(91 days)
Not Found
No
The document describes a medical glove and its physical and chemical properties, with no mention of AI or ML technology.
No.
The device is a patient examination glove, which is a barrier device for contamination prevention, not a therapeutic device that treats or cures a disease or condition.
No
The device is a medical glove, which is a barrier device for prevention of contamination, not a diagnostic tool. Its performance metrics relate to physical properties and chemical resistance, not diagnostic accuracy.
No
The device is a physical medical device (gloves) and does not involve any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: An In Vitro Diagnostic device is a medical device that is used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
- Intended Use: The intended use of this device 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 used on the body, not for testing samples from the body.
- Device Description: The description reinforces that it's a glove worn on the hands.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting biomarkers, or performing any diagnostic tests. The testing mentioned (ASTM D6978-05) is related to the glove's barrier properties against chemotherapy drugs, not diagnostic capabilities.
Therefore, this device falls under the category of a medical device, specifically a patient examination glove, but it is not an In Vitro Diagnostic device.
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 qloves 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
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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:
The biocompatibility evaluation for Nitrile 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: - Irritation (ISO 10993-10:2010): All grades are 0. The primary irritation index is 0. The response of the proposed device was categorized as negligible under the test condition.
- Sensitization (ISO 10993-10:2010): All animals were survived and no abnormal signs were observed during the study.
- Cytotoxicity (ISO 10993-5:2009): Viab.% of 100% test article extract is 86.5%. It means the proposed device has no potential toxicity to L-929 in the MTT method.
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.
Standards and Results:
- ASTM D6124-06 (Reapproved 2017), Standard Test Method for - Residual Powder on Medical Gloves: 0.1 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 (Sample number: 125 gloves, AQL: 2.5 (ISO 2859) Criterion $\leq$ 7 gloves for water leakage).
- ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application:
- Dimensions: Met specifications for XS, S, M, L, XL sizes in length and width. Finger and Palm thickness met minimum requirements.
- Physical Properties (Before Aging): Tensile strength 21.6-29.5 MPa (Acceptance criterion $\geq$ 14MPa), Ultimate Elongation 536% - 571% (Acceptance criterion $\geq$ 500%).
- Physical Properties (After Accelerated Aging): Tensile strength 24.1-31.0 MPa (Acceptance criterion $\geq$ 14MPa), Ultimate Elongation 479% - 519% (Acceptance criterion $\geq$ 400%).
- ASTM D6978-05 (Reapproved 2019), Standard Practice for -Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs: Breakthrough Detection Time in Minutes for various chemotherapy drugs, including Carmustine (BCNU) which had a low permeation time of 15.1 minutes and Thio Tepa with 32.8 minutes. Most other tested drugs had > 240 minutes.
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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 1, 2021
5R MED Instruments (CHENGDU) Co., Ltd. Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.1801, No.161 Lujiazui East Rd., Pudong Shanghai. 200120 China
Re: K212789
Trade/Device Name: Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC Dated: August 27, 2021 Received: September 1, 2021
Dear Boyle Wang:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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.
For Clarence W. Murray III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number K212789
Device Name
Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)
Indications for Use (Describe)
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs.
| Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes |
|---|---|---|
| Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 15.1(15.1, 16.4, 16.6) Minutes |
| Cisplatin | 1.0 mg/ml(1,000 ppm) | > 240 Minutes |
| Cyclophosphamide (Cytoxan) | 20.0 mg/ml(20,000 ppm) | > 240 Minutes |
| Carboplatin | 10.0 mg/ml(10,000 ppm) | > 240 Minutes |
| Doxorubicin HCl | 2.0 mg/ml(2,000 ppm) | > 240 Minutes |
| Etoposide | 20.0 mg/ml(20,000 ppm) | > 240 Minutes |
| Fluorouracil | 50.0 mg/ml(50,000 ppm) | >240 Minutes |
| Paclitaxel | 6.0 mg/ml(6,000 ppm) | >240 Minutes |
| Thio Tepa | 10.0 mg/ml(10,000 ppm) | 32.8 (48.6, 32.8, 46.1) Minutes |
Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 15.1 Minutes (min.); Thio Tepa 10.0 mg/ml 32.8 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)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
K212789
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter's Information
5R MED Instruments (CHENGDU) Co., Ltd. Name: Address: Building 9, Section 1, No.618 of West Kelin Road, Chengdu Cross-Straits Technology Industry Development Zone, Wenjiang District, Chengdu, Sichuan Province, 611130, China Mr. Pan Yuzhang Contact: Date of Preparation: 2021.08.12
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 Examination Gloves (Tested for Use with Chemotherapy Trade name: Drugs) Common name: Patient Examination Gloves Classification name: Non-powdered patient examination glove Model(s): XS, 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
4
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 qloves 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 |
|-------------------------------|------------------------|-------------------------------------------|
| Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 15.1
(15.1,16.4,16.6) |
| Carboplatin | 10.0 mg/ml(10,000 ppm) | > 240 |
| Cyclophosphamide
(Cytoxan) | 20.0 mg/ml(20,000 ppm) | > 240 |
| Cisplatin | 1.0 mg/ml(1,000 ppm) | > 240 |
| Doxorubicin HCI | 2.0 mg/ml(2,000 ppm) | > 240 |
| Etoposide | 20.0 mg/ml(20,000 ppm) | > 240 |
| Fluorouracil | 50.0 mg/ml(50,000 ppm) | > 240 |
| Paclitaxel | 6.0 mg/ml(6,000 ppm) | > 240 |
| Thio Tepa | 10.0 mg/ml(10,000 ppm) | 32.8
(48.6, 32.8, 46.1) |
Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 15.1 Minutes (min.); Thio Tepa 10.0 mg/ml 32.8 Minutes (min.).
