(92 days)
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs.
The subject device is single use, disposable gloves intended for medical purposes to be worn on the examiner's hands to prevent contamination between patient and examiner. The gloves are powder-free, ambidextrous with beaded cuff, blue colored, nitrile, and tested for use with chemotherapy drugs. The gloves are offered in four sizes: small, medium, large, and extra-large. The subject device is non-sterile.
Acceptance Criteria and Device Performance for Disposable Nitrile Examination Gloves
This document outlines the acceptance criteria and details the studies conducted to demonstrate that the "Disposable Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)" meet these criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test | Length (mm): S: ≥220; M/L/XL: ≥230Width (mm): S: 80±10; M: 95±10; L: 110±10; XL: 120±10Thickness (mm): Finger: ≥0.05; Palm: ≥0.05 | Length (mm): > 240/Pass (for all sizes)Width (mm): S: 88-89 /Pass; M: 94-97/ Pass; L: 103-107/Pass; XL: 114-116/PassThickness (mm): Finger: 0.10-0.11/Pass; Palm: 0.07-0.08/Pass |
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 | 0/125/Pass |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 << 2.0mg | 0.08mg/Pass |
| ASTM D412 | Physical properties (Tensile Strength & Elongation) | Before Aging: Tensile Strength ≥14MPa; Ultimate Elongation ≥500%After Aging: Tensile Strength ≥14MPa; Ultimate Elongation ≥400% | Before Aging: Tensile Strength: 21.5-29.0MPa/Pass; Ultimate Elongation: 796-983%/PassAfter Aging: Tensile Strength: 19.1-25.9MPa/Pass; Ultimate Elongation: 645-904%/Pass |
| ISO 10993-5 | Cytotoxicity | Under conditions of the study, device extract is not cytotoxic. | Under conditions of the study, device extract is not cytotoxic. /Pass |
| ISO 10993-10 | Irritation | Non-irritating | Under the conditions of the study, not an irritant. / Pass |
| ISO 10993-10 | Sensitization | Non-sensitizing | Under conditions of the study, not a sensitizer. / Pass |
| ASTM D6978-05 | Chemotherapy Drug Permeation (Minimum Breakthrough) | Carmustine (BCNU) 3.3 mg/ml: > 20 Minutes (Predicate's acceptance criteria was >20 minutes, though the predicate showed 11.8 min and 31.6 min depending on color - subject device had 1.9 min, leading to a warning for this drug).Cisplatin 1.0 mg/ml: > 20 MinutesCyclophosphamide (Cytoxan) 20.0 mg/ml: > 240 MinutesDacarbazine (DTIC) 10.0 mg/ml: > 240 MinutesDoxorubicin HCl 2.0 mg/ml: > 240 MinutesEtoposide 20.0 mg/ml: > 240 MinutesFluorouracil 50.0 mg/ml: > 240 MinutesPaclitaxel 6.0 mg/ml: > 20 Minutes (Predicate's acceptance criteria was >20 minutes, though the predicate showed >240 min).ThioTepa 10.0 mg/ml: > 20 Minutes (Predicate's acceptance criteria was >20 minutes though the subject device had 11.3 min, leading to a warning for this drug). | Carmustine (BCNU) 3.3 mg/ml: 1.9 Minutes (Warning: Do not use)Cisplatin 1.0 mg/ml: > 240 MinutesCyclophosphamide (Cytoxan) 20.0 mg/ml: > 240 MinutesDacarbazine 10.0 mg/ml: > 240 MinutesDoxorubicin HCL 2.0 mg/ml: > 240 MinutesEtoposide 20.0 mg/ml: > 240 MinutesFluorouracil 50.0 mg/ml: > 240 MinutesPaclitaxel 6.0 mg/ml: > 240 MinutesThioTepa 10.0 mg/ml: 11.3 Minutes (Warning: Do not use) |
Note: For Carmustine (BCNU) and ThioTepa, the device performance did not meet the implicitly accepted longer breakthrough times of the predicate device for safe use, and as such, a warning was issued for non-use with these specific drugs. For other drugs, the device demonstrated comparable or superior performance to the predicate.
2. Sample Size and Data Provenance
The document does not explicitly state the specific sample sizes used for each test. However, for the Watertightness Test (ASTM D5151), the result "0/125/Pass" indicates a sample size of 125 gloves were tested, and none failed.
The data provenance is implied to be prospective bench testing conducted specifically for the submission of this device, presumably within China, given the manufacturer's and correspondent's addresses. There is no information provided regarding country of origin of data beyond the manufacturer's location.
