(267 days)
Not Found
No
The document describes a standard medical examination glove and its performance characteristics, with no mention of AI or ML technology.
No
The device is a patient examination glove, intended to prevent contamination between patient and examiner, not to provide therapy.
No
Explanation: The device is a patient examination glove used for preventing contamination, not for diagnosing medical conditions. Its described tests relate to physical properties and chemical resistance, not diagnostic capabilities.
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 testing, not software validation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states the device is a "patient examination glove" intended to be worn on the examiner's hand or fingers to prevent contamination between patient and examiner. It's a physical barrier device used during patient interaction.
- Lack of Specimen Analysis: There is no mention of the device being used to analyze any biological specimens.
- Performance Studies: The performance studies focus on the physical properties of the glove (strength, watertightness, resistance to chemicals) and biocompatibility, not on the analysis of biological samples.
The fact that the gloves are tested for use with chemotherapy drugs relates to their protective function as a barrier, not to their use in diagnosing or analyzing patient samples.
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.
- The following is the resistance to permeation by chemotherapy drugs for the blue gloves.
| Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes |
|---|---|---|
| Carboplatin | 10.0 mg/ml | > 240 Minutes |
| Carmustine | 3.3 mg/ml | 18.4 Minutes |
| Cisplatin | 1.0 mg/ml | > 240 Minutes |
| Cyclophosphamide | 20.0 mg/ml | > 240 Minutes |
| Doxorubicin HCI | 2.0 mg/ml | > 240 Minutes |
| Etoposide | 20.0 mg/ml | 202.7 Minutes |
| Fluorouracil | 50.0 mg/ml | > 240 Minutes |
| Paclitaxel | 6.0 mg/ml | > 240 Minutes |
| ThioTepa | 10.0 mg/ml | 26.6 Minutes |
Please note that the following drugs have low permeation times: Carmustine 3.3 mg/ml 18.4 Minutes ThioTepa 10.0 mg/ml 26.6 Minutes Etoposide 20.0 mg/ml 202.7 Minutes Warning: Please do not use with Carmustine, ThioTepa and Etoposide.
- The following is the resistance to permeation by chemotherapy drugs for the purple gloves.
| Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes |
|---|---|---|
| Carboplatin | 10.0 mg/ml | > 240 Minutes |
| Carmustine | 3.3 mg/ml | 20.9 Minutes |
| Cisplatin | 1.0 mg/ml | > 240 Minutes |
| Cyclophosphamide | 20.0 mg/ml | > 240 Minutes |
| Doxorubicin HCI | 2.0 mg/ml | > 240 Minutes |
| Etoposide | 20.0 mg/ml | > 240 Minutes |
| Fluorouracil | 50.0 mg/ml | > 240 Minutes |
| Paclitaxel | 6.0 mg/ml | > 240 Minutes |
| ThioTepa | 10.0 mg/ml | 33.5 Minutes |
Please note that the following drugs have low permeation times: Carmustine 3.3 mg/ml 20.9 Minutes ThioTepa 10.0 mg/ml 33.5 Minutes Warning: Please do not use with Carmustine and ThioTepa.
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/purple colored, nitrile, and tested for use with chemotherapy drugs. The gloves are offered in four sizes: S, M, L, XL. 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 / Not Found
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)
Study Type: Non-Clinical Testing
Sample Size: Not explicitly stated for all tests, but acceptance criteria and results are provided.
AUC: Not Applicable
MRMC: Not Applicable
Standalone Performance: Not Applicable
Key Results:
Biocompatibility Testing:
- Per ISO 10993-10: Not an irritant and not a sensitizer.
- Per ISO 10993-5: Device extract is cytotoxic.
- Per ISO 10993-11: Did not show acute systemic toxicity in vivo.
Performance Testing (Bench):
- ASTM D6319 (Physical Dimensions Test):
- Length (mm): S: ≥220; M/L/XL: ≥230. Results pass.
- Width (mm): S: 80±10; M: 95±10; L: 110±10; XL: 120±10. Results pass for both blue and purple gloves across sizes.
- Thickness (mm): Finger: ≥0.05; Palm: ≥0.05. Results pass for both blue and purple gloves.
