(99 days)
Not Found
No
The 510(k) summary describes a standard medical examination glove and its performance testing against established standards for physical properties and chemotherapy drug permeation. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device, examination gloves, is intended to prevent contamination between patient and examiner and to be used with chemotherapy drugs. It does not directly treat or alleviate a disease or condition in a patient.
No
The device is a medical glove, which is used to prevent contamination, not to diagnose a medical condition.
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 performance testing and permeation testing for chemotherapy drugs, which are characteristics of a hardware device, not software.
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 describes a barrier device used externally.
- Device Description: The description reinforces this, detailing a glove worn on the hands for contamination prevention.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment. This device does not interact with or analyze such specimens.
- Performance Studies: The performance studies focus on the physical properties of the glove (tensile strength, elongation, freedom from holes, powder content) and its resistance to chemotherapy drugs. These are relevant to the glove's function as a barrier, not to diagnostic testing.
The fact that the gloves are tested for use with chemotherapy drugs is a performance characteristic related to their barrier function in a specific medical context, not an indication that they are used for in vitro diagnostic purposes.
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.
Product codes (comma separated list FDA assigned to the subject device)
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 four sizes: small, medium, large, and extra-large.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner's hand or fingers to prevent contamination between patient and examiner.
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
- ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests for Irritation And Skin Sensitization.
- Purpose: This part of ISO 10993 assesses possible contact hazards from chemicals released from medical devices, which may produce skin and mucosal irritation, eye irritation or skin sensitization.
- Results: Skin Sensitization Test: All grades are 0. All animals were survived and no abnormal signs were observed during the study. Skin Irritation Test: The primary irritation index is 0. The response of the proposed device was categorized as negligible under the test condition.
- ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
- Purpose: This part of ISO 10993 describes test methods to assess the in vitro cytotoxicity of medical devices.
- Results: Viab.% of 100% test article extract is 21.0%. It means the proposed device have potential toxicity to L-929 in the MTT method.
- ISO 10993-11 Third edition 2017-09 Biological evaluation of medical devices -Part 11: Tests for systemic toxicity
- Purpose: To evaluate the potential for medical device materials to cause adverse systemic reactions.
- Results: There was no evidence of systemic toxicity from the extract.
Performance Testing (Bench)
- ASTM D6319-10, Standard Specification for Disposable Nitrile Powder-Free Examination Gloves for Medical Application: Physical performance qualities were evaluated.
- Key Results: Tensile strength before aging: 15.2-17.6 MPa; Ultimate Elongation before aging: 629.928% - 788.321%. Tensile strength after aging: 14.2-18.7MPa; Ultimate Elongation after aging: 601.793% - 738.384%. Dimensions and thickness also met specifications.
- ASTM D6978-05 (Reapproved 2019), Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs: Minimum breakthrough times were determined for a wide range of chemotherapy drugs.
- Key Results: Carmustine (BCNU) 3.3 mg/ml: 23.6 Minutes (min.); Cisplatin 1.0 mg/ml: > 240 Minutes; Cyclophosphamide (Cytoxan) 20.0 mg/ml: > 240 Minutes; Dacarbazine 10 mg/ml: > 240 Minutes; Doxorubicin HCl 2.0 mg/ml: > 240 Minutes; Etoposide 20.0 mg/ml: > 240 Minutes; Fluorouracil 50.0 mg/ml: >240 Minutes; Methotrexate, 25 mg/ml (25,000 ppm): >240 Minutes; Mitomycin C, 0.5 mg/ml (500 ppm): >240 Minutes; Paclitaxel 6.0 mg/ml: >240 Minutes; Thio Tepa 10.0 mg/ml: 37.4 Minutes (min.); Vincristine Sulfate, 1mg/ml (1,000 ppm): >240 Minutes.
- ASTM D6124-06 (Reapproved 2017), Standard Test Method for -Residual Powder on Medical Gloves
- Results: 0.09-0.11 mg /glove. (Acceptance criteria: powder residue limit of 2.0 mg)
- ASTM D5151-19, Standard Test Method for Detection of Holes in -Medical Gloves.