3. Number of Experts and Qualifications for Ground Truth
This section is not applicable as the studies are primarily bench testing of physical and chemical properties of a medical device (gloves). The "ground truth" for these tests is established by published ASTM and ISO standards and their specified methodologies, not by expert consensus on diagnostic images or clinical outcomes.
4. Adjudication Method for the Test Set
This is not applicable as the studies involve objective physical and chemical testing against established standards, not interpretation of data requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This is not applicable. The device is a medical glove, and the evaluation does not involve diagnostic imaging or human-in-the-loop performance with AI.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This is not applicable. The device is a medical glove, not an algorithm, and its performance is assessed directly through physical and chemical testing.
7. Type of Ground Truth Used
The ground truth used for these studies is based on:
- Established ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards: These standards define the test methodologies, performance criteria (e.g., minimum tensile strength, maximum powder content, minimum breakthrough times for chemotherapy drugs, irritation/sensitization levels), and acceptable limits.
- Objective laboratory measurements: Physical dimensions, tensile strength, elongation, watertightness, powder content, and chemical permeation breakthrough times were measured directly according to the specified standard test methods.
8. Sample Size for the Training Set
This is not applicable. The device is a physical product (medical gloves), not an AI algorithm that requires a training set. The performance is based on direct testing of the product itself.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set for this type of device. The "ground truth" for the performance evaluation is established by the relevant ASTM and ISO standards as mentioned in point 7.
{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. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 15, 2021
Jiujiang Taixin Technology Co., Ltd. % Boyle Wang Official Correspondent Shanghai Truthful information Technology Co., Ltd. RM. 1801, No. 161 Lujiazui East Rd.,Pudong Shanghai. 200120 China
Re: K212919
Trade/Device Name: Disposable 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 Dated: September 7, 2021 Received: September 14, 2021
Dear Boyle Wang:
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).
Sincerely.
For Clarence W. Murray, III, PhD 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
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K212919
Device Name
Disposable Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)
Indications for Use (Describe)
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs.
| Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes |
|---|---|---|
| Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 1.9 Minutes |
| Cisplatin | 1.0 mg/ml(1,000 ppm) | > 240 Minutes |
| Cyclophosphamide (Cytoxan) | 20.0 mg/ml(20,000 ppm) | > 240 Minutes |
| Dacarbazine | 10.0 mg/ml(10,000 ppm) | > 240 Minutes |
| Doxorubicin HCL | 2.0 mg/ml(2,000 ppm) | > 240 Minutes |
| Etoposide | 20.0 mg/ml(20,000 ppm) | > 240 Minutes |
| Fluorouracil | 50.0 mg/ml(50,000 ppm) | > 240 Minutes |
| Paclitaxel | 6.0 mg/ml(6,000 ppm) | > 240 Minutes |
| ThioTepa | 10.0 mg/ml(10,000 ppm) | 11.3 Minutes |
Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 1.9 Minutes ThioTepa 10.0 mg/ml 11.3 Minutes
Warning: Please do not use with Carmustine (BCNU) and 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."
{3}------------------------------------------------
510(k) Summary
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter's Information_
Name: Jiujiang Taixin Technology Co., Ltd.
Address: Zone A, Ruichang Science and Technology Park, Ruichang City, Jiangxi Province, P.R. China.
Contact: Li Xiaojie
Date of Preparation: Sept 7, 2021
Designated Submission Correspondent
Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 1801, No. 161 Lujiazui East Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn
2.0 Device Information
- Trade name: Disposable Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)
- Common name: Patient Examination Gloves
Classification name: Non-powdered patient examination glove
Model(s): S, M, L, XL
{4}------------------------------------------------
3.0 Classification
Production code: LZA,LZC
Regulation number: 21CFR880.6250
Classification: Class I
General Hospital Panel:
4.0 Predicate Device Information
Manufacturer: Ever Growth (Vietnam) Co., Ltd.
- Device: Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, Orange Color
510(k) number: K190860
5.0 Device Description
The subject device is single use, disposable gloves intended for medical purposes to be worn on the examiner's hands to prevent contamination between patient and examiner. The gloves are powder-free, ambidextrous with beaded cuff, blue colored, nitrile, and tested for use with chemotherapy drugs. The gloves are offered in four sizes: small, medium, large, and extra-large.
The subject device is non-sterile.
