(86 days)
Not Found
No
The device description and performance studies focus solely on the physical and chemical properties of examination gloves, with no mention of AI or ML technologies.
No
The device is a patient examination glove, intended to prevent contamination between patient and examiner, not to provide therapy or treatment.
No
The device is a medical glove, a physical barrier intended to prevent contamination between patient and examiner. It does not perform any diagnostic function.
No
The device is a physical product (gloves) and the summary describes physical and chemical performance testing, not software functionality.
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 materials of the glove, and its testing for chemotherapy drug permeation. This aligns with a protective barrier device.
- Performance Studies and Key Metrics: The performance studies and key metrics are related to the physical and chemical properties of the glove (biocompatibility, strength, freedom from holes, chemotherapy drug permeation). 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 is a medical glove intended for protection and contamination prevention, not for in vitro diagnostic testing.
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: extra-small, 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 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)
Biocompatibility Testing
biocompatibility evaluation for Disposable Nitrile Powder-Free The 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
Results:
- ISO 10993-10:2010 (Skin Sensitization Test): All grades are 0. All animals were survived and no abnormal signs were observed during the study.
- ISO 10993-10:2010 (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 (In Vitro Cytotoxicity): Viab.% of 100% test article extract is 17.1%. It means the proposed device have potential toxicity to L-929 in the MTT method.
- ISO 10993-11:2017 (Systemic Toxicity): There was no evidence of systemic toxicity from the extract.
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.
Standards and Results:
- ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves: 0.15-0.19 mg /glove (Acceptance criteria: powder residue limit of 2.0 mg)
- ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves: no glove water leakage found (Samples number: 125 gloves, AQL: 2.5 (ISO 2859), Criterion 240 minutes for other listed drugs).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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 a blue rectangle with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 27, 2022
Shandong Maida Medical Technology Co.,Ltd. % Boyle Wang General Manager Shanghai Truthful Information Technology Co., Ltd. Room608,No.738,Shangcheng Rd.,Pudong Shanghai, Shanghai 200120 China
Re: K221271
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 18, 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.
Clarence W. Murray, III, 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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221271
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) | 22.8(23.7, 22.8, 23.1) 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 | 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 |
| Thio Tepa | 10.0 mg/ml(10,000 ppm) | 46.8(48.2, 48.6, 46.8) Minutes |
Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 22.8 Minutes (min.); Thio Tepa 10.0 mg/ml 46.8 Minutes (min.). 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) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
K221271 510(k) Summary
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter's Information
Name: Shandong Maida Medical Technology Co.,Ltd. Address: Room 102, Eastern building, No.166, South 1st Road, Development zone, Dongying, Shandong, China Room 102, Eastern building, No.166, South 1st Road, Development Contact: zone, Dongying, Shandong, China Date of Preparation: 2022.04.25
Designated Submission Correspondent
Mr. Boyle Wanq 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: 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 |
|---|---|
| Regulation number: | 21CFR880.6250 |
| Classification: | Class I |
| Panel: | General Hospital |
4.0 Predicate Device Information
Manufacturer: Ever Growth (Vietnam) Co., Ltd.
Disposable Powder Free Nitrile Examination Glove, Tested For Device: 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
4
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: extra-small, 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) | 22.8(23.7, 22.8, 23.1) |
| 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 | 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 |
| Thio Tepa | 10.0 mg/ml(10,000 ppm) | 46.8(48.2, 48.6, 46.8) |
Please note that the following drugs have low permeation times:
Carmustine (BCNU) 3.3 mg/ml 22.8 Minutes (min.);
Thio Tepa 10.0 mg/ml 46.8 Minutes (min.).
Warning: Please do not use with Carmustine (BCNU) and Thiotepa.
7.0 Technological Characteristic Comparison Table
| Item | Subject Device
Pending | Predicate Device
(K190860) | Comparison |
|----------------|---------------------------|-------------------------------|------------|
| Product Code | LZA,LZC | LZA,LZC | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
Table1-General Comparison
5
| 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 | 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 | Same |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| | Medical gloves to
Permeation
by
Chemotherapy Drugs. | Medical gloves to
Permeation
by
Chemotherapy Drugs. | |
| 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 |
Table2 Device Dimensions Comparison
| Predicate
| Device(K190860) | Designation | Size | Tolerance | ||||
|---|---|---|---|---|---|---|---|
| XS | S | M | L | XL | |||
| 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 |
6
| 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.
| Item | Subject device | Predicate device
(K190860) | Comparison | |
|-------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|-------------------------------|------------------------------------------------------------------------------|---------|
| Colorant | Blue | White, Orange | Different 1 | |
| Physical
Properties | Before Aging
Tensile Strength | 14MPa, min | 14MPa, min | Same |
| | Before Aging
Ultimate Elongation | 500% min | 500% min | Same |
| | After Aging
Tensile Strength | 14MPa, min | 14MPa, min | Same |
| | After Aging
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 | 0.15-0.19 mg per glove, Meet the requirements of ASTM D6124 | | Meet the requirements of ASTM D6124 | Same |
| Chemotherapy Drugs
Tested with Minimum
Breakthrough
Detection Time as
Tested per ASTM D
6978 | Carmustine (BCNU) 3.3 mg/ml:
22.8 Minutes (min.) | | Carmustine (BCNU)
3.3 mg/ml:
White:11.8 Minutes;
Orange:31.6Minutes | Similar |
| | Cisplatin 1.0 mg/ml: > 240 Minutes | | Cisplatin 1.0 mg/ml: > 240 Minutes | Same |
| | 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 |
Table3 Performance Comparison
7
| | Doxorubicin 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 |
| | Paclitaxel 6.0 mg/ml: >240
Minutes | Paclitaxel (Taxol) 6.0
mg/ml:
240 Minutes | Same |
| | Thio Tepa 10.0 mg/ml:
46.8Minutes (min.) | Thio-Tepa 10.0 mg/ml:
White:16.9 Minutes;
Orange: 72.5 Minutes | Similar |
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.
Table4 Safety Comparison
| Item | Proposed device | Predicated device | Comparison | |
|---|---|---|---|---|
| Material | Nitrile | Nitrile | SAME | |
| Biocompati | ||||
| bility | 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.
8
8.0 Summary of Non-Clinical Testing
Biocompatibility Testing
biocompatibility evaluation for Disposable Nitrile Powder-Free The 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.
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 D6978-05 (Reapproved 2019) ,Standard Practice for -Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
9
| 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, | 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 | | which may
produce skin and
mucosal irritation,
eye irritation or
skin sensitization. | 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 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 | |
| | | | Thio Tepa 10.0 mg/ml: 46.8Minutes (min.) | |
9.0 _Summary of Clinical Testing
Clinical testing is not needed for this device.
13
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.