(96 days)
Powder Free Nitrile Examination Glove 3.5, Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate 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.
These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Powder Free Nitrile Examination Gloves 3.5, Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Medium, Large, Extra Large, Extra Large. Gloves meet the specification of ASTM D6319- 19 and have been tested for resistance to permeation by chemotherapy drugs and Fentanyl Citrate as per ASTMD6978- 05(2019). The gloves are single use, disposable, and provided non-sterile.
The provided text describes the acceptance criteria and performance data for a medical device: "Powder Free Nitrile Examination Glove 3.5, Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate." This is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive study of an AI algorithm. Therefore, many of the requested points related to AI/algorithm performance are not applicable.
Here's the information extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria and reported device performance are primarily based on established ASTM and ISO standards for medical gloves.
| Test | Standard (Acceptance Criteria) | Reported Device Performance (Result) |
|---|---|---|
| Physical Dimensions | ||
| Length | ASTM D6319-19: Minimum 220mm for size XS and S, 230mm for size M, L, XL | Pass |
| Palm Width | ASTM D6319-19: XS: 70±10mm, S: 80±10mm, M: 95±10mm, L:110±10mm, XL: 120±10mm, XXL: 130±10mm | Pass |
| Thickness | ASTM D6319-19: Finger: 0.05mm (min), Palm: 0.05mm (min) | Pass |
| Physical Properties | ||
| Before Aging | ASTM D6319-19, ASTM D412-16 (2021): Tensile strength: 14MPa, min; Ultimate elongation: 500%, min | Pass |
| After Aging | ASTM D6319-19, ASTM D412-16 (2021): Tensile strength: 14MPa, min; Ultimate elongation: 400%, min | Pass |
| Freedom from Holes | ASTM D6319-19, ASTM D5151-19 (Water leak test): G-I, AQL 2.5 (ISO 2859- 1) | Pass |
| Residual Powder | ASTM D6319-19, ASTM D6124-06 (2017): Max 2mg/glove | Pass |
| Biocompatibility | ||
| Skin Sensitization | ISO 10993-10:2021: No Skin sensitization | The sample extract elicits no sensitization reactions under the test conditions. |
| Irritation | ISO 10993-23:2021: No Skin irritation | Under the conditions of this study, the irritation response category of the test article is classified as Negligible for polar extract and Negligible for non-polar extract. |
| Acute Systemic Toxicity | ISO 10993-11:2017: Subject showed no adverse biological reaction | No death or acute systemic toxicity was observed in the mice which received injection of extract. |
| Chemotherapy Drugs Permeation (ASTM D6978-05 (2019)) | Minimum Breakthrough Detection Time (Minutes) | Minimum Breakthrough Detection Time (Minutes) |
| Carmustine (BCNU) (3.3mg/ml) | Refer to table for specific times (N/A – no general acceptance criteria provided, specific data shown) | 1.3 (Note: "Warning: Do not use with Carmustine and Thiotepa" due to extremely low permeation times) |
| Cisplatin (1mg/ml) | >240 | >240 |
| Cyclophosphamide (20mg/ml) | >240 | >240 |
| Dacarbazine (10.0 mg/ml) | >240 | >240 |
| Doxorubicin HCl (2 mg/ml) | >240 | >240 |
| Etoposide (20mg/ml) | >240 | >240 |
| Fluorouracil (50mg/ml) | >240 | >240 |
| Paclitaxel (6mg/ml) | >240 | >240 |
| Thiotepa (10mg/ml) | Refer to table for specific times (N/A – no general acceptance criteria provided, specific data shown) | 1.1 (Note: "Warning: Do not use with Carmustine and Thiotepa" due to extremely low permeation times) |
| Fentanyl Citrate Permeation (ASTM D6978-05 (2019)) | Minimum Breakthrough Detection Time (Minutes) | Minimum Breakthrough Detection Time (Minutes) |
| Fentanyl Citrate Injection, 100mcg/2ml | >240 | >240 |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for each individual test (e.g., number of gloves for physical dimensions, number of test replicates for permeation). However, the standard ASTM D6319-19 for physical dimensions and freedom from holes, and ASTM D6978-05 for permeation, typically define the sampling plans.
The data provenance is from "Yue Kang Anhui Medical Products Co., Ltd" in China. The studies are non-clinical performance tests, conducted to verify the device meets design specifications and relevant standards. They are retrospective in the sense that they are tests performed on manufactured products, not prospective clinical trials.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This document is for a medical glove, and the "ground truth" for the test set is established by the specifications of industrial standards (ASTM, ISO) and laboratory testing methodologies, not by expert medical review or consensus on images/data.
