(87 days)
Not Found
No
The 510(k) summary describes a standard medical examination glove and its physical and chemical resistance properties. There is no mention of AI or ML technology in the intended use, device description, performance studies, or key metrics. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
The device is a patient examination glove, intended to prevent contamination and for use with chemotherapy drugs, not to treat a disease or condition.
No
This device is a medical glove, designed to prevent contamination. It does not gather information to indicate the presence or absence of a disease or condition, which is the function of a diagnostic device. Its testing relates to physical properties and chemical permeation, not diagnostic accuracy.
No
The device description clearly states it is a physical, disposable glove made of nitrile, intended to be worn on the hand. It undergoes physical and chemical performance testing, not software validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner." This is a barrier device for protection, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
- Device Description: The description focuses on the physical characteristics and material of the gloves, and their testing for chemotherapy drug permeation. This aligns with a protective barrier device.
- Performance Studies and Key Metrics: The performance studies and key metrics presented are related to the physical properties, biocompatibility, and chemical resistance of the gloves (e.g., tensile strength, watertightness, breakthrough time for chemotherapy drugs). These are not diagnostic performance metrics like sensitivity, specificity, or AUC, which are typical for IVD devices.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
In summary, the device's function is to provide a physical barrier for protection, not to perform diagnostic testing on biological specimens.
N/A
Intended Use / Indications 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 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 |
|---|---|---|
| Carboplatin | 10.0 mg/ml(10,000 ppm) | > 240 Minutes |
| Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 35.2 Minutes |
| Cyclophosphamide (Cytoxan) | 20.0 mg/ml(20,000 ppm) | > 240 Minutes |
| Doxorubicin | 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 |
| Methotrexate | 25.0 mg/ml(25,000 ppm) | > 240 Minutes |
| Paclitaxel | 6.0 mg/ml(6,000 ppm) | > 240 Minutes |
| ThioTepa | 10.0 mg/ml(10,000 ppm) | 76.3 Minutes |
Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 35.2 Minutes ThioTepa 10.0 mg/ml 76.3 Minutes
Warning: Please do not use with Carmustine (BCNU) and ThioTepa.
Product codes
LZA, LZC
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 six sizes: XS, S, M, L, XL, XXL. The subject device is non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hands or fingers
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Examiner (medical purposes)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility Testing
The biocompatibility evaluation for Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs) 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
Results:
- ISO 10993-5: Under conditions of the study, device extract is not cytotoxic. /Pass
- ISO 10993-10 (Irritation): Under the conditions of the study, not an irritant. / Pass
- ISO 10993-10 (Sensitization): Under conditions of the study, not a sensitizer. / Pass
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.
Relevant test methods cited:
- 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 (Reapproved 2019), Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
Results:
- ASTM D6319 (Physical Dimensions Test):
- Length(mm): XS: ≥220; S/M/L/XL/XXL: ≥230; Results: > 240/Pass
- Width(mm): XS: 70±10; S: 80±10; M: 95±10; L: 110±10; XL: 120±10; XXL: 130±10; Results: XS: 67-72/Pass, S: 76-83/Pass, M: 91-99/ Pass, L: 106-112/ Pass, XL:116-124/ Pass, XXL: 127-134/ Pass
- Thickness (mm): Finger: ≥0.05; Palm: ≥0.05; Results: Finger: 0.06-0.10/Pass, Palm: 0.07-0.10/Pass
- ASTM D5151 (Watertightness Test for Detection of Holes):
- Acceptance Criteria: Meet the requirements of ASTM D5151 AQL 2.5; Results: 0/125/Pass
- ASTM D6124 (Powder Content):
- Acceptance Criteria: Meet the requirements of ASTM D6124 240 Minutes
- Carmustine (BCNU) 3.3 mg/ml (3,300 ppm): 35.2 Minutes
- Cyclophosphamide (Cytoxan) 20.0 mg/ml(20,000 ppm): > 240 Minutes
- Doxorubicin 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
- Methotrexate 25.0 mg/ml(25,000 ppm): > 240 Minutes
- Paclitaxel 6.0 mg/ml(6,000 ppm): > 240 Minutes
- ThioTepa 10.0 mg/ml(10,000 ppm): 76.3 Minutes
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
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" followed by the words "U.S. Food & Drug Administration".
