(168 days)
The nitrile examination glove is intended to be worn on the examiner's hand to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.
These gloves were tested for use with chemotherapy drugs per ASTM D6978-05 (2019)Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Tested chemotherapy drugs are as follows: Carboplatin, 10 mg/ml >240 min. Carmustine (BCNU), 3.3 mg/ml 27.5 min Cisplatin, 1.0 mg/ml >240 min Cyclophosphamide (Cytoxan), 20.0 mg/ml >240 min Doxorubicin HCI, 2.0 mg/ml >240 min Etoposide, 20.0 mg/ml >240 min Fluorouracil, 50.0 mg/ml >240 min Paclitaxel, 6.0 mg/ml >240 min Thio Tepa, 10.0 mg/ml 88.2 min
Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 27.5 Minutes, Thio Tepa 10.0 mg/ml 88.2 Minutes.
Warning: Please do not use with Carmustine and Thio Tepa.
The proposed device (Mode: NG101) is powder free nitrile examination gloves, provided as non-sterile and disposable device. The proposed devices are blue color and there are five sizes, include XS (6.5"), S (7"), M (8"), L (8.5"), XL (9") for optional. The examination glove is smooth surface with textured fingertips and a rolled rim at the cuff edge. This is a single-use, powder-free, non-sterile device.
The gloves are designed and manufactured in accordance with the ASTM D6319-10 standard and are tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019)
The document describes the non-clinical testing performed to demonstrate that the Nitrile Patient Examination Gloves (K221747) meet their acceptance criteria and are substantially equivalent to a predicate device (K211220).
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319-19 | Physical Dimension | The actual measured dimension of the gloves shall meet the stated tolerance specified in Table 2 of ASTM D6319-19. | Meet the requirement |
| ASTM D6319-19 | Determination of Physical Properties | Before and after accelerated aging, the gloves shall conform to the physical requirements in Table 3 of ASTM 6319-19 (Tensile Strength: Before Aging ≥ 14 MPa, After Aging ≥ 14 MPa. Elongation: Before Aging 500%, After Aging 400%). | Meet the requirement |
| ASTM D5151-19 | Water Leak Test for Detection of Holes | The gloves shall be free from hole when tested in accordance with the method given in ASTM D5151-19, AQL = 2.5. | Meet the requirement |
| ASTM D6124-06(2017) | Residual Powder Content Test | The powder residue content shall be not more than 2mg per glove. | Meet the requirement |
| ISO 10993-5: 2009 | In Vitro Cytotoxicity | The MEM test extract shows no cytotoxic potential to L929 mouse fibroblast cells. | Meet the requirement |
| ISO 10993-10: 2010 | Skin Sensitization | The test article extracts show no evidence of causing delayed dermal contact sensitization in the guinea pig. | Meet the requirement |
| ISO 10993-10: 2010 | Skin Irritation | There is no erythema and no edema observed on the skin of the animals treated with the test extracts. | Meet the requirement |
| ASTM D6978-05 (Chemotherapy Drugs) | Chemotherapy Drugs (Permeation Breakthrough Time) | Carboplatin, 10 mg/ml >240 min.Carmustine (BCNU), 3.3 mg/ml 27.5 minCisplatin, 1.0 mg/ml >240 minCyclophosphamide (Cytoxan), 20.0 mg/ml >240 minDoxorubicin HCl, 2.0 mg/ml >240 minEtoposide, 20.0 mg/ml >240 minFluorouracil, 50.0 mg/ml >240 minPaclitaxel, 6.0 mg/ml >240 minThio Tepa, 10.0 mg/ml 88.2 min | Except for Carmustine and Thio Tepa, acceptance criteria were met. |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample sizes for each specific test within the non-clinical testing. It generally refers to "Final finished product" as the tested sample. The data provenance is not specified, but it can be inferred that the testing was conducted by or on behalf of the manufacturer, Fitone Latex Products Co., Ltd. Guangdong, which is based in China. The nature of the tests (physical, chemical, and biocompatibility) suggests these were laboratory-based tests on manufactured product samples. The document does not indicate if the data is retrospective or prospective, though it is standard practice for such tests to be prospective assessments of newly manufactured products.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the tests described are non-clinical, objective measurements against established ASTM and ISO standards for material properties and performance. There is no human interpretation or expert ground truth establishment for these types of tests (e.g., measuring glove dimensions, tensile strength, or chemical permeation).