- ASTM D5151 (Watertightness Test for Detection of Holes): Meets AQL 2.5 criteria. Result: 0/125/Pass.
- ASTM D6124 (Powder Content): Meets requirements of
§ 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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 20, 2022
Mezorrison Medical Technology (Dongying) Co., Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.1801,No.161 Lujiazui East Rd.,Pudong Shanghai. 200120 China
Re: K214056
Trade/Device Name: Disposable Nitrile Inspection 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: August 22, 2022 Received: August 23, 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.
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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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) K214056
Device Name
Disposable Nitrile Inspection 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.
- The following is the resistance to permeation by chemotherapy drugs for the blue gloves.
| Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes |
|---|---|---|
| Carboplatin | 10.0 mg/ml | > 240 Minutes |
| Carmustine | 3.3 mg/ml | 18.4 Minutes |
| Cisplatin | 1.0 mg/ml | > 240 Minutes |
| Cyclophosphamide | 20.0 mg/ml | > 240 Minutes |
| Doxorubicin HCI | 2.0 mg/ml | > 240 Minutes |
| Etoposide | 20.0 mg/ml | 202.7 Minutes |
| Fluorouracil | 50.0 mg/ml | > 240 Minutes |
| Paclitaxel | 6.0 mg/ml | > 240 Minutes |
| ThioTepa | 10.0 mg/ml | 26.6 Minutes |
Please note that the following drugs have low permeation times: Carmustine 3.3 mg/ml 18.4 Minutes ThioTepa 10.0 mg/ml 26.6 Minutes Etoposide 20.0 mg/ml 202.7 Minutes Warning: Please do not use with Carmustine, ThioTepa and Etoposide.
- The following is the resistance to permeation by chemotherapy drugs for the purple gloves.
| Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes |
|---|---|---|
| Carboplatin | 10.0 mg/ml | > 240 Minutes |
| Carmustine | 3.3 mg/ml | 20.9 Minutes |
| Cisplatin | 1.0 mg/ml | > 240 Minutes |
| Cyclophosphamide | 20.0 mg/ml | > 240 Minutes |
| Doxorubicin HCI | 2.0 mg/ml | > 240 Minutes |
| Etoposide | 20.0 mg/ml | > 240 Minutes |
| Fluorouracil | 50.0 mg/ml | > 240 Minutes |
| Paclitaxel | 6.0 mg/ml | > 240 Minutes |
| ThioTepa | 10.0 mg/ml | 33.5 Minutes |
Please note that the following drugs have low permeation times: Carmustine 3.3 mg/ml 20.9 Minutes ThioTepa 10.0 mg/ml 33.5 Minutes Warning: Please do not use with Carmustine and ThioTepa.
3
Type of Use (Select one or both, as applicable)
] Prescription Use (Part 21 CFR 801 Subpart D)
区 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."
4
510(k) Summary K214056
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter's Information
Name: Mezorrison Medical Technology (Dongying) Co., Ltd. Address: Room 202, No. 166 of East Campus, Nanyi Road, the Development Zone of Dongying, Shandong, China Contact: Ping Chen Date of Preparation: Aug.22, 2022
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 Inspection Gloves (Tested for Use with Chemotherapy Drugs) Patient Examination Gloves Common name: Classification name: Non-powdered patient examination glove Model(s): S, M, L, XL
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
5
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/purple colored, nitrile, and tested for use with chemotherapy drugs. The gloves are offered in four sizes: S, M, L, XL. 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 | > 240 |
| Carmustine | 3.3 mg/ml | 18.4 |
| Cisplatin | 1.0 mg/ml | > 240 |
| Cyclophosphamide | 20.0 mg/ml | > 240 |
| Doxorubicin HCI | 2.0 mg/ml | > 240 |
| Etoposide | 20.0 mg/ml | 202.7 |
| Fluorouracil | 50.0 mg/ml | > 240 |
| Paclitaxel | 6.0 mg/ml | > 240 |
| ThioTepa | 10.0 mg/ml | 26.6 |
6.1 The following is the resistance to permeation by chemotherapy drugs for the blue gloves.
Please note that the following drugs have low permeation times:
Carmustine (BCNU) 3.3 mg/ml 18.4 Minutes;
Thio Tepa 10.0 mg/ml 26.6 Minutes.