4. Adjudication Method for the Test Set
Not applicable. As described above, the compliance is determined by adherence to standardized test methods and their defined acceptance criteria. There is no human adjudication process involved in these performance tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
Not applicable. This is a submission for a physical medical device (glove) and does not involve an AI algorithm or human-in-the-loop performance evaluation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This submission is for a medical glove, not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" here is defined by the technical specifications and performance requirements outlined in the referenced industry standards (ASTM D6319-19, ASTM D5151-19, ASTM D6124-06, ASTM D412-16, ASTM D6978-05, ISO 10993-10, ISO 10993-23, ISO 10993-11). These standards represent established, objective, and reproducible test methods for evaluating medical glove performance and biocompatibility.
8. The Sample Size for the Training Set
Not applicable. This is a physical device, not an AI model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this type of device.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows 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.
April 8, 2024
Yue Kang Anhui Medical Products Co., Ltd Amy Gao Ouality Engineer No 375, Yunjin Road Huaibei. Anhui 235000 China
Re: K240021
Trade/Device Name: Powder Free Nitrile Examination Glove 3.5, Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZA, LZC, QDO, OPJ Dated: March 8, 2024 Received: March 8, 2024
Dear Amy Gao:
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 (QS) 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.
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 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).
{2}------------------------------------------------
Sincerely,
Bifeng Qian -S
Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery 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) K240021
Device Name
Powder Free Nittile Examination Glove 3.5, Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Indications for Use (Describe)
Powder Free Nitrile Examination Glove 3.5, Blue Color. Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentany] Citrate 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.
These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Test Chemotherapy drug are as followings:
| Test Chemotherapy drug & Concentration | Minimum Breakthrough Detection Time (Minutes) |
|---|---|
| Carmustine (BCNU) (3.3mg/ml) | 1.3 |
| Cisplatin (1mg/ml) | >240 |
| Cyclophosphamide (20mg/ml) | >240 |
| Dacarbazine (10.0 mg/ml) | >240 |
| Doxorubicin HCl (2 mg/ml) | >240 |
| Etoposide (20mg/ml) | >240 |
| Fluorouracil (50mg/ml) | >240 |
| Paclitaxel (6mg/ml) | >240 |
| Thiotepa (10mg/ml) | 1.1 |
Test Fentanyl Citrate are as follows: Fentanyl Citrate Injection 100mcg/2ml
Warning: Do not use with Carmustine and Thiotepa.
Please note that the following drugs have extremely low permeation times: Carmustine (BCNU): 1.3 minutes and Thiotepa:1.1 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.
240
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 (K240021)
Date Prepared: April 3, 2024
1. Owner's Identification:
Applicant Name: Yue Kang Anhui Medical Products Co., Ltd Location: No 375, Yunjin Road, Huaibei City, Anhui, China Contact Person: Amy Gao Tel: +86-18266365220
2. Name of the Device:
Trade / Product Name: Powder Free Nitrile Examination Glove 3.5, Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Common Name: Exam Gloves Classification Name: Non-Powdered Patient Examination Glove Specialty Regulation: 21 CFR 880.6250 Product Code: LZA, LZC, QDO, OPJ Classification Panel: General Hospital Device Class: Class I
3. Predicate Device Information:
Professional Latex Sdn Bhd Powder Free Nitrile Examination Glove, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K220088) Product code LZA, LZC, QDO, OPJ.
4. Device Descrintion:
Powder Free Nitrile Examination Gloves 3.5, Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Medium, Large, Extra Large, Extra Large. Gloves meet the specification of ASTM D6319- 19 and have been tested for resistance to permeation by chemotherapy drugs and Fentanyl Citrate as per ASTMD6978- 05(2019). The gloves are single use, disposable, and provided non-sterile.
5. Indications for Use:
Powder Free Nitrile Examination Glove 3.5, Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate 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.
These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
{5}------------------------------------------------
| Test Chemotherapy drug & Concentration | Minimum Breakthrough Detection Time (Minutes) |
|---|---|
| Carmustine (BCNU) (3.3mg/ml) | 1.3 |
| Cisplatin (1mg/ml) | >240 |
| Cyclophosphamide (20mg/ml) | >240 |
| Dacarbazine (10.0 mg/ml) | >240 |
| Doxorubicin HCl (2 mg/ml) | >240 |
| Etoposide (20mg/ml) | >240 |
| Fluorouracil (50mg/ml) | >240 |
| Paclitaxel (6mg/ml) | >240 |
| Thiotepa (10mg/ml) | 1.1 |
| Test Fentanyl Citrate are as follows: | Minimum Breakthrough Detection Time in minutes |
|---|---|
| --------------------------------------- | ------------------------------------------------ |
Fentanyl Citrate Injection 100mcg/2ml
Warning: Do not use with Carmustine and Thiotepa. Please note that the following drugs have extremely low permeation times: Carmustine (BCNU): 1.3 minutes and Thiotepa:1.1 minutes.