4. Adjudication method for the test set:
This information is not applicable for the same reason as point 3. Adjudication methods are typically used in studies involving human interpretation or subjective assessments.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable. The submission is for a medical glove, not an AI-powered diagnostic device. Therefore, no MRMC study or AI assistance comparison was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not applicable as the device is not an algorithm or AI-based system.
7. The type of ground truth used:
The "ground truth" for the non-clinical tests is based on established industry standards and specifications:
- ASTM D6319-19 (Standard Specification for Nitrile Examination Gloves for Medical Application)
- ASTM D5151-19 (Test Method for Detection of Holes in Medical Gloves)
- ASTM D6124-06(2017) (Test Method for Residual Powder on Medical Gloves)
- ASTM D573-04(2019) (Test Method for Rubber-Deterioration in an Air Oven)
- 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)
- ASTM D6978-05 (Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs)
These standards define the acceptance criteria (e.g., minimum tensile strength, maximum residual powder, breakthrough times for chemotherapy drugs).
8. The sample size for the training set:
This information is not applicable as there is no training set for a medical glove. These are physical products tested against predetermined specifications.
9. How the ground truth for the training set was established:
This information is not applicable as there is no training set.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
December 1, 2022
Fitone Latex Products Co., Ltd. Guangdong % Stuart Situ Director Landlink Healthcare Technology (Shanghai) Co., Ltd. Room 1308, Baohua International Plaza 555 West Guangzhong Road Shanghai, 200072 China
Re: K221747
Trade/Device Name: Nitrile Patient 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: November 2, 2022 Received: November 2, 2022
Dear Stuart Situ:
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.
{1}------------------------------------------------
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 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-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).
Sincerelv.
Bifeng Qian -S
Bifeng Oian, 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 Ouality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K221747
Device Name
Nitrile Patient Examination Gloves Tested For Use With Chemotherapy Drugs
Indications for Use (Describe)
The nitrile examination glove is intended to be worn on the examiner's hand to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.
These gloves were tested for use with chemotherapy drugs per ASTM D6978-05 (2019)Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Tested chemotherapy drugs are as follows: Carboplatin, 10 mg/ml >240 min. Carmustine (BCNU), 3.3 mg/ml 27.5 min Cisplatin, 1.0 mg/ml >240 min Cyclophosphamide (Cytoxan), 20.0 mg/ml >240 min Doxorubicin HCI, 2.0 mg/ml >240 min Etoposide, 20.0 mg/ml >240 min Fluorouracil, 50.0 mg/ml >240 min Paclitaxel, 6.0 mg/ml >240 min Thio Tepa, 10.0 mg/ml 88.2 min
Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 27.5 Minutes, Thio Tepa 10.0 mg/ml 88.2 Minutes.
Warning: Please do not use with Carmustine and Thio Tepa.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| 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."
