(19 days)
Not Found
No
The 510(k) summary describes a standard medical examination glove and the performance testing relates to physical properties and resistance to chemotherapy drugs, with no mention of AI or ML.
No.
The device, a patient examination glove, is intended to prevent contamination between the patient and examiner, not to treat or cure a disease or condition.
No
Explanation: The device is a patient examination glove, intended to prevent contamination. Its function is not to diagnose any condition or disease.
No
The device description clearly states it is a physical, disposable glove made of nitrile, intended to be worn on the hands. It undergoes physical performance testing and permeation testing, which are characteristic of hardware devices, 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 purposes that is worn on the examiner's hands to prevent contamination between patient and examiner." This describes a barrier device used for protection, not a device used to perform tests on samples taken from the human body.
- Device Description: The description reinforces the intended use as a protective glove.
- 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 all characteristics relevant to a protective barrier, not an IVD.
- Key Metrics: The key metrics measured (Breakthrough Detection Time, Tensile Strength, etc.) are related to the glove's barrier function and physical integrity, not diagnostic measurements.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This glove does not perform any such function.
N/A
Intended Use / Indications for Use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
These gloves were tested for use with chemotherapy drugs, as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Product codes
LZA, LZC
Device Description
The subject device is single use, disposable gloves intended for medical purposes to be worn on the examiner's hands to prevent contamination between patient and examiner. The gloves are powder-free, ambidextrous with beaded cuff, blue colored, nitrile, and tested for use with chemotherapy drugs. The gloves are offered in five 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
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner / medical purposes
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The biocompatibility evaluation for Disposable Nitrile Medical Examination Glove(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:
- 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 D 6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
Key Results:
ASTM D6319 (Physical Dimensions Test)
- Length: > 230 mm (XS/S:>=220; M/L/XL: >=230) - Pass
- Width:
- XS: 72-74 mm (70+/-10) - Pass
- S: 80-83 mm (80+/-10) - Pass
- M: 95-98 mm (95+/-10) - Pass
- L: 110-114 mm (110+/-10) - Pass
- XL: 118-121 mm (120+/-10) - Pass
- Thickness:
- XS: Finger: 0.07-0.10 mm, Palm: 0.08-0.10 mm (Finger: >=0.05, Palm: >=0.05) - Pass
- S: Finger: 0.08-0.11 mm, Palm: 0.08-0.11 mm (Finger: >=0.05, Palm: >=0.05) - Pass
- M: Finger: 0.08-0.12 mm, Palm: 0.07-0.11 mm (Finger: >=0.05, Palm: >=0.05) - Pass
- L: Finger: 0.08-0.12 mm, Palm: 0.08-0.11 mm (Finger: >=0.05, Palm: >=0.05) - Pass
- XL: Finger: 0.08-0.12 mm, Palm: 0.08-0.12 mm (Finger: >=0.05, Palm: >=0.05) - Pass
ASTM D5151 (Watertightness Test for Detection of Holes)
- XS: 2/125 leaks
- S: 0/125 leaks
- M: 0/125 leaks
- L: 1/125 leaks
- XL: 0/125 leaks
- Meet the requirements of ASTM D5151 AQL 2.5 - Pass
ASTM D6124 (Powder Content)
- XS: 0.05mg
- S: 0.06mg
- M: 0.06mg
- L: 0.07mg
- XL: 0.09mg
- Meet the requirements of ASTM D6124 =14MPa) - Pass
- S: 15.3-16.9 MPa (>=14MPa) - Pass
- M: 15.4-17.3 MPa (>=14MPa) - Pass
- L: 15.4-17.6 MPa (>=14MPa) - Pass
- XL: 15.3-17.1 MPa (>=14MPa) - Pass
- Ultimate Elongation:
- XS: 524-569% (>=500%) - Pass
- S: 525-568% (>=500%) - Pass
- M: 525-567% (>=500%) - Pass
- L: 527-566% (>=500%) - Pass
- XL: 520-570% (>=500%) - Pass
After Aging
- Tensile Strength:
- XS: 15.3-17.0 MPa (>=14MPa) - Pass
- S: 15.4-16.9 MPa (>=14MPa) - Pass
- M: 15.4-16.4 MPa (>=14MPa) - Pass
- L: 15.3-16.6 MPa (>=14MPa) - Pass
- XL: 15.2-17.2 MPa (>=14MPa) - Pass
- Ultimate Elongation:
- XS: 526-568% (>=400%) - Pass
- S: 522-570% (>=400%) - Pass
- M: 527-570% (>=400%) - Pass
- L: 521-567% (>=400%) - Pass
- XL: 528-565% (>=400%) - Pass
ASTM D6978 (Chemotherapy Drugs Tested with Minimum Breakthrough Detection Time)
- Carmustine (BCNU) 3.3 mg/ml: 22.0 Minutes
- Cisplatin 1.0 mg/ml: > 240 Minutes
- Cyclophosphamide (Cytoxan) 20.0 mg/ml: > 240 Minutes
- Dacarbazine (DTIC) 10.0 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
- Methotrexate 25 mg/ml: >240 Minutes
- Mitomycin C 0.5 mg/ml: > 240 Minutes
- Paclitaxel 6.0 mg/ml: > 240 Minutes
- Thio Tepa 10.0 mg/ml: 59.2 Minutes
- Vincristine Sulfate 1.0 mg/ml: > 240 Minutes
Note: Carmustine (BCNU) 3.3 mg/ml: 22.0 Minutes and Thio Tepa 10.0 mg/ml: 59.2 Minutes have low permeation times.