- Results: no glove water leakage found. (Acceptance criteria: Samples number: 125 gloves, AQL: 2.5 (ISO 2859), Criterion ≤7 gloves for water leakage)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Biocompatibility:
- Irritation: Not an irritant
- Sensitization: Not a sensitizer
- Cytotoxicity: Potentially cytotoxic (Viab.% of 100% test article extract is 21.0%)
- Systemic toxicity: Does not elicit a systemic toxicity response.
- Physical Properties (ASTM D6319-19):
- Before Aging: Tensile Strength 14MPa, min; Ultimate Elongation 500% min.
- After Aging: Tensile Strength 14MPa, min; Ultimate Elongation 400% min.
- Freedom from Holes (ASTMD5151): AQL=2.5
- Powder Content (ASTM D6124): 0.09-0.11 mg per glove
- Chemotherapy Drugs Breakthrough Time (ASTM D 6978-05):
- Carmustine (BCNU) 3.3 mg/ml: 23.6 Minutes
- Thio Tepa 10.0 mg/ml: 37.4 Minutes
- Other tested drugs: > 240 Minutes.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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" in a smaller font.
June 1, 2022
Anhui Zhong Lian Latex Gloves Manufacturing Co., Ltd. % Boyle Wang General Manager Shanghai Truthful Information Technology Co., Ltd. Room608,No.738,Shangcheng Rd.,Pudong Shanghai, Shanghai 200120 China
Re: K220488
Trade/Device Name: Disposable Nitrile Powder-Free 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: April 25, 2022 Received: May 2, 2022
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,
Bifeng Oian, M.D., Ph.D. Acting 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) K220488
Device Name
Disposable Nitrile Powder-Free 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) | 23.6 (23.6, 27.5, 25.2) Minutes |
| Cisplatin | 1.0 mg/ml(1,000 ppm) | > 240 Minutes |
| Cyclophosphamide (Cytoxan) | 20.0 mg/ml(20,000 ppm) | > 240 Minutes |
| Dacarbazine | 10 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 |
| Methotrexate | 25 mg/ml (25,000 ppm) | >240 Minutes |
| Mitomycin C | 0.5 mg/ml (500 ppm) | >240 Minutes |
| Paclitaxel | 6.0 mg/ml(6,000 ppm) | >240 Minutes |
| Thio Tepa | 10.0 mg/ml(10,000 ppm) | 37.4 (38.8, 37.4, 37.5) Minutes |
| Vincristine Sulfate | 1 mg/ml (1,000 ppm) | > 240 Minutes |
Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 23.6 Minutes (min.); Thio Tepa 10.0 mg/ml 37.4 Minutes (min.). Warning: Please do not use with Carmustine (BCNU) and Thiotena.
| 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)
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3
510(k) Summary
K220488
This summary of 510(k) K220488 is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter's Information
Name: ANHUI ZHONG LIAN LATEX GLOVES MANUFACTURING CO., LTD. Address: GUZHEN ECONOMIC DEVELOPMENT ZONE BENGBU CITY ANHUI CHINA GUZHEN ECONOMIC DEVELOPMENT ZONE BENGBU CITY Contact: ANHUI CHINA Date of Preparation: 2022.05.26
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 Powder-Free 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
3.0 Classification
Production code: LZA,LZC Requlation number: 21CFR880.6250 Classification: Class I Panel: General Hospital
4.0 Predicate Device Information
Ever Growth (Vietnam) Co., Ltd. Manufacturer: Disposable Powder Free Nitrile Examination Glove, Tested For Device:
4
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.
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
(minutes) |
|-------------------------------|------------------------|--------------------------------------------------------|
| Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 23.6
(23.6, 27.5, 25.2 ) |
| Cisplatin | 1.0 mg/ml(1,000 ppm) | > 240 |
| Cyclophosphamide
(Cytoxan) | 20.0 mg/ml(20,000 ppm) | > 240 |
| Dacarbazine | 10 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 |
| Methotrexate | 25 mg/ml (25,000 ppm) | > 240 |
| Mitomycin C | 0.5 mg/ml (500 ppm) | > 240 |
| Paclitaxel | 6.0 mg/ml(6,000 ppm) | > 240 |
| Thio Tepa | 10.0 mg/ml(10,000 ppm) | 37.4
(38.8, 37.4, 37.5) |
| Vincristine Sulfate | 1 mg/ml (1,000 ppm) | > 240 |
Please note that the following drugs have low permeation times:
Carmustine (BCNU) 3.3 mg/ml 23.6 Minutes (min.);
Thio Tepa 10.0 mg/ml 37.4 Minutes (min.).