Etoposide 20.0 mg/ml 202.7 Minutes
Warning: Please do not use with Carmustine, ThioTepa and Etoposide.
6.2 The following is the resistance to permeation by chemotherapy drugs for the purple gloves.
6
| Chemotherapy Drug | Concentration | Breakthrough Detection
Time in Minutes |
|-------------------|---------------|-------------------------------------------|
| Carboplatin | 10.0 mg/ml | > 240 |
| Carmustine | 3.3 mg/ml | 20.9 |
| Cisplatin | 1.0 mg/ml | > 240 |
| Cyclophosphamide | 20.0 mg/ml | > 240 |
| Doxorubicin HCI | 2.0 mg/ml | > 240 |
| Etoposide | 20.0 mg/ml | > 240 |
| Fluorouracil | 50.0 mg/ml | > 240 |
| Paclitaxel | 6.0 mg/ml | > 240 |
| ThioTepa | 10.0 mg/ml | 33.5 |
Please note that the following drugs have low permeation times:
Carmustine (BCNU) 3.3 mg/ml 20.9 Minutes;
Thio Tepa 10.0 mg/ml 33.5 Minutes.
Warning: Please do not use with Carmustine (BCNU) and ThioTepa.
7.0 Technological Characteristic Comparison Table
| Item | Subject Device
(K214056) | 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 | 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 | Same |
Table1-General Comparison
7
| Powdered or Powered free | Chemotherapy Drugs. | Chemotherapy Drugs. | ||||
|---|---|---|---|---|---|---|
| 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: | |||||
| S:≥220; | ||||||
| M/L/XL: ≥230; | ||||||
| Width: | ||||||
| S: 80±10; | ||||||
| M: 95±10; | ||||||
| L: 110±10; | ||||||
| XL: 120±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 | |||||
| Analysis | ||||||
| 1 | ||||||
| Thickness(mm) | Finger: ≥0.05; | |||||
| Palm: ≥0.05 | Finger: ≥0.05; | |||||
| Palm: ≥0.05 | Same | |||||
| Colorant | Blue, Purple | White, Orange | Different | |||
| Analysis | ||||||
| 2 | ||||||
| Physical | ||||||
| Properties | Before | |||||
| Aging | Tensile | |||||
| Strength | 14MPa, | |||||
| min | Tensile | |||||
| Strength | 14MPa, | |||||
| min | Same | |||||
| Ultimate | ||||||
| Elongation | 500% min | Ultimate | ||||
| Elongation | 500% min | Same | ||||
| After Aging | Tensile | |||||
| Strength | 14MPa, | |||||
| min | Tensile | |||||
| Strength | 14MPa, | |||||
| min | Same | |||||
| Ultimate | ||||||
| Elongation | 400%min | Ultimate | ||||
| Elongation | 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 | Same | |||||
| Powder Content | 0.1~0.3 mg per glove, | |||||
| Meet the requirements | ||||||
| of ASTM D6124 | Meet the requirements | |||||
| of ASTM D6124 | Similar | |||||
| Analysis | ||||||
| 3 | ||||||
| Biocompatibility | ISO 10993-10; | |||||
| Under the conditions of | ||||||
| the study, not an irritant | ISO 10993-10; | |||||
| Under the conditions of | ||||||
| the study, not an irritant | Same |
8
| or a sensitizer | or a sensitizer | |||
|---|---|---|---|---|
| ISO 10993-5 | ||||
| Under conditions of the | ||||
| study, device extract is | ||||
| cytotoxic | ||||
| ISO 10993-11; | ||||
| Under the | ||||
| condition of acute | ||||
| systemic toxicity test, | ||||
| the test article did not | ||||
| show acute systemic | ||||
| toxicity in vivo. | ISO 10993-5 | |||
| Under conditions of the | ||||
| study, device extract is | ||||
| not cytotoxic | Different | |||
| Analysis 4 | ||||
| Carboplatin | ||||
| 10.0 mg/ml | >240 Minutes | / | Different | |
| Analysis 5 | ||||
| Carmustine | ||||
| 3.3 mg/ml | Blue: 18.4 Minutes | |||
| Purple: 20.9 Minutes | White:11.8 Minutes; | |||