Caution: Testing showed an average breakthrough time of 59.2 minutes with Thio-Tepa
WARNING: Do not use with Carmustine.
ISO 10993-5 (Cytotoxicity)
- Under conditions of the study, did not show potential toxicity to L-929 cells. - Pass
ISO 10993-10 (Irritation)
- Under conditions of the study, not an irritant. - Pass
ISO 10993-10 (Sensitization)
- Under conditions of the study, not a sensitizer. - Pass
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
September 20, 2022
Inner Mongolia Cureguard Medical Technology Co.,Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.1801,No.161, East Lujiazui Rd.,Pudong Shanghai, 200120 China
Re: K222642
Trade/Device Name: Disposable Nitrile Examination Glove (Tested for use with Chemotherapy Drug) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC Dated: September 1, 2022 Received: September 1, 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 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 Qian, 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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K22642
Device Name
Disposable Nitrile Examination Glove(Tested for Use with Chemotherapy Drugs)
Indications for Use (Describe)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
These gloves were tested for use with chemotherapy drugs, as per ASTM D6978-05 (Reapproved 2019) 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) | 22.0 Minutes |
| Cisplatin | 1.0 mg/ml(1,000 ppm) | > 240 Minutes |
| Cyclophosphamide (Cytoxan) | 20.0 mg/ml(20,000 ppm) | > 240 Minutes |
| Dacarbazine (DTIC) | 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 |
| 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) | 59.2 Minutes |
| Vincristine Sulfate | 1.0 mg/ml(1,000 ppm) | > 240 Minutes |
Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 22.0 Minutes Thio-Tepa 10.0 mg/ml 59.2 Minutes
Caution: Testing showed an average breakthrough time of 59.2 minutes with Thio-Tepa WARNING: Do not use with Carmustine
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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4
K222642 510(k) Summary
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter's Information
| Name: | Inner Mongolia Cureguard Medical Technology Co.,Ltd. | ||
|---|---|---|---|
| Address: | Room 326, Management Committee of New Industrial Park, | ||
| Tumote youqi, Baotou, Inner Mongolia Autonomous Region | |||
| 014100, China. | |||
| Contact: | Guo Hua | ||
| Tel: | +86-13485097856 |
Designated Submission Correspondent
| Contact: | Mr. Boyle Wang |
|---|---|
| Address: | Shanghai Truthful Information Technology Co., Ltd. |
| Room 1801, No.161 East Lu Jiazui Rd., Pudong,Shanghai | |
| 200120 China | |
| Tel: | +86-21-50313932 |
| Email: | info@truthful.com.cn |
Date submitted: Aug.9,2022
2.0 Device Information
| Trade name: | Disposable Nitrile Examination Glove (Tested for Use with
Chemotherapy Drugs) |
|----------------------|----------------------------------------------------------------------------------|
| Common name: | Patient Examination Gloves |
| Classification name: | Non-powdered patient examination glove |
| Model(s): | XS, S, M, L, XL |
| Production code: | LZA,LZC |
| Regulation number: | 21CFR880.6250 |
| Classification: | Class I |
| Panel: | General Hospital |
3.0 Predicate Device Information
| Manufacturer: | Medline Industries, Inc. |
|---|---|
| Device: | Medline Powder-Free Light Blue Nitrile Exam Glove (Tested for |
| Use with Chemotherapy Drugs) | |
| 510(k) number: | K201390 |
5
4.0 Indication for Use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
These gloves were tested for use with chemotherapy drugs, per ASTM D6978-05 Standard Practice for Assessment of Resistance 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) | 22.0 |
| Cisplatin | 1.0 mg/ml(1,000 ppm) | > 240 |
| Cyclophosphamide
(Cytoxan) | 20.0 mg/ml(20,000 ppm) | > 240 |
| Dacarbazine (DTIC) | 10.0 mg/ml(10,000 ppm) | > 240 |
| Doxorubicin HCl | 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) | 59.2 |
| Vincristine Sulfate | 1.0 mg/ml(1,000 ppm) | > 240 |
Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mq/ml 22.0 Minutes;
Thio Tepa 10.0 mg/ml 59.2 Minutes.