December 18, 2021
Yunnan Huazhiyuan Medical 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: K213051
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 Dated: September 16, 2021 Received: September 22, 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.
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
1
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,
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)
K213051
Device Name
Nitrile Patient 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 |
|---|---|---|
| Carboplatin | 10.0 mg/ml(10,000 ppm) | > 240 Minutes |
| Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 35.2 Minutes |
| Cyclophosphamide (Cytoxan) | 20.0 mg/ml(20,000 ppm) | > 240 Minutes |
| Doxorubicin | 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 |
| Methotrexate | 25.0 mg/ml(25,000 ppm) | > 240 Minutes |
| Paclitaxel | 6.0 mg/ml(6,000 ppm) | > 240 Minutes |
| ThioTepa | 10.0 mg/ml(10,000 ppm) | 76.3 Minutes |
Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 35.2 Minutes ThioTepa 10.0 mg/ml 76.3 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
K213051 510(k) Summary
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter's Information
Name: Yunnan Huazhiyuan Medical Technology Co., Ltd. Address: Yangije Industrial Park,Jianshui County,Honghe Hani and Yi Autonomous Prefecture, Yunnan Province,China Contact: Yun Gao Date of Preparation: Sept 16, 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
Nitrile Patient Examination Gloves (Tested for Use with Trade name: Chemotherapy Drugs) Common name: Patient Examination Gloves Classification name: Non-powdered patient examination glove Model(s): XS, S, M, L, XL, XXL
3.0 Classification
Production code: LZA.LZC Regulation number: 21CFR880.6250 Classification: Class I Panel: General Hospital
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
4
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 six sizes: XS, S, M, L, XL, XXL. 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 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 |
|----------------------------|------------------------|-------------------------------------------|
| Carboplatin | 10.0 mg/ml(10,000 ppm) | > 240 |
| Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 35.2 |
| Cyclophosphamide (Cytoxan) | 20.0 mg/ml(20,000 ppm) | > 240 |
| Doxorubicin | 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 |
| Methotrexate | 25.0 mg/ml(25,000 ppm) | > 240 |
| Paclitaxel | 6.0 mg/ml(6,000 ppm) | > 240 |
| ThioTepa | 10.0 mg/ml(10,000 ppm) | 76.3 |
Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 35.2 Minutes; Thio Tepa 10.0 mg/ml 76.3 Minutes.
Warning: Please do not use with Carmustine (BCNU) and ThioTepa.
7.0 Technological Characteristic Comparison Table
Table1-General Comparison
| Item | Subject Device | Predicate Device
(K190860) | Remark |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Product Code | LZA,LZC | LZA,LZC | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| Intended 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
tested for use with
chemotherapy drugs in
accordance with ASTM
D6978-05 Standard
Practice for Assessment of
Medical gloves to
Permeation by
Chemotherapy Drugs. | 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. | Same |
| Powdered or Powered
free | 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 and
quantity,Non-Sterile,
a statement of standard
ASTM D6978-05
compliance and a
summary of the testing
results. | Single-use indication,
powder free, device color,
device name, glove size
and quantity, Non-Sterile, a
statement of standard
ASTM D6978-05
compliance and a
summary of the testing
results. | Same |
| Dimensions(mm) | Length:
XS/S:≥220;
M/L/XL/XXL: ≥230;
Width:
XS: 70±10;
S: 80±10;
M: 95±10;
L: 110±10;
XL: 120±10;
XXL: 130±10 | Length:
XS/S/M/L/XL: ≥230;
Width:
XS:70±10;
S: 80±10;
M: 95±10;
L: 110±10;