{3}------------------------------------------------
510(k) Summary K221747
I. Submitter
Fitone Latex Products Co., Ltd. Guangdong No.5 Huitong road, Lingbei Industrial Zone, Suixi, 524338 Zhanjiang, Guangdong, China
Contact person: Christine Ou Position: Manager Tel.: 0759-7905808 E-mail: market-intl@fitonelatex.com
Preparation date: Dec.1 2022
Submission Correspondent
Ms. Stuart Situ Landlink Healthcare Technology (Shanghai) Co., Ltd. E-mail: stuart.situ@landlink-healthcare.com
US Agent
Qihui Zhang ZYPPEL LLC 1337 Massachusetts Avenue #158 Arlington MA, MA US 02476
II. Proposed Device
| Device Trade Name: | Nitrile Patient Examination Gloves Tested For UseWith Chemotherapy Drugs |
|---|---|
| Model: | NG101 |
| Common name: | Patient Examination Glove (Tested For Use WithChemotherapy Drugs) |
| Regulation Number: | 21 CFR 880.6250 |
| Regulatory Class: | Class I |
| Product code: | LZA, LZC, OPJ |
| Review Panel: | General Hospital |
{4}------------------------------------------------
III. Predicate Devices
| 510(k) Number: | K211220 |
|---|---|
| Trade name: | Nitrile Patient Examination Gloves Blue Tested For UseWith Chemotherapy Drugs |
| Common name: | Patient Examination Glove (Tested For Use WithChemotherapy Drugs) |
| Classification: | Class I |
| Product Code: | LZA, LZC, OPJ |
| Manufacturer | GUANGDONG KINGFA SCI.&TECH.CO.,LTD. |
IV. Device description
The proposed device (Mode: NG101) is powder free nitrile examination gloves, provided as non-sterile and disposable device. The proposed devices are blue color and there are five sizes, include XS (6.5"), S (7"), M (8"), L (8.5"), XL (9") for optional. The examination glove is smooth surface with textured fingertips and a rolled rim at the cuff edge. This is a single-use, powder-free, non-sterile device.
The gloves are designed and manufactured in accordance with the ASTM D6319-10 standard and are tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019)
V. Indication for use
The nitrile examination glove is intended to be worn on the examiner's hand to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.
These gloves were tested for use with chemotherapy drugs per ASTM D6978-05 (2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Tested chemotherapy drugs are as follows:
Carboplatin, 10 mg/ml >240 min.
Carmustine (BCNU), 3.3 mg/ml 27.5 min
Cisplatin, 1.0 mg/ml >240 min
Cyclophosphamide (Cytoxan), 20.0 mg/ml >240 min
{5}------------------------------------------------
Doxorubicin HCI, 2.0 mg/ml >240 min Etoposide, 20.0 mg/ml >240 min Fluorouracil, 50.0 mg/ml >240 min Paclitaxel, 6.0 mg/ml >240 min Thio Tepa, 10.0 mg/ml 88.2 min
- · Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 27.5 Minutes; Thio Tepa 10.0 mg/ml 88.2 Minutes.
- · Warning: Please do not use with Carmustine and Thio Tepa.
VI. Comparison of technological characteristics with the predicate devices
| Item | Proposed device(K221747) | Predicate device(K211220) | Discussion |
|---|---|---|---|
| Product name | Nitrile PatientExamination GlovesTested For Use WithChemotherapy Drugs | Nitrile PatientExamination GlovesBlue Tested For UseWith ChemotherapyDrugs | - |
| Product Code | LZA, LZC, OPJ | LZA, LZC, OPJ | Same |
| RegulationNo. | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Classification | Class I | Class I | Same |
| Powder free | Yes | Yes | Same |
Table 1 Comparison of Nitrile Patient Examination Gloves
{6}------------------------------------------------
| Indicationfor use | Similar¹ | ||
|---|---|---|---|
