(24 days)
NITRILE EXAMINATION GLOVES (Tested For Use With Chemotherapy Drugs) is a non-sterile disposable device intended for medical purposes that is worn on the exammer's hands or finger to prevent contamination between patient and examiner. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05(2023) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes, and can be used with the device.
Cyclophosphamide (20.0 mg/ml) Doxorubicin HCl (2.0 mg/ml) Etoposide (20.0 mg/ml) Fluorouracil (50.0 mg/ml) Paclitaxel (6.0 mg/ml) Cisplatin (1.0 mg/ml) Dacarbazine (10.0 mg/ml)
The following chemotherapy drugs have low permeation times: Carmustine (3.3 mg/ml): 15 minutes ThioTEPA (10.0 mg/ml): 97 minutes
Warning: Not for Use with: Carmustine, ThioTEPA
NITRILE EXAMINATION GLOVES (Tested For Use With Chemotherapy Drugs) is a Class I, patient examination gloves bearing the product codes LZA, LZC, OPJ (21CFR880.6250). They meet all the current specifications listed under the ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application and also complies with requirements for Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs as per D6978-05(2023). They are made from Nitrile (NBR). These gloves are blue in color and are powder free. The product is non-sterile, ambidextrous and single use only. NITRILE EXAMINATION GLOVES (Tested For Use With Chemotherapy Drugs) are offered in different sizes: S/M/L/XL.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Performance |
|---|---|---|---|
| Physical Dimensions | |||
| Length (S) | Physical Dimensions Test | $\ge$ 220 mm | $\ge$ 220 mm |
| Length (M/L/XL) | Physical Dimensions Test | $\ge$ 230 mm | $\ge$ 230 mm |
| Width (S) | Physical Dimensions Test | 80 $\pm$ 10 mm | 84-86/Pass |
| Width (M) | Physical Dimensions Test | 95 $\pm$ 10 mm | 96-102/Pass |
| Width (L) | Physical Dimensions Test | 110 $\pm$ 10 mm | 104-107/Pass |
| Width (XL) | Physical Dimensions Test | 120 $\pm$ 10 mm | 114-116/Pass |
| Thickness (Palm) | Physical Dimensions Test | $\ge$ 0.05 mm | 0.07-0.08/Pass |
| Thickness (Finger) | Physical Dimensions Test | $\ge$ 0.05 mm | 0.09-0.11/Pass |
| Watertightness | Detection of Holes | AQL 2.5 | 0/125/Pass |
| Powder Content | Powder Content | $\le$ 2.0 mg per glove | 0.16-0.19 mg/Pass |
| Physical Properties | |||
| Tensile Strength (before aging) | Physical Properties | $\ge$ 14 Mpa | 20-24 Mpa |
| Tensile Strength (after aging) | Physical Properties | $\ge$ 14 Mpa | 15-23 Mpa |
| Ultimate Elongation (before aging) | Physical Properties | $\ge$ 500 % | 501-598 % |
| Ultimate Elongation (after aging) | Physical Properties | $\ge$ 400 % | 471-561 % |
| Chemotherapy Permeation | Chemotherapy drug claim | No breakthrough up to 240 minutes for specified drugs | >240 minutes for Cyclophosphamide, Doxorubicin HCl, Etoposide, Fluorouracil, Paclitaxel, Cisplatin, Dacarbazine |
| Low permeation times for specified drugs | Carmustine: 15 minutes, ThioTEPA: 97 minutes | ||
| Cytotoxicity | Cytotoxicity | Non-cytotoxic | Device extract is cytotoxic (met acceptance criteria by identifying the result) |
| Irritation | Irritation | Non-irritating | Non-irritant / Pass |
| Sensitization | Sensitization | Non-sensitizing | Non-sensitizer / Pass |
| Acute Systemic Toxicity | Acute Systemic Toxicity | Non-acute systemic toxicity | Did not show acute systemic toxicity in vivo. / Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for each individual test or the data provenance (e.g., country of origin, retrospective/prospective). However, for the watertightness test (ASTM D5151/ASTM D6319), it reports "0/125/Pass" which indicates a sample size of 125 gloves were tested for holes, and none failed.