Caution: Testing showed an average breakthrough time of 59.2 minutes with Thio-Tepa
WARNING: Do not use with Carmustine.
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 five sizes: extra-small, small, medium, large, and extra-large.
6.0 Technological Characteristic Comparison Table
| Item | Subject Device | Predicated Device | Remark |
|---|---|---|---|
| ------ | ---------------- | ------------------- | -------- |
6
| (K201390) | |||
|---|---|---|---|
| Product Code | LZA,LZC | LZA,LZC | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| Intended Use | A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs as per ASTM D6978-05(2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. | A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs as per ASTM D6978-05(2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. | Same |
| Powdered or | |||
| Powered free | Powdered free | Powdered free | Same |
| Design Feature | Ambidextrous | Ambidextrous | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Labeling | |||
| Information | Single-use indication, powder free, device color, device name, glove size and quantity, Non-Sterile, a statement of standard ASTM D6978-05 compliance and a summary of the testing results | Single-use indication, powder free, device color, device name, glove size and quantity, Non-Sterile, a statement of standard ASTM D6978-05 compliance and a summary of the testing results | Same |
Table2 Device Dimensions Comparison
| Predicate
| Device(K201390) | Designation | Size | Tolerance | ||||
|---|---|---|---|---|---|---|---|
| XS | S | M | L | XL | |||
| Length, mm | NA | 240 | 240 | 240 | 240 | min | |
| Width, mm | NA | 85 | 95 | 105 | 115 | ±10 | |
| Thickness, mm: | |||||||
| Finger | 0.16 | min |
7
| Palm | 0.14 | min | |||||
|---|---|---|---|---|---|---|---|
| Designation | Size | ||||||
| Subject Device | XS | S | M | L | XL | Tolerance | |
| 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 | Predicated device
(K201390) | Remark | | |
|--------------------------|---------------------------------------------------------------------------|----------------------------------------------|---------------------------------------------------------------------------------|------------|-----------|
| Colorant | Blue | Light Blue | Different | | |
| Physical
Properties | Before
Aging | Tensile
Strength | 14Mpa, min | 17Mpa, min | Different |
| | | 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 | Meet the requirements of
ASTM D6124 240
Minutes | Cisplatin 1.0 mg/ml:
≥240
Minutes | Same | | |
| | Cyclophosphamide
(Cytoxan) 20.0 mg/ml: > | Cyclophosphamide
(Cytoxan) | Same | | |
Table3 Performance Comparison
8
| Chemotherapy
Drugs
Tested
with
Minimum
Breakthrough
Detection Time as
Tested per ASTM D
6978 | 240 Minutes | 20.0 mg/ml: ≥240
Minutes | |
|----------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|-------------------------------------------------------------|-----------|
| | Dacarbazine (DTIC) 10.0
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 | Same |
| | Etoposide 20.0 mg/ml: >
240 Minutes | Etoposide (Toposar)
20.0
mg/ml: ≥240 Minutes | Same |
| | Fluorouracil 50.0 mg/ml: >
240 Minutes | Fluorouracil 50.0
mg/ml: ≥240
Minutes | Same |
| | Methotrexate 25 mg/ml: >
240 Minutes | Methotrexate 25
mg/ml: ≥240
Minutes | Same |
| | Mitomycin C 0.5 mg/ml: >
240 Minutes | Mitomycin C 0.5
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: 59.2
Minutes | Thio-Tepa 10.0
mg/ml: 43.7
Minutes | Different |
| | Vincristine Sulfate 1.0
mg/ml: > 240 Minutes | Vincristine Sulfate
(Oncovin) 1.0
mg/ml: ≥240 Minutes | Same |
Table4 Safety Comparison