Warning: Please do not use with Carmustine (BCNU) and Thiotepa.
5
7.0 Technological Characteristic Comparison Table
| Item | Subject Device
K220488 | Predicate Device
(K190860) | Remark |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Product Code | LZA,LZC | LZA,LZC | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| 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. | 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. | Similar |
Table1-General Comparison
Table2 Device Dimensions Comparison
| Predicate
| Device(K190860) | Designation | Size | Tolerance | ||||
|---|---|---|---|---|---|---|---|
| XS | S | M | L | XL |
6
| Length, mm | 230 | 230 | 230 | 230 | 230 | min | |
|---|---|---|---|---|---|---|---|
| Width, mm | 70 | 80 | 95 | 110 | 120 | ±10 | |
| Thickness, mm: | |||||||
| Finger | 0.05 | min | |||||
| Palm | 0.05 | min | |||||
| Subject Device | Designation | Size | Tolerance | ||||
| S | M | L | XL | ||||
| Length, mm | 220 | 230 | 230 | 230 | min | ||
| Width, mm | 80 | 95 | 110 | 120 | ±10 | ||
| Thickness, mm: | |||||||
| Finger | 0.05 | min | |||||
| Palm | 0.05 | min | |||||
| Remark | Different |
Analysis: The physical dimensions are different with that of the predicate, but they all meet the requirements of ASTM D6319-19,so the differences do not raise any new safety or performance questions.
| Item | Subject device
K220488 | Predicate device
(K190860) | Remark | | |
|-----------------------------------------------------------|----------------------------------------------------------|-----------------------------------------------------------------------------------|------------------------|---------------------------------------------------------------------------------------------------------|---------|
| Colorant | Blue | White, Orange | Different 1 | | |
| Physical
Properties | Before
Aging | Tensile
Strength | 14MPa, min | 14MPa, min | Same |
| | | Ultimate
Elongation | 500% min | 500% min | Same |
| | After
Aging | Tensile
Strength | 14MPa, min | 14MPa, min | Same |
| | | Ultimate
Elongation | 400%min | 400%min | Same |
| | Comply with ASTM D6319 | | Comply with ASTM D6319 | 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 | Same |
| Powder Content | | 0.09-0.11 mg per glove, Meet the requirements of ASTM D6124 | | Meet the requirements of ASTM D6124 | Same |
| Chemotherapy Drugs
Tested with Minimum
Breakthrough | | Carmustine (BCNU) 3.3 mg/ml:
23.6 Minutes (min.)
Cisplatin 1.0 mg/ml: > 240 | | Carmustine (BCNU) 3.3 mg/ml:
White:11.8 Minutes;
Orange:31.6Minutes
Cisplatin 1.0 mg/ml: > 240 | Similar |
| Detection Time as
Tested per ASTM D
6978 | Minutes | 240 Minutes | | | |
| | Cyclophosphamide (Cytoxan)
20.0 mg/ml: > 240 Minutes | Cyclophosphamide
(Cytoxan)
20.0 mg/ml: > 240
Minutes | Same | | |
| | Dacarbazine 10 mg/ml:> 240
Minutes | Dacarbazine (DTIC)
10.0 mg/ml:
240 Minutes | Same | | |
| | Doxorubicin HCl 2.0 mg/ml: >
240 Minutes | Doxorubicin
Hydrochloride 2.0
mg/ml: >240 Minutes | Similar | | |
| | Etoposide 20.0 mg/ml: > 240
Minutes | Etoposide (Toposar)
20.0
mg/ml: >240 Minutes | Similar | | |
| | Fluorouracil 50.0 mg/ml: >
240 Minutes | Fluorouracil 50.0
mg/ml: >240
Minutes | Same | | |
| | Methotrexate, 25 mg/ml
(25,000 ppm): >240 Minutes | / | | | |
| | Mitomycin C, 0.5 mg/ml (500
ppm): >240 Minutes | / | Different 2 | | |
| | Paclitaxel 6.0 mg/ml: >240
Minutes | Paclitaxel (Taxol) 6.0
mg/ml:
240 Minutes | Same | | |
| | Thio Tepa 10.0 mg/ml: 37.4
Minutes (min.) | Thio-Tepa 10.0 mg/ml:
White:16.9 Minutes;
Orange: 72.5 Minutes | Similar | | |
| | Vincristine Sulfate, 1mg/ml
(1,000 ppm): >240 Minutes | / | Different 2 | | |
Table3 Performance Comparison
7
Analysis:
Different 1: The color of the subject device is different of that of the predicate. Biocompatibility testing was successfully completed for the subject device,
demonstrating that any color differences do not affect the safety of the proposed device.