| The nitrile examinationglove is a disposabledevice intended formedical purposes that isworn on the examiner'shand to preventcontamination betweenpatient and examiner.These gloves weretested for use withChemotherapy drugs asper ASTM D6978-05(Reapproved 2019)Standard Practice forAssessment of MedicalGloves of Permeation byChemotherapy Drugs | A patient examinationglove is a disposabledevice intended formedical purposes that isworn on the examiner'shand to preventcontamination betweenpatient and examiner.These gloves weretested for use withChemotherapy drugsas per ASTM D6978-05(Reapproved 2019) Standard Practicefor Assessment of Medical Gloves ofPermeation byChemotherapy Drugs | ||
| Main | Powder-Free Nitrile | Powder-Free Nitrile | Same |
| Material | |||
| Color | Blue | Blue | Same |
| Size | X-small, Small, Medium,Large, X large | small, medium, large, x-large | Similar² |
| Dimensions–Length | Complies with ASTMD6319-19XS (220mm min)S (220mm min)M (230mm min)L (230mm min)XL (230mm min) | Complies with ASTMD6319-19S (220mm min)M (230mm min)L (230mm min)XL (230mm min) | Similar² |
| Dimensions–Width | Complies with ASTMD6319-19XS (70±10mm)S (80±10mm)M (95±10mm)L (110±10mm)XL (120±10mm) | Complies with ASTMD6319-19Small (80±10mm)Medium (95±10mm)Large (110±10mm)X large (120±10mm) | Similar² |
| Dimensions–Thickness | Complies with:ASTM D6319-19Palm: 0.05mm minFinger: 0.08mm min | Complies with:ASTM D6319-19Palm: 0.05mm minFinger: 0.11mm min | Similar² |
| PhysicalProperties | Complies with:ASTM D6319-19minimum:Tensile Strength:Before Aging ≥ 14 MPa,min.After Aging ≥ 14 MPa,min.Elongation:Before Aging 500%, min.After Aging 400%, min. | Complies with:ASTM D6319-19minimum:Tensile Strength:Before Aging ≥14 MPa,min.After Aging ≥ 14 MPa,min.Elongation:Before Aging 500%,min.After Aging 400%, min. | Same |
| FreedomfromHoles | The gloves shall be freefrom hole when tested inaccordance with themethod given in ASTMD5151 | The gloves shall be freefrom hole when tested inaccordance with themethod given in ASTMD5151 | Same |
| Powder orPowder-Free | Powder-Free | Powder-Free | Same |
| ResidualPowder | Complies with:ASTM D6319-19<2mg per glove | Complies with:ASTM D6319-19<2mg per glove | Same |
| Surface | Smooth surface withtextured fingertips | Smooth surface | Similar³ |
| ContactDurations | Limited <24 hours | Limited <24 hours | Same |
| Biocompatibility | AAMI/ANSI/ISO 10993-10:Not a skin irritantNot a skin sensitizer | AAMI/ANSI/ISO 10993-10:Not a skin irritantNot a skin sensitizer | Same |
| AAMI/ANSI/ISO 10993-5:The test article was non-cytotoxic to L-929 cells | AAMI/ANSI/ISO 10993-5:At the neat extraction, the test article isconsidered cytotoxic | Different4 | |
| / | The acute systemictoxicity resultsdemonstrate the devicewill not cause asystemic effect | Different4 | |
| Sterility | Non-sterile | Non-sterile | Same |
| Rx Only orOTC | Over the Counter | Over the Counter | Same |
| Chemotherapy DrugsTested withMinimumBreakthrough DetectionTime asTested perASTMD6978 | Carboplatin, 10mg/ml >240 min.Carmustine (BCNU), 3.3mg/ml 27.5 minCisplatin, 1.0 mg/ml >240minCyclophosphamide(Cytoxan), 20.0mg/ml >240 minDoxorubicin HCl, 2.0mg/ml >240 minEtoposide, 20.0mg/ml >240 minFluorouracil, 50.0mg/ml >240 minPaclitaxel, 6.0mg/ml >240 minThio Tepa, 10.0 mg/ml88.2 min | Carmustine (BCNU) 3.3mg/ml 65.3 minutesCisplatin 1.0mg/ml >240 minutesCyclophosphamide(Cytoxan) 20.0mg/ml >240 minutesDacarbazine (DTIC)10.0mg/ml >240 minutesDoxorubicinHydrochloride 2.0mg/ml >240 minutesEtoposide (Toposar)20.0 mg/ml >240minutesFluorouracil 50.0mg/ml >240 minutesPaclitaxel (Taxol) 6.0mg/ml >240 minutesThiotepa 10.0 mg/ml58.3minutes | Similar |
{7}------------------------------------------------
{8}------------------------------------------------
1Except the device name, the contents of indications for use are identical.