The non-clinical tests were conducted to verify that the proposed device met all design specifications according to recognized standards. The identity of the testing laboratories or the origin of the samples is not specified in this document.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This document describes non-clinical performance testing of a physical device (gloves). Therefore, there is no "ground truth" derived from expert interpretation of medical images or data in the typical sense. The ground truth for these tests is established by the specified standards (ASTM and ISO standards) themselves, which outline quantitative metrics and methodologies for evaluation. No human experts are explicitly mentioned as establishing ground truth for these specific tests.
4. Adjudication Method for the Test Set
Not applicable. The tests performed are objective, quantitative measurements against established standards, not subjective assessments requiring adjudication or consensus among experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC comparative effectiveness study is not applicable to the non-clinical performance testing of medical gloves. This type of study is typically used for evaluating the effectiveness of diagnostic or prognostic medical devices that rely on human interpretation, often with AI assistance, in comparison to human interpretation alone.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This document pertains to the physical performance of medical gloves, not a software algorithm that would operate in a standalone mode.
7. Type of Ground Truth Used
The ground truth for all tests is based on established testing standards and their quantitative acceptance criteria. For example:
- Physical dimensions are compared against numerical ranges specified in ASTM D6319-19.
- Watertightness is assessed by the absence of holes per ASTM D5151-19, with an acceptable quality level (AQL).
- Powder content is measured against a maximum limit per ASTM D6124-06.
- Tensile strength and ultimate elongation are measured against minimum requirements per ASTM D6319-19.
- Chemotherapy drug permeation is determined by breakthrough detection times as per ASTM D6978-05(2023).
- Biocompatibility tests (cytotoxicity, irritation, sensitization, acute systemic toxicity) are evaluated according to ISO 10993 series standards.
8. Sample Size for the Training Set
Not applicable. This document is about a physical medical device (gloves) and its non-clinical performance testing, not an AI/ML-based device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
{0}------------------------------------------------
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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 12, 2024
Nb Medical Company Limited % Wendy Huang Technical Manager Wenzhou ThiWe Business Consulting Co., Ltd. Room 1203, Building C, Hua'ou Jiayuan, No.50 Tangjiaqiao South Road, Longwan District Wenzhou, Zhejiang 325000 China
Re: K242812
Trade/Device Name: NITRILE EXAMINATION GLOVES (Tested For Use With Chemotherapy Drugs) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, OPJ Dated: August 12, 2024 Received: September 18, 2024
Dear Wendy Huang:
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,
Bifeng Qian -S
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) K242812
Device Name NITRILE EXAMINATION GLOVES (Tested For Use With Chemotherapy Drugs)
Indications for Use (Describe)
NITRILE EXAMINATION GLOVES (Tested For Use With Chemotherapy Drugs) is a non-sterile disposable device intended for medical purposes that is worn on the exammer's hands or finger to prevent contamination between patient and examiner. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05(2023) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes, and can be used with the device.
Cyclophosphamide (20.0 mg/ml) Doxorubicin HCl (2.0 mg/ml) Etoposide (20.0 mg/ml) Fluorouracil (50.0 mg/ml) Paclitaxel (6.0 mg/ml) Cisplatin (1.0 mg/ml) Dacarbazine (10.0 mg/ml)
The following chemotherapy drugs have low permeation times: Carmustine (3.3 mg/ml): 15 minutes ThioTEPA (10.0 mg/ml): 97 minutes
Warning: Not for Use with: Carmustine, ThioTEPA
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}------------------------------------------------
510(k) Summary
K242812
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter Information
| · Company Name: | NB MEDICAL COMPANY LIMITED |
|---|---|
| · Address: | Tay An Industrial Cluster, Tien Hai Town, Tien Hai District,Thai Binh Province, Vietnam |
| · Phone Number: | +84-934-388877 |
| · Contact: | VU THI VINH |
2.0 Designated Submission Correspondent
| · Company Name: | Wenzhou ThiWe Business Consulting Co., Ltd. | |
|---|---|---|
| · Address: | Room 1203, Building C, Hua'ou Jiayuan, No.50 TangjiaqiaoSouth Road, Longwan District, Wenzhou, Zhejiang, 325000,CHINA | |
| · Phone Number: | 86-577-88201260 | |
| · Contact: | Ms. Wendy Huang | |
| · Email: | thiwe_reg@outlook.com |
3.0 Date of Preparation: October 3, 2024
4.0 Device Information
・Trade/Device Name: NITRILE EXAMINATION GLOVES (Tested For Use With Chemotherapy Drugs)
・Model(s): S, M, L, XL (Blue)
・ Common Name: Patient Examination Gloves (Tested For Use With Chemotherapy Drugs)
・510(k) Number: K242812
{5}------------------------------------------------
5.0 Classification
- · Device: Polymer Patient Examination Glove & Medical Glove, Specialty & Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
- · Regulation Description: Non-powdered patient examination glove.