XL: 120±10 | Similar |
5
6
| Palm: ≥0.05 | Palm: ≥0.05 | |||||
|---|---|---|---|---|---|---|
| Colorant | Blue | White, Orange | Different | |||
| Physical | ||||||
| Properties | Tensile | |||||
| Strengt | ||||||
| h | 14MPa, min | Tensile | ||||
| Strength | 14MPa, min | Same | ||||
| Before | ||||||
| Aging | Ultimat | |||||
| e | ||||||
| Elonga | ||||||
| tion | 500% min | Ultimate | ||||
| Elongatio | ||||||
| n | 500% min | Same | ||||
| After | Tensile | |||||
| Strengt | ||||||
| h | 14MPa, min | Tensile | ||||
| Strength | 14MPa, min | Same | ||||
| Aging | Ultimat | |||||
| e | ||||||
| Elonga | ||||||
| tion | 400%min | Ultimate | ||||
| Elongatio | ||||||
| n | 400%min | Same | ||||
| Freedom from Holes | Be free from holes when | |||||
| tested in accordance with | ||||||
| ASTMD5151 AQL=2.5 | Be free from holes when | |||||
| tested in accordance | ||||||
| with | ||||||
| ASTMD5151 | ||||||
| AQL=2.5 | ||||||
| Powder Content | 0.02 mg per glove, Meet | |||||
| the requirements of | ||||||
| ASTM D6124 | Meet the requirements of | |||||
| ASTM D6124 | Similar | |||||
| Biocompatibility | ISO 10993-10; | |||||
| Under the conditions of | ||||||
| the study, not an irritant | ||||||
| or a sensitizer | ISO 10993-10; | |||||
| or a sensitizer | Under the conditions of | |||||
| the study, not an irritant | Same | |||||
| ISO 10993-5 | ||||||
| Under conditions of the | ||||||
| study, device extract is | ||||||
| not cytotoxic | ISO 10993-5 | |||||
| not cytotoxic | Under conditions of the | |||||
| study, device extract is | Same | |||||
| Carboplatin 10.0 mg/ml: > | ||||||
| 240 Minutes | / | Different | ||||
| Carmustine (BCNU) | ||||||
| 3.3 | ||||||
| mg/ml: 35.2 Minutes | Carmustine (BCNU) 3.3 | |||||
| mg/ml: | ||||||
| White:11.8 Minutes; | ||||||
| Orange:31.6Minutes | Similar | |||||
| l | Cisplatin 1.0 mg/ml: >>240 | |||||
| Minutes | Different | |||||
| Cyclophosphamide | ||||||
| (Cytoxan) 20.0 mg/ml: |
240 Minutes | | Cyclophosphamide
(Cytoxan)
20.0 mg/ml: >240 Minutes | | Same |
| | | l | | Dacarbazine (DTIC) 10.0
mg/ml: | | Different |
7
| Chemotherapy Drugs
Tested with Minimum
Breakthrough
Detection Time as
Tested per ASTM D
6978 | Doxorubicin 2.0 mg/ml: >
240 Minutes | Doxorubicin Hydrochloride
2.0
mg/ml: >240 Minutes | Same |
|-------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|----------------------------------------------------------------------|-----------|
| | Etoposide 20.0 mg/ml: >
240 Minutes | Etoposide (Toposar) 20.0
mg/ml: >240 Minutes | Same |
| | Fluorouracil 50.0 mg/ml: >
240 Minutes | Fluorouracil 50.0 mg/ml: >
240 Minutes | Same |
| | Methotrexate 25.0
mg/ml(25,000 ppm): >240
Minutes | / | Different |
| | Paclitaxel 6.0 mg/ml: >240
Minutes | Paclitaxel (Taxol) 6.0
mg/ml:
240 Minutes | Same |
| | ThioTepa 10.0 mg/ml: 76.3
Minutes | Thio-Tepa 10.0 mg/ml:
White:16.9 Minutes;
Orange: 72.5 Minutes | Similar |
8.0 Summary of Non-Clinical Testing
Biocompatibility Testing
The biocompatibility evaluation for Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs) 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
8
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:
- 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 (Reapproved 2019), Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
| Test
| Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM | |||
| D6319 | Physical | ||
| Dimensions | |||
| Test | Length(mm): | ||
| XS: ≥220; | |||
| S/M/L/XL/XXL: ≥230; | |||
| Width(mm): | |||
| XS: 70±10; | |||
| S: 80±10; | |||
| M: 95±10; | |||
| L: 110±10; | |||
| XL: 120±10; | |||
| XXL: 130±10 | Length(mm): |
240/Pass;
Width(mm):
XS: 67-72/Pass
S: 76-83/Pass
M: 91-99/ Pass
L: 106-112/ Pass
XL:116-124/ Pass
XXL: 127-134/ Pass |
| | | Finger: ≥0.05;
Palm: ≥0.05 | Thickness (mm):
Finger: 0.06-0.10/Pass
Palm: 0.07-0.10/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