²As above comparison, the difference in the dimensions between the subject and predicate devices does not raise additional questions for safety and effectiveness of the device.
{9}------------------------------------------------
3The surface of the fingertips of the proposed device and predicate device is different. Fingers of the proposed device are textured. However, the thickness or other performance of the proposed device complies with ASTM D6319-19. Therefore, the difference does not raise additional questions for safety and effectiveness of the device.
4The Cytotoxicity test result of proposed device and predicate device is different. The test result of proposed device showed no cytotoxic potential to L929 mouse fibroblast cells. Acute systemic toxicity test is not necessary for the proposed device.
VII. Non-Clinical Testing
Non clinical tests were conducted in accordance with following standards to verify that the proposed device met all design specifications.
- . ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application
- ASTM D5151-19, Test Method for Detection of Holes in Medical Gloves .
- ASTM D6124-06(2017), Test Method for Residual Powder on Medical Gloves .
- ASTM D573-04(2019), Test Method for Rubber-Deterioration in an Air Oven ●
- 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.
- ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical . Gloves to Permeation by Chemotherapy Drugs
| TestMethodology | Tested sample | Purpose | Acceptance Criteria | Results |
|---|---|---|---|---|
| ASTMD6319-19 | Final finishedproduct | PhysicalDimension | The actualmeasureddimension of thegloves shall bemeet the statedtolerancespecified in Table | Meet therequirement |
| 2 of the ASTM D6319-19 | ||||
| ASTMD6319-19 | Final finishedproduct | Determination ofPhysicalProperties | Before and afteraccelerated aging,the gloves shallconform to thephysicalrequirements inthe Table 3 ofASTM 6319-19) | Meet therequirement |
| ASTMD5151-19 | Final finishedproduct | Water Leak Testfor Detection ofHoles | The gloves shallbe free from holewhen tested inaccordance withthe method givenin ASTM D5151 -19$AQL =2.5$ | Meet therequirement |
| ASTMD6124-06(2017) | Final finishedproduct | Residual PowderContent Test | The powderresidue contentshall be not morethan 2mg pergloves. | Meet therequirement |
| ISO 10993-5: 2009 | Final finishedproduct | In VitroCytotoxicity | The MEM testextract shows nocytotoxic potentialto L929 mousefibroblast cells. | Meet therequirement |
| ISO 10993-10: 2010 | Final finishedproduct | Skin Sensitization | The test articleextracts show noevidence ofcausing delayeddermal contactsensitization in theguinea pig. | Meet therequirement |
| ISO 10993-10: 2010 | Final finishedproduct | Skin irritation | There is noerythema and noedema observedon the skin of theanimals treatedwith the testextracts | Meet therequirement |
| ASTM D6978-05 | Final finished product | Chemotherapy Drugs | Carboplatin, 10 mg/ml >240 min.Carmustine (BCNU), 3.3 mg/ml 27.5 minCisplatin, 1.0 mg/ml >240 minCyclophosphamide (Cytoxan), 20.0 mg/ml >240 minDoxorubicin HCl, 2.0 mg/ml >240 minEtoposide, 20.0 mg/ml >240 minFluorouracil, 50.0 mg/ml >240 minPaclitaxel, 6.0 mg/ml >240 minThio Tepa, 10.0 mg/ml88.2 min | Except for Carmustine and Thio Tepa, acceptance criteria were met. |
{10}------------------------------------------------
{11}------------------------------------------------
VIII. Clinical Testing
No clinical study is included in this submission.
IX. Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in this 510(K) submission, the Nitrile Patient Examination Glove is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K211220.
§ 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.