves, which are protective barriers for the examiner's hands and are not used for diagnosing medical conditions.
No
The device described is a physical medical device (examination gloves) and does not involve any software component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body (in vitro).
- Device Description and Intended Use: The description clearly states that these are examination gloves worn on the hands to prevent contamination between patient and examiner. They are a barrier device, not a device used to analyze samples from the body.
- Performance Studies and Key Metrics: The performance studies focus on the physical properties of the gloves (dimensions, tensile strength, leakage, powder content, resistance to chemotherapy drugs) and biocompatibility. The key metrics are related to these physical properties and barrier function, not diagnostic test results.
- Lack of Mention of Biological Samples or Analysis: There is no mention of collecting or analyzing biological samples, which is a core characteristic of IVDs.
Therefore, based on the provided information, these nitrile examination gloves are a medical device, but they do not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC, OPJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hands (worn on the examiner's hands)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Examiner / Examination and Medical (Hospitals, Dental Clinics, Chemotherapy Centers, Home-care Centers)
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 tests were conducted for determination of substantial equivalence.
Testing/Standards included:
- ASTM D-3767 Dimensions (Length, Width & thickness): To determine the length, width and thickness of the gloves. Result: Pass. Meets the requirements of ASTM D6319.
- ASTM D-412/D-573 Tensile Strength & Elongation: To determine the Tensile strength and elongation in gloves before aging and after aging. Result: Pass. Meets the requirements of ASTM D6319.
- ASTM D-5151 Leakage/Detection of Holes: Testing for freedom from holes as per ASTM D-5151. Result: Pass. Meets the requirements of ASTM D6319.
- ASTM D6124 Powder Content: To Determine the powder residue using Test Method D6124. Result: Pass. Meets the requirements of ASTM D6319.
- Permeation Testing per ASTM D6978-05 (2019): To determine the Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. Result: Pass. Meets the requirements of ASTM D-6978-05.
Biocompatibility studies included:
- ISO 10993-23 First edition 2021-01 Biological Evaluation of Medical Devices - Part 23, Tests for Irritation. Result: Under the conditions of the study, the test article met the requirements of the test (not an irritant).
- 10993-10 Fourth edition 2021-11 Biological Evaluation of Medical Devices - Part 10, Tests for Skin Sensitization. Result: Under the conditions of the study, the test article was not considered a sensitizer.
- ISO 10993-5 Third edition 2009-06-01 Biological Evaluation of Medical Devices - Part 5, Tests for In Vitro Cytotoxicity. Result: Based on the results obtained under laboratory testing conditions, test item extracts of Nitrile Examination Gloves was found to be "cytotoxic" at 100% and 50% extract and "non-cytotoxic" at 25%, 12.5% and 6.25% test item extracts to the subconfluent monolayer of L-929 mouse fibroblast cells.
- ISO 10993-11 Third edition 2017-09 Biological Evaluation of Medical Devices - Part 11, Tests for Systemic Toxicity. Result: Under the conditions of study, there was no mortality or evidence of acute systemic toxicity.
No clinical testing was required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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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)
| 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.
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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 |
| 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 |
| 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
| 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
| parameters | STANDARDS | (Proposed Device) | (Predicate Device) | (Reference device) | Comparison |
|---|---|---|---|---|---|
| 510(K)Number | -- | K231740 | K172525 | K223559 | Different |
| Manufacturer | |||||
| Name | -- | US Glove Supply | Central Medicare SDN. BHD | Nephron Pharmaceuticals | |
| Corporation | Different | ||||
| Name of device | -- | Powder Free, Nitrile | |||
| Examination Gloves (Tested | |||||
| for Use with Chemotherapy | |||||
| Drugs) | Blue Non-Sterile Powder Free | ||||
| Nitrile Examination Gloves Tested | |||||
| for Use with Chemotherapy Drugs | Nephron Nitrile Powder-Free | ||||
| Nitrile Examination Gloves | |||||
| (Tested for Use with | |||||
| Chemotherapy Drugs) | Different | ||||
| Product Code | -- | LZC, LZA, OPJ | LZA, LZC | LZA, LZC, OPJ | Same with |
| Predicate | |||||
| Device | |||||
| Indication 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. | Blue Non-Sterile Powder Free | ||||
| Nitrile Examination Gloves Tested | |||||
| for Use with Chemotherapy Drugs | |||||
| is a disposable device intended for | |||||
| medical purposes that is worn on | |||||
| the examiner's hand to prevent | |||||
| contamination between patient and | |||||
| examiner. | |||||
| Gloves have been tested for use | |||||
| with chemotherapy drugs using | |||||
| ASTM D6978-05 and will be | |||||
| labelled with a statement of | |||||
| compliance and a summary of the | |||||
| testing results | Nephron Nitrile Powder-Free | ||||
| Nitrile Examination Gloves | |||||
| (Tested for Use with | |||||
| Chemotherapy Drugs) is a | |||||
| disposable device intended for | |||||
| medical purpose that is worn on | |||||
| the examiner's hand to prevent | |||||
| contamination between patient | |||||
| and examiner. In addition, these | |||||
| gloves were tested for use with | |||||
| chemotherapy drugs in | |||||
| accordance with ASTM | |||||
| D6978-05 (2019) Standard | |||||
| Practice for Assessment of | |||||
| Resistance of Medical Gloves | |||||
| to Permeation by | |||||
| Chemotherapy Drugs. | Similar; | ||||
| difference in | |||||
| terminology | |||||
| Regulation | |||||
| 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 | |||
| M 95 | |||||
| L 110 | |||||
| XL 120 | XS 70 | ||||
| S 80 | |||||
| M 95 | |||||
| L 110 | |||||
| XL 120 | M 95 | ||||
| L 113 | |||||
| XL 121 | |||||
| XXL 129 | Same | ||||
| Physical Properties | |||||
| Tensile Strength | ASTM D6319-2019 | Before aging: 14MPa, min | |||
| After aging: 14MPa, min | Before aging: 14MPa, min | ||||
| After aging: 14MPa, min | Same | ||||
| Physical Properties | |||||
| Ultimate Elongation | ASTM D6319-2019 | Before aging: 500%, min | |||
| After aging: 400%, min | Before aging: 500%, min | ||||
| After aging: 400%, min | Same | ||||
| Thickness (mm) | ASTM D6319-19 | Cuff: 0.05 ± 0.02 | |||
| Palm: 0.07 ± 0.02 | |||||
| Finger: 0.09 ± 0.02 | Cuff: 0.06 ± 0.03 | ||||
| Palm: 0.08 ± 0.03 | |||||
| Finger: 0.10 ± 0.03 | Similar; meets ASTM D6319 -19 requirements | ||||
| Powder Free | |||||
| Residue | ASTM | ||||
| D6319-19 | Max 1.38 mg/glove | Max. 0.52 mg per glove |