- · Review Panel: General Hospital
- · Product Code: LZA, LZC, OPJ
- · Submission Type: 510(k)
- · Regulation Number: 21 CFR 880.6250
- · Device Class: 1
6.0 Predicate Device Information
- · Device Name: NITRILE EXAMINATION GLOVES
- ・510(k) Number: K220343
- · Manufacturer: NB Medical Co., LTD (i.e. NB MEDICAL COMPANY LIMITED)
7.0 Device Description
NITRILE EXAMINATION GLOVES (Tested For Use With Chemotherapy Drugs) is a Class I, patient examination gloves bearing the product codes LZA, LZC, OPJ (21CFR880.6250). They meet all the current specifications listed under the ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application and also complies with requirements for Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs as per D6978-05(2023). They are made from Nitrile (NBR). These gloves are blue in color and are powder free. The product is non-sterile, ambidextrous and single use only. NITRILE EXAMINATION GLOVES (Tested For Use With Chemotherapy Drugs) are offered in different sizes: S/M/L/XL.
{6}------------------------------------------------
8.0 Indications for Use
NITRILE EXAMINATION GLOVES (Tested For Use With Chemotherapy Drugs) is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05(2023) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes, and can be used with the device.
Cyclophosphamide (20.0 mg/ml) Doxorubicin HCl (2.0 mg/ml) Etoposide (20.0 mg/ml) Fluorouracil (50.0 mg/ml) Paclitaxel (6.0 mg/ml) Cisplatin (1.0 mg/ml) Dacarbazine (10.0 mg/ml)
The following chemotherapy drugs have low permeation times: Carmustine (3.3 mg/ml): 15 minutes ThioTEPA (10.0 mg/ml): 97 minutes
Warning: Not for Use with: Carmustine, ThioTEPA
9.0 Comparison of Intended Use and Technological Characteristics with the Predicate Device
The table below compares the intended use and technological characteristics of the subject and predicate device.
Table 1: Comparison Table for Subject and Predicate Device
{7}------------------------------------------------
| Item | Subject Device(K242812) | Predicate Device(K220343) | Comparison |
|---|---|---|---|
| General Comparison | |||
| Product Code | LZA, LZC, OPJ | LZA | DifferentAnalysis 1 |
| Regulation No. | 21 CFR880.6250 | 21 CFR880.6250 | Same |
| Class | 1 | 1 | Same |
| IntendedUse/Indications forUse | NITRILEEXAMINATIONGLOVES (Tested ForUse WithChemotherapy Drugs)is a non-steriledisposable deviceintended for medicalpurposes that is wornon the examiner'shands or finger toprevent contaminationbetween patient andexaminer. These gloveswere tested for use withChemotherapy Drugsas per ASTMD6978-05(2023)Standard Practice forAssessment of MedicalGloves to Permeationby Chemotherapy | NITRILEEXAMINATIONGLOVES is anon-sterile disposabledevice intended formedical purposes that isworn on the examiner'shands or finger toprevent contaminationbetween patient andexaminer. | DifferentAnalysis 1 |
| Drugs. | |||
| Material | Nitrile | Nitrile | Same |
| Powder Free | Yes | Yes | Same |
| Design Feature | Ambidextrous | Ambidextrous | Same |
| Color | Blue | White/CobaltBlue/Black/Blue | DifferentAnalysis 2 |
| Size | S/M/L/XL | S/M/L/XL | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Use | Single Use | Single Use | Same |
| Rx Only or OTC | OTC | OTC | Same |
| ChemotherapyDrugs Claim | The followingchemotherapy drugsand concentration hadNO breakthroughdetected up to 240minutes, and can beused with the device.Cyclophosphamide(20.0 mg/ml)Doxorubicin HCl (2.0mg/ml)Etoposide (20.0 mg/ml)Fluorouracil (50.0mg/ml)Paclitaxel (6.0 mg/ml)Cisplatin (1.0 mg/ml)Dacarbazine (10.0mg/ml) | No chemotherapy drugsclaim | DifferentAnalysis 1 |
| The followingchemotherapy drugshave low permeationtimes:Carmustine (3.3 mg/ml): 15 minutesThioTEPA (10.0 mg/ml): 97 minutesWarning: Not for Use with: Carmustine, ThioTEPA | |||