240
6. Comnarison of Subiect Device and Predicate Device:
The following tables are summaries of the technological characteristics, biocompatibility and
testing for use with chemotherapy drugs & Fentanyl Citrate of the proposed and predicate devices.
General Comparison Table:
| Device | Proposed Device | Predicate Device | Comparison |
|---|---|---|---|
| 510K # | K240021 | K220088 | N/A |
| Product Name | Powder Free Nitrile ExaminationGlove 3.5, Blue Color, Non-Sterile,and Tested for Use withChemotherapy Drugs and FentanylCitrate | Powder Free Nitrile ExaminationGlove, Non-Sterile, and Tested forUse with Chemotherapy Drugs andFentanyl Citrate | Different |
| Product Code | LZA, LZC, QDO, OPJ | LZA, LZC, QDO, OPJ | Same |
| RegulationNumber | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Indications foruse | Powder Free Nitrile ExaminationGlove 3.5, Blue Color, Non-Sterile,and Tested for Use withChemotherapy Drugs and FentanylCitrate is a disposable deviceintended for medical purposes thatis worn on the examiner's hand orfinger to prevent contaminationbetween patient and examiner.These gloves were tested for usewith Chemotherapy Drugs andFentanyl Citrate as per ASTMD6978-05 (Reapproved 2019) | Powder free Nitrile ExaminationGloves, Non-Sterile and tested foruse with Chemotherapy Drugs andFentanyl Citrate is a patient medicalexam gloves which is a disposal deviceintended for medical purposes that isworn on the examiners' hand orfinger to prevent contaminationbetween examiner and patient.The glove was tested for use withChemotherapy Drugs and FentanylCitrate as per ASTM D6978-05 | Same |
{6}------------------------------------------------
| Standard Practice for Assessment ofMedical Gloves to Permeation byChemotherapy Drugs. | Standard Practice for Assessment ofMedical Gloves to permeation bychemotherapy Drugs | ||
|---|---|---|---|
| Powder free | Yes | Yes | Same |
| Design feature | Ambidextrous | Ambidextrous | Same |
| Material | Nitrile | Nitrile | Same |
| Color | Blue | Blue | Different |
| Size | XS, S, M, L, XL, XXL | XS, S, M, L, XL | Different |
| Sterile | Non-Sterile | Non-Sterile | Same |
| Use | Single use | Single use | Same |
| Chemotherapy Drugs and Fentanyl Citrate Claim | See below comparison table | See below comparison table | Same |
Analysis: The proposed device has size XS, S, M, L, XL, XXL, while the predicate device has size XS, S, M, L, XL. But performance testing has been done to the proposed device and the results showed that the device meets the requirements of standard ASTM D6319-19. Therefore, this difference does not raise any new safety or performance questions.
Technological Characteristic and Biocompatibility Comparison Table:
| Item | Standard | Proposed device | Predicate device K220088 | Result |
|---|---|---|---|---|
| Dimension | ASTM D6319-19 | Length: Min 230mmWidth(mm):XS: 70±10S: 80±10M: 95±10L: 110±10 XL:120±10 XXL:130±10Thickness(mm):Palm: Minimum 0.05Finger: Minimum 0.05 | Length: Min 240mmWidth(mm):XS: 70±10S: 80±10M: 95±10L: 110±10 XL120±10 XXL:Thickness:(mm)Palm: Minimum 0.05Finger: Minimum 0.05 | Similar |
| Physical propertiesBefore agingTensile strengthUltimate elongationAfter agingTensile strengthUltimate elongation | ASTM D6319-19ASTM D412-16 | 14MPa, min500%, min14MPa, min400%, min | 14MPa, min500%, min14MPa, min400%, min | Same |
| Freedom from holes | ASTM D6319-19ASTM D5151-19 | G-I, AQL2.5 | G-I, AQL2.5 | Same |
{7}------------------------------------------------
| Residual Powder | ASTM D6319-19ASTM D6124-06 | ≤ 2 mg per glove | ≤ 2 mg per glove | Same |
|---|---|---|---|---|
| Biocompatibility | IrritationISO 10993-23 | Under the conditions of thisstudy, the irritation responsecategory of the test article isclassified as Negligible forpolar extract and Negligiblefor non-polar extract. | Under the conditions of thestudy, the subject device isnon- irritating | Similar① |
| SensitizationISO 10993-10 | The sample extract elicits nosensitization reactions underthe test conditions | Under the condition of thestudy, the subject device isnon-sensitizer | Similar | |
| Acute SystemicToxicity TestISO 10993 -11 | No death or acute systemictoxicity was observed in themice which receivedinjection of the extract | Under the conditions of thestudy, the subject showed noadverse biological reaction | Similar |