6.0 Indication for Use
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were
{5}------------------------------------------------
tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs
| Chemotherapy Drug | Concentration | Breakthrough DetectionTime in Minutes |
|---|---|---|
| Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 1.9 |
| Cisplatin | 1.0 mg/ml(1,000 ppm) | > 240 |
| Cyclophosphamide(Cytoxan) | 20.0 mg/ml(20,000 ppm) | > 240 |
| Dacarbazine (DTIC) | 10.0 mg/ml(10,000 ppm) | > 240 |
| Doxorubicin HCI | 2.0 mg/ml(2,000 ppm) | > 240 |
| Etoposide | 20.0 mg/ml(20,000 ppm) | > 240 |
| Fluorouracil | 50.0 mg/ml(50,000 ppm) | > 240 |
| Paclitaxel | 6.0 mg/ml(6,000 ppm) | > 240 |
| ThioTepa | 10.0 mg/ml(10,000 ppm) | 11.3 |
Please note that the following drugs have low permeation times:
Carmustine (BCNU) 3.3 mg/ml 1.9 Minutes;
Thio Tepa 10.0 mg/ml 11.3 Minutes.
Warning: Please do not use with Carmustine (BCNU) and ThioTepa.
7.0 Technological Characteristic Comparison Table
| ltem | Subject Device(K212919) | Predicate Device(K190860) | Comparison |
|---|---|---|---|
| Product Code | LZA,LZC | LZA,LZC | Same |
Table1-General Comparison
{6}------------------------------------------------
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same | |
|---|---|---|---|---|
| Class | I | I | Same | |
| Intended Use | A patient examinationgloves is a disposabledevice intended for medicalpurpose that is worn on theexaminer's hand orfingers to preventcontamination betweenpatient and examiner. Inaddition, these gloves weretested for use withchemotherapy drugs inaccordance with ASTMD6978-05 StandardPractice for Assessment ofMedical gloves toPermeation byChemotherapy Drugs. | A patient examinationgloves is a disposabledevice intended for medicalpurpose that is worn on theexaminer's hand orfingers to preventcontamination betweenpatient and examiner. Inaddition, these gloves weretested for use withchemotherapy drugs inaccordance with ASTMD6978-05 StandardPractice for Assessment ofMedical gloves toPermeation byChemotherapy Drugs. | Same | |
| Powdered or Poweredfree | Powdered free | Powdered free | Same | |
| Design Feature | Ambidextrous | Ambidextrous | Same | |
| Sterility | Non-Sterile | Non-Sterile | Same | |
| Labeling Information | Single-use indication,powder free, device color,device name, glove size andquantity,Non-Sterile,a statement of standardASTM D6978-05compliance and asummary of the testingresults. | Single-use indication,powder free, device color,device name, glove sizeand quantity, Non-Sterile, astatement of standardASTM D6978-05compliance and asummary of the testingresults. | Same | |
| Dimensions(mm) | Length:S: ≥220; | Length:XS/S/M/L/XL: ≥230; | Similar | |
| M/L/XL: ≥230;Width:S: 80±10;M: 95±10;L: 110±10;XL: 120±10 | Width:XS:70±10;S: 80±10;M: 95±10;L: 110±10;XL: 120±10 | |||
| Thickness(mm) | Finger: ≥0.05;Palm: ≥0.05 | Finger: ≥0.05;Palm: ≥0.05 | Same | |
| Colorant | Blue | White, Orange | Different | |
| PhysicalProperties | BeforeAging | TensileStrength 14MPa, minUltimateeElongation 500% min | TensileStrength 14MPa, minUltimateElongation 500% min | Same |
| AfterAging | TensileStrength 14MPa, minUltimateeElongation 400%min | TensileStrength 14MPa, minUltimateElongation 400%min | Same | |
| Freedom from Holes | Be free from holes whentested in accordance withASTMD5151 AQL=2.5 | Same | ||
| Powder Content | 0.15 mg per glove, Meetthe requirements ofASTM D6124 | Similar | ||
| Biocompatibility | ISO 10993-10;Under the conditions ofthe study, not an irritant | Same | ||
| or a sensitizer | or a sensitizer | |||
| ISO 10993-5 | ISO 10993-5 | |||
| Under conditions of thestudy, device extract isnot cytotoxic | Under conditions of thestudy, device extract isnot cytotoxic | Same | ||
| Carmustine (BCNU) 3.3mg/ml: 1.9 Minutes | Carmustine (BCNU) 3.3mg/ml:White: 11.8 Minutes;Orange: 31.6Minutes | Similar | ||
| Cisplatin 1.0 mg/ml: > 20Minutes | Cisplatin 1.0 mg/ml: >20Minutes | Same | ||