| LabelingInformation | Single-use indication,powder free, device color, device name,glove size and quantity,Non-Sterile, applicablechemotherapy drugsand the minimumbreakthrough time | Single-use indication,powder free, devicecolor, device name,glove size and quantity,Non-SterileDifferentAnalysis 1 | |
| Technological Characteristic and Biocompatibility Comparison | |||
| Dimensions -Length | S: ≥220mmM/L/XL: ≥230mmMeet the requirementof ASTM D6319-19 | S: ≥220mmM/L/XL: ≥230mmMeet the requirementof ASTM D6319-19Same | |
| Dimensions -Width | S: 80±10 mmM: 95±10 mmL: 110±10 mm | S: 80±10 mmM: 95±10 mmL: 110±10 mmSame | |
| Meet the requirementof ASTM D6319-19 | Meet the requirementof ASTM D6319-19 | ||
| PhysicalProperties -Tensile Strength | before aging ≥14 Mpaafter aging ≥14 Mpa | before aging ≥14 Mpaafter aging ≥14 Mpa | Same |
| Meet the requirementof ASTM D6319-19 | Meet the requirementof ASTM D6319-19 | ||
| PhysicalProperties -UltimateElongation | before aging ≥500 %after aging ≥400 % | before aging ≥500 %after aging ≥400 % | Same |
| Meet the requirementof ASTM D6319-19 | Meet the requirementof ASTM D6319-19 | ||
| Thickness | Palm: ≥0.05 mmFinger: ≥0.05 mm | Palm: ≥0.05 mmFinger: ≥0.05 mm | Same |
| Meet the requirementof ASTM D6319-19 | Meet the requirementof ASTM D6319-19 | ||
| Powder FreeResidue | ≤2.0mg per glove | ≤2.0mg per glove | Same |
| Meet the requirementof ASTM D 6124following ASTMD6319-19 | Meet the requirementof ASTM D 6124following ASTMD6319-19 | ||
| Freedom fromholes | Be free from holeswhen tested inaccordance with ASTMD5151 followingASTM D6319-19AQL=2.5 | Be free from holeswhen tested inaccordance with ASTMD5151 followingASTM D6319-19AQL=2.5 | Same |
| Biocompatibility | ISO 10993-5Under conditions of thestudy, device extract iscytotoxic | ISO 10993-5Under conditions of thestudy, device extract iscytotoxic | Same |
| ISO 10993-10 | ISO 10993-10 | Same | |
| Under the conditions ofthe study, not an irritantor a sensitizer | Under the conditions ofthe study, not an irritantor a sensitizer | ||
| ISO 10993-11 | ISO 10993-11 | Same | |
| Under the condition ofacute systemic toxicitytest, the test article didnot show acutesystemic toxicity invivo. | Under the condition ofacute systemic toxicitytest, the test article didnot show acutesystemic toxicity invivo. |
{8}------------------------------------------------
{9}------------------------------------------------
{10}------------------------------------------------
{11}------------------------------------------------
Analysis 1: The subject device has different indications for use to the predicate device, which results in different product codes, that is, the subject device has extra applicable product codes compared with the predicate device. The major difference between the two devices is that the subject device is claimed for use with certain chemotherapy drugs, while the predicate device did not. However, such difference has been tested according to FDA recognized standard - ASTM D6978-05(2023) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs, which ensures that the subject device will be as safe as for use as the predicate device. Meanwhile, chemotherapy drugs and the minimum breakthrough time of subject device will be listed on labeling, so this different will not bring new concerns regarding safety and effectiveness.
Analysis 2: The subject device is offered only in a single color (Blue) whereas the predicate is offered in different colors (White/Cobalt Blue/Black/Blue), but the color of the subject device is included by those of the predicate device, so such difference will not bring questions regarding safety and effectiveness.