() The new version of standard for Skin Irritation we refer is ISO 10993-23:2021, the test method and process is the same as the old version ISO 10993-10
Chemotherapy drug Permeation and Fentanyl Citrate Comparison Claim:
| Chemotherapy Drug | Minimum Breakthrough DetectionTime (Minutes) | Remark | |
|---|---|---|---|
| Proposed device | Predicate deviceK220088 | ||
| Carmustine (BCNU) (3.3mg/ml) | 1.3 | 24.3 | Different |
| Cisplatin (1mg/ml) | >240 | >240 | Same |
| Cyclophosphamide (20mg/ml) | >240. | >240 | Same |
| Dacarbazine (10.0 mg/ml) | >240 | >240 | Same |
| Doxorubicin HCl (2 mg/ml) | >240 | >240 | Same |
| Etoposide (20mg/ml) | >240 | >240 | Same |
| Fluorouracil (50mg/ml) | >240 | >240 | Same |
| Paclitaxel (6mg/ml) | >240 | >240 | Same |
| Thiotepa (10mg/ml) | 1.1 | 48.6 | Different |
| Ifosfamide (50.0 mg/ml) | / | >240 | Different |
| Mitoxantrone (2.0 mg/ml) | / | >240 | Different |
| Vincristine Sulfate (1.0 mg/ml) | / | >240 | Different |
- Chemotherapy drugs and the minimum breakthrough time of subject device will be listed on labeling, so this different does not raise questions of safety and effectiveness.
| Minimum Breakthrough Detection Time (Minutes) | |||
|---|---|---|---|
| Fentanyl Citrate | Proposed device | Predicate deviceK220088 | Remark |
| Fentanyl Citrate Injection, 100mcg/2mL | >240 | >240 | Same |
Summary of Non-Clinical Performance Data
Non-clinical tests were conducted to verify that the proposed device met all design specifications.
The test results demonstrated that the proposed device met the performance criteria with the following standards:
{8}------------------------------------------------
| Methodology | Test Performed | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM D6319- 19 | Physical DimensionsLength | Minimum 220mm for size XSand S, 230mm for size M, L, XL | Pass |
| ASTM D6319- 19 | Physical Dimensions PalmWidth | XS: 70±10mmS: 80±10mmM: 95±10mmL:110±10mm XL:120±10mmXXL: 130±10mm | Pass |
| ASTM D6319- 19 | Physical DimensionsThickness | Finger: 0.05mm (min)Palm: 0.05mm (min) | Pass |
| ASTM D6319- 19ASTM D412-16 (2021) | Physical Properties | Before aging: 14MPa, min500%, minAfter aging: 14MPa, min400%, min | Pass |
| ASTM D6319- 19ASTM D5151-19 | Water leak test | G-I, AQL 2.5 (ISO 2859- 1) | Pass |
| ASTM D6319- 19ASTM D6124-06 (2017) | Powder Residue | Max 2mg/glove | Pass |
| ASTM D6978-05 (2019) | Permeation byChemotherapy Drugs | Refer the above table 1 | Pass |
| ISO 10993-10:2021 | Skin Sensitization | No Skin sensitization | The sample extractelicits no sensitizationreactions under thetest conditions |
| ISO 10993-23:2021 | Irritation | No Skin irritation | Under the conditions ofthis study, the irritationresponse category of thetest article is classifiedas Negligible for polarextract and Negligiblefor non-polar extract. |
| ISO 10993-11:2017 | Acute systemic toxicitystudy | Subject showed no adversebiological reaction | No death or acutesystemic toxicity wasobserved in the micewhich received injectionof extract |
{9}------------------------------------------------
- ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.
- ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves. .
- ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves .
ASTM D412-16 (2021) Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers-Tension
ASTM D6978-05 (Reapproved 2019), Assessment of Reissuance of Medical Gloves to Permeation by Chemotherapy Drugs.
- ISO 10993-10: 2021 Biological evaluation of medical devices Part 10: Tests for skin sensitization.
- ISO10993-23:2021 Biological evaluation of medical devices Part 23: Tests for irritation.
- ISO 10993-11:2017 Biological evaluation of medical devices Part 11: Tests for systemic toxicity .
7. Summary of Clinical Testing:
Not provided for the subject device.
8. Conclusion:
The conclusions drawn from the non-clinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device, K.220088, Powder Free Nitrile Examination Glove, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate.
§ 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.