| Chemotherapy DrugsTested with MinimumBreakthrough | Cyclophosphamide(Cytoxan) 20.0 mg/ml: >240 Minutes | Cyclophosphamide(Cytoxan)20.0 mg/ml: >240 Minutes | Same | |
| Dacarbazine (DTIC) 10.0mg/ml: > 240 Minutes | Dacarbazine (DTIC) 10.0mg/ml:>240 Minutes | Same | ||
| Doxorubicin HCl 2.0 mg/ml:> 240 Minutes | Doxorubicin Hydrochloride2.0mg/ml: >240 Minutes | Same | ||
| Etoposide 20.0 mg/ml: >240 Minutes | Etoposide (Toposar) 20.0mg/ml: >240 Minutes | Same | ||
| Fluorouracil 50.0 mg/ml: >240 Minutes | Fluorouracil 50.0mg/ml: >240Minutes | Same | ||
| Paclitaxel 6.0 mg/ml: >20Minutes | Paclitaxel (Taxol) 6.0mg/ml:>240 Minutes | Same |
{7}------------------------------------------------
{8}------------------------------------------------
{9}------------------------------------------------
| Detection Time asTested per ASTM D6978 | |||
|---|---|---|---|
| ------------------------------------------------ | -- | -- | -- |
8.0 Summarv of Non-Clinical Testing
Biocompatibility Testing
The biocompatibility evaluation for Medical Examination Gloves (Tested for Use with Chemotherapy) was conducted in accordance with the following standards:
ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests for Irritation And Skin Sensitization.
ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
Performance Testing (Bench)
Physical performance qualities of the proposed device were evaluated per ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application.
Permeation testing was conducted to support the addition of the labeling claim: Tested for use with chemotherapy drugs. In addition, the proposed device was tested according to ASTM D6978-05 (Reapproved 2019), Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs, in which minimum breakthrough times were determined for a wide range of chemotherapy drugs.
In summary, the performance testing of the subject device was conducted to adequately demonstrate the effectiveness of the device in accordance with the relevant test methods cited below:
{10}------------------------------------------------
- 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 D 6978-05 (Reapproved 2019), Standard Practice for । Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
| TestMethod | Purpose | Acceptance Criteria | Results | ||||
|---|---|---|---|---|---|---|---|
| ASTMD6319 | PhysicalDimensionsTest | Length(mm):S:≥220;M/L/XL:≥230; | Length(mm):> 240/Pass; | ||||
| Width(mm):S: 80±10;M: 95±10;L: 110±10;XL: 120±10 | Width(mm):S: 88-89 /PassM: 94-97/ PassL: 103-107/PassXL:114-116/Pass | ||||||
| Thickness (mm):Finger: ≥0.05Palm: ≥0.05 | Thickness (mm):Finger: 0.10-0.11/PassPalm: 0.07-0.08/Pass | ||||||
| ASTMD5151 | WatertightnessTestforDetectionofHoles | Meet the requirements of ASTM D5151AQL 2.5 | 0/125/Pass | ||||
| ASTMD6124 | PowderContent | Meet the requirements of ASTM D6124 <2.0mg | 0.08mg/Pass; | ||||
| ASTM | Physical | Before Tensile ≥14MPa | 21.5-29.0MPa/Pass; |
Table 2 - Summary of non-clinical performance testing
{11}------------------------------------------------
| D412 | properties | Aging | Strength | ||
|---|---|---|---|---|---|
| UltimateElongation | ≥500% | 796-983%/Pass; | |||
| AfterAging | TensileStrength | ≥14MPa | 19.1-25.9MPa/Pass; | ||
| UltimateElongation | ≥400% | 645-904%/Pass; | |||
| ISO10993-5 | Cytotoxicity | Non- In Vitro Cytotoxicity | Under conditions ofthe study, deviceextract is notcytotoxic. /Pass | ||
| ISO10993-10 | Irritation | Non-irritating | Under the conditionsof the study, not anirritant. / Pass | ||
| ISO10993-10 | Sensitization | Non-sensitizing | Under conditions ofthe study, not asensitizer. / Pass |
9.0 Summary of Clinical Testing
Clinical testing is not needed for this device.
10.0 Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject device, Disposable 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 predicated device under K190860.
§ 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.