| Orange:31.6Minutes | Similar | |||
| Cisplatin | ||||
| 1.0 mg/ml | >240 Minutes | >240 Minutes | Different | |
| Analysis 5 | ||||
| Chemotherapy | ||||
| Drugs Tested | ||||
| with Minimum | ||||
| Breakthrough | ||||
| Detection Time | ||||
| as Tested per | ||||
| ASTM D 6978 | Cyclophosph | |||
| -amide | ||||
| 20.0 mg/ml | >240 Minutes | >240 Minutes | Same | |
| Dacarbazine | ||||
| 10.0 mg/ml | / | >240 Minutes | Different | |
| Analysis 5 | ||||
| Doxorubicin | ||||
| HCI | ||||
| 2.0 mg/ml | >240 Minutes | >240 Minutes | Same | |
| Etoposide | ||||
| 20.0 mg/ml | Blue: 202.7 Minutes | |||
| Purple: >240 Minutes | >240 Minutes | Different | ||
| Analysis 5 | ||||
| Fluorouracil | ||||
| 50.0 mg/ml | >240 Minutes | >240 Minutes | Same | |
| Paclitaxel | ||||
| 6.0 mg/ml | >240 Minutes | >240 Minutes | Same | |
| ThioTepa | ||||
| 10.0 mg/ml | Blue: 26.6 Minutes | |||
| Purple: 33.5 Minutes | White:16.9 Minutes; | |||
| Orange: 72.5 Minutes | Different | |||
| Analysis 5 |
Analysis 1:
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.
Analysis 2:
The color of the subject device is different with that of the predicate. The subject device was evaluated according to ISO 10993-1 standards, and there were no risks identified.
9
Analysis 3:
Powder Content of subject device is similar with that of the predicate, because the predicate did not publish the exact results of the powder content. But they all meet the requirements of ASTM D6319-19, so the differences do not raise any new safety or performance questions.
Analysis 4:
Under conditions of the ISO 10993-5 study, subject device extract is cytotoxic, but under the condition of the acute systemic toxicity test, the test article did not show systemic toxicity in vivo. Under conditions of the study, predicate device extract is not cytotoxic. Both of the subject device and predicate device have passed the toxicity study, so it does not raise any new safety or performance questions.
Analysis 5:
And Breakthrough detection times of Carboplatin, Carmustine, Dacarbazine, Etoposide, and Thio Tepa of subject device are different with those of the predicate. The Chemotherapy Labeling Claims has clearly defined on the labeling. So it does not raise any new safety or performance questions.
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
ISO 10993-11:2017, 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 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
10
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:
- 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): | ||
| S: ≥220; | |||
| M/L/XL: ≥230. | Length(mm): | ||
| S: ≥220; | |||
| M/L/XL: ≥230. | |||
| Width(mm): | |||
| S: 80±10; | |||
| M: 95±10; | |||
| L: 110±10; | |||
| XL: 120±10. | Width(mm): | ||
| Blue: | |||
| S: 84-86/Pass | |||
| M: 96-98/ Pass | |||
| L: 104-106/Pass | |||
| XL:114-116/ Pass | |||
| Purple: | |||
| S: 88-90/Pass | |||
| M: 99-100/ Pass | |||
| L: 102-104/ Pass | |||
| XL:115-117/ Pass | |||
| Finger: ≥0.05; | |||
| Palm: ≥0.05 | Thickness (mm): | ||
| Finger: | |||
| Blue: | |||
| 0.10-0.13/Pass | |||
| Purple: | |||
| 0.12-0.15/Pass |
Table 2 - Summary of non-clinical performance testing
11
| Palm: | |||||
|---|---|---|---|---|---|
| Blue: | |||||
| 0.06-0.09/Pass | |||||
| Purple: | |||||
| 0.07-0.09/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 |