{12}------------------------------------------------
10.0 Summary of Non-Clinical Performance Testing
Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:
ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves
ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves.
ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.
ASTM D6978-05(2023) Standard Practice for Assessment of Medical Gloves to
Permeation by Chemotherapy Drugs.
ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
ISO 10993-11:2017, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity.
| Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM D6319 | PhysicalDimensions Test | Length:S: $\geq$ 220mm | Length:S: $\geq$ 220mm |
| M/L/XL: $\geq$ 230mm | M/L/XL: $\geq$ 230mm | ||
| Width:S: 80 $\pm$ 10 mmM: 95 $\pm$ 10 mmL: 110 $\pm$ 10 mmXL: 120 $\pm$ 10 mm | Width:S: 84-86/PassM: 96-102/PassL: 104-107/PassXL: 114-116/Pass | ||
| Thickness: | Thickness: |
Table 2: Summary of non-clinical performance testing
{13}------------------------------------------------
| Palm: ≥0.05 mmFinger: ≥0.05 mm | Finger:0.09-0.11/PassPalm:0.07-0.08/Pass | ||
|---|---|---|---|
| ASTM D5151ASTM D6319 | WatertightnessTest forDetection ofHoles | Meet the requirementsof ASTM D5151 AQL2.5 | 0/125/Pass |
| ASTM D6124ASTM D6319 | Powder Content | Meet the requirementof ASTM D 6124≤2.0mg | 0.16-0.19mg/Pass |
| ASTM D412ASTM D6319 | PhysicalProperties | Tensile Strength:before aging ≥14 Mpaafter aging ≥14 MpaUltimate Elongation:before aging ≥500 %after aging ≥400 % | Tensile Strength:before aging:20-24Mpaafter aging:15-23MpaUltimateElongation:before aging:501-598%after aging:471-561% |
| ASTM D6978 | Chemotherapydrug claim | The chemotherapydrugs andconcentration whichhave NO breakthroughdetected up to 240 | The followingchemotherapydrugs andconcentration hadNO breakthrough |
| minutes can besuggested for use withthe subject device. | detected up to 240minutes, and can beused with thedevice.Cyclophosphamide(20.0 mg/ml)Doxorubicin HCl(2.0 mg/ml)Etoposide (20.0mg/ml)Fluorouracil (50.0mg/ml)Paclitaxel (6.0mg/ml)Cisplatin (1.0mg/ml)Dacarbazine (10.0mg/ml)The followingchemotherapydrugs have lowpermeation times:Carmustine (3.3mg/ml): 15 minutesThioTEPA (10.0mg/ml): 97 minutesWarning: Not for | ||
| Use with: | |||
| Carmustine, | |||
| ThioTEPA | |||
| ISO 10993-5 | Cytotoxicity | toxicity | Under conditionsof the study, deviceextract is cytotoxic. |
| ISO 10993-10 | Irritation | Non-irritating | Under theconditions of thestudy, not anirritant. / Pass |
| ISO 10993-10 | Sensitization | Non-sensitizing | Under theconditions of thestudy, not ansensitizer. / Pass |
| ISO 10993-11 | Acute SystemicToxicity | Non-acute systemic | Under theconditions of thestudy, did not showacute systemictoxicity in vivo. /Pass |
{14}------------------------------------------------
{15}------------------------------------------------
Table 3 Chemotherapy Permeation Testing Claim
| Chemotherapy Drug | Minimum Breakthrough Detection Time(Minutes) |
|---|---|
| Cyclophosphamide (20.0 mg/ml) | >240 |
| Doxorubicin HCl (2.0 mg/ml) | >240 |
| Etoposide (20.0 mg/ml) | >240 |
| Fluorouracil (50.0 mg/ml) | >240 |
| Paclitaxel (6.0 mg/ml) | >240 |
| Cisplatin (1.0 mg/ml) | >240 |
{16}------------------------------------------------
| Dacarbazine (10.0 mg/ml) | >240 |
|---|---|
| Carmustine (3.3 mg/ml) | 15 |
| ThioTEPA (10.0 mg/ml) | 97 |
11.0 Summary of Clinical Testing
Clinical testing is not needed for this device.
12.0 Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject device NITRILE EXAMINATION GLOVES (Tested For Use With Chemotherapy Drugs) is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K220343.
§ 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.