Warning: Please do not use with Carmustine (BCNU) and Thiotepa.
7.0 Technological Characteristic Comparison Table
5
| Subject Device | Predicate Device | ||
|---|---|---|---|
| Item | K212789 | (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. | Similar |
Table1-General Comparison
| 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: |
Table2 Device Dimensions Comparison
6
| Finger | 0.05 | min | |||||
|---|---|---|---|---|---|---|---|
| Palm | 0.05 | min | |||||
| Designation | Size | ||||||
| XS | S | M | L | XL | Tolerance | ||
| Subject Device | Length, mm | 220 | 220 | 230 | 230 | 230 | min |
| Width, mm | 70 | 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 | 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 | | 0.1mg 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: 15.1 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 | Same | |
Table3 Performance Comparison
7
| Minutes | |||
|---|---|---|---|
| Carboplatin 10.0 mg/ml: > 240 | |||
| Minutes | Dacarbazine (DTIC) | ||
| 10.0 mg/ml: |
240 Minutes | Different 2 |
| | Doxorubicin HCI 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 |
| | Paclitaxel 6.0 mg/ml: >240
Minutes | Paclitaxel (Taxol) 6.0
mg/ml:
240 Minutes | Same |
| | Thio Tepa 10.0 mg/ml: 32.8
Minutes (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, 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 | ||||
|---|---|---|---|---|
| Item | Subject device | Predicated device (K190860) | Remark | |
| Material | Nitrile | Nitrile | Same | |
| Biocompatibility | Irritation (ISO 10993-10:2010 | |||
| Biological | ||||
| Evaluation of | ||||
| Medical Devices - | ||||
| Part 10: Tests For | ||||
| Irritation And Skin | ||||
| Sensitization) | Under the conditions of | |||
| the study, not | ||||
| an irritant | Comply with | |||
| ISO10993-10 | Same | |||
| Sensitization (ISO | ||||
| 10993-10:2010 | Under conditions of |
Table4 Safety Comparison
8
| Biological
Evaluation
of
Medical Devices -
Part 10: Tests For
Irritation And Skin
Sensitization) | the study, not a
sensitizer. | | |
|---------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Cytotoxicity (ISO
10993-5:2009
Biological
Evaluation
of
Medical Devices -
Part 5: Tests For In
Vitro Cytotoxicity) | Under
conditions of
the study, the
device extract
is not cytotoxic | Under
conditions of
the study, the
device extract
is not cytotoxic | Same |
| Test
Methodology /
Standard | Purpose | Acceptance Criteria | Results |
| 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.
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 | All grades are 0.
All animals were survived
and no abnormal signs were
observed during the study.
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 | 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 | |
| | | Carboplatin 10.0 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 | |
| | | Paclitaxel 6.0 mg/ml: > 240 Minutes | |
| | | Thio Tepa 10.0 mg/ml: 32.8 Minutes (min.) | |
8.0 Summary of Non-Clinical Testing
Biocompatibility Testing
The biocompatibility evaluation for Nitrile 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 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:
9
- 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.
10
11
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, Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)
12
is as safe, as effective, and performs as well as or better than the legally marketed predicated device under K190860.