| Item | Subject
device | Predicated
device
(K201390) | Remark |
|-----------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|-----------------------------------|--------|
| Material | Nitrile | Nitrile | Same |
| 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 | | | |
9
| Biocompatibility | 10993-10:2010
Biological
Evaluation of
Medical Devices –
Part 10: Tests For
Irritation And Skin
Sensitization) | conditions of
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,
device extract
is not
cytotoxic | Under
conditions of
the study,
device
extract is
cytotoxic | Different |
| | Acute Systemic
Toxicity(ISO
10993-
11:2017,Biological
evaluation of
medical devices -
Part 11: Tests for
systemic toxicity) | N/A | Under
conditions of
the study,
device
extract is
non-toxic | Different |
8.0 Summary of Non-clinical Testing
The biocompatibility evaluation for Disposable Nitrile Medical Examination Glove(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
10
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 D 6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
| Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM D6319 | Physical | ||
| Dimensions | |||
| Test | Length(mm): | ||
| XS/S:≥220; | |||
| M/L/XL: ≥230; | Length: > 230 | ||
| Width(mm): | Width: | ||
| XS: 70±10; | XS: 72-74; | ||
| S: 80±10; | S: 80-83 | ||
| M: 95±10; | M: 95-98 | ||
| L: 110±10; | L: 110-114 | ||
| XL: 120±10 | XL: 118-121 | ||
| Pass | |||
| Thickness (mm) : | |||
| XS: | |||
| Finger: 0.07-0.10 | |||
| Palm: 0.08-0.10 | |||
| Finger: ≥0.05 | |||
| Palm: ≥0.05 | S: | ||
| Finger: 0.08-0.11 | |||
| Palm: 0.08-0.11 | |||
| M: | |||
| Finger: 0.08-0.12 | |||
| Palm: 0.07-0.11 | |||
| L: |
Table 5: Summary of Non-clinical Testing Table
11
| | | | | | Finger: 0.08-0.12
Palm: 0.08-0.11
XL:
Finger: 0.08-0.12
Palm: 0.08-0.12 |
|---------------|-----------------------------------------------------|-----------------------------------------------------------------------------------|------------------------------------------------|--------|----------------------------------------------------------------------------------------------------|
| | | | | | Pass |
| ASTM D5151 | Watertightness
Test for
Detection of
Holes | | Meet the requirements of
ASTM D5151 AQL 2.5 | | XS:2/125 leaks
S:0/125 leaks
M:0/125 leaks
L: 1/125 leaks
XL: 0/125 leaks |
| | | | | | |
| | | | | | Pass |
| ASTM D6124 | Powder Content | Meet the requirements of
ASTM D6124 240 Minutes |
| | | | | | Cyclophosphamide (Cytoxan) 20.0 mg/ml: > 240 Minutes |
| | | | | | Dacarbazine (DTIC) 10.0 mg/ml: > 240 Minutes |
| ASTM
D6978 | | | | | Doxorubicin HCI 2.0 mg/ml: > 240 Minutes |
| | | | | | Etoposide 20.0 mg/ml: > 240 Minutes |
| | | | | | Fluorouracil 50.0 mg/ml: >240 Minutes |
| | | | | | Methotrexate 25 mg/ml: >240 Minutes |
| | | | | | Mitomycin C 0.5 mg/ml: > 240 Minutes |
| | | | | | Paclitaxel 6.0 mg/ml: > 240 Minutes |
| | | | | | Thio Tepa 10.0 mg/ml: 59.2 Minutes |
| | | | | | Vincristine Sulfate 1.0 mg/ml: > 240 Minutes |
| ISO 10993-5 | Cytotoxicity | Non-cytotoxic | | | Under conditions of
the study, did not
show potential
toxicity to L-929
cells.
Pass |
| ISO 10993-10 | Irritation | Non-irritating | | | Under conditions of
the study, not an
irritant.
Pass |
| ISO 10993-10 | Sensitization | Non-sensitizing | | | Under conditions of
the study, not a
sensitizer.
Pass |
12
9.0 _Summary of Clinical Testing
13
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 Examination Glove (Tested for Use with Chemotherapy Drugs), is as safe, as effective, and performs as well as or better than the legally marketed predicate device under K201390.