Different 2: The chemotherapy drug is different with that of the predicate, but they all meet the requirements of ASTM D6978-05(2019),so the differences do not raise any new safety or performance questions.
Table4 Safety Comparison
8
| Item | Proposed device | Predicated device | Remark | |
|---|---|---|---|---|
| Material | Nitrile | Nitrile | SAME | |
| Biocompatibility | Irritation | Under the conditions of the study, not an irritant | Comply with ISO10993-10 | SAME |
| Sensitization | Under conditions of the study, not a sensitizer. | |||
| Cytotoxicity | Under the conditions of the study, the device is potentially cytotoxic | Comply with ISO10993-5 | Analysis3 | |
| Systemic toxicity | Under the conditions of the study, the device does not elicit a systemic toxicity response in the model animal. | Complies with ISO 10993-11 Third edition 2017-09 | ||
| Label and Labeling | Meet FDA's Requirement | Meet FDA's Requirement | SAME |
Analysis3: The proposed device is potentially cytotoxic, but all proposed devices are conducted the systemic toxicity test, the test results show that the proposed device is safe.
8.0 Summary of Non-Clinical Testing
Biocompatibility Testing
biocompatibility evaluation for Disposable Nitrile The Powder-Free 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
ISO 10993-11 Third edition 2017-09 Biological evaluation of medical devices -Part 11: Tests for systemic toxicity
Performance Testing (Bench)
Physical performance qualities of the proposed device were evaluated per ASTM D6319-10, Standard Specification for Disposable Nitrile Powder-Free 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.
9
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 Disposable Nitrile -Powder-Free 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.
| No. | Name of the Test
Methodology / Standard | Purpose | Acceptance Criteria | Results |
|-----|--------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | ISO 10993-10:2010
Biological Evaluation Of
Medical Devices - Part
10: Tests For Irritation
And Skin Sensitization. | This part of ISO
10993 assesses
possible contact
hazards from
chemicals
released from
medical devices,
which may
produce skin and
mucosal irritation,
eye irritation or
skin sensitization. | Skin Sensitization Test:
provided
grades less than 1,
otherwise
sensitization. | All grades are 0.
All animals were survived and no
abnormal signs were observed
during the study. |
| 2 | | | Skin Irritation Test:
If the primary irritation
index is 0-0,4, the
response category is
Negligible.
0,5-1,9 means slight
2-4,9 means moderate
5-8 means severe | The primary irritation index is 0.
The response of the proposed
device was categorized as
negligible under the test
condition |
| 3 | ISO 10993-5:2009
Biological Evaluation Of
Medical Devices - Part
5: Tests For In Vitro
Cytotoxicity | This part of ISO
10993 describes
test methods to
assess the in vitro
cytotoxicity of
medical devices. | The viab.% of the
100% extract of the
test article is the final
result, and if viability is
reduced to 240 Minutes |
| | | | | Cyclophosphamide (Cytoxan) 20.0 mg/ml: > 240
Minutes |
| | | | | Dacarbazine 10 mg/ml :> 240 Minutes |
| | | | | Doxorubicin HCl 2.0 mg/ml: > 240 Minutes |
| | | | | Etoposide 20.0 mg/ml: > 240 Minutes |
13
| Fluorouracil 50.0 mg/ml: >240 Minutes | ||
|---|---|---|
| Methotrexate, 25 mg/ml (25,000 ppm): >240 Minutes | ||
| Mitomycin C, 0.5 mg/ml (500 ppm): >240 Minutes | ||
| Paclitaxel 6.0 mg/ml: >240 Minutes | ||
| Thio Tepa 10.0 mg/ml: 37.4 Minutes (min.) | ||
| Vincristine Sulfate, 1mg/ml (1,000 ppm): >240 Minutes |
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 Powder-Free 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.