(90 days)
Not Found
No
The 510(k) summary describes a standard medical examination glove and its performance characteristics based on physical and chemical testing. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device, a patient examination glove, is intended to prevent contamination between a patient and an examiner, not to treat a disease or condition.
No
Explanation: The device is described as a "patient examination glove" used to "prevent contamination between patient and examiner." Its function is protective, not diagnostic.
No
The device description clearly states it is a physical product (gloves) and details their material, manufacturing standards, and physical properties. There is no mention of software as the primary component or function.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Intended Use: The intended use of this device is clearly stated as a "patient examination glove... worn on the examiner's hand to prevent contamination between patient and examiner." This is a barrier device for protection, not a device used to analyze biological specimens.
- Device Description: The description focuses on the physical characteristics of the glove and its testing for chemotherapy drug permeation, which relates to its protective function.
- Performance Studies: The performance studies listed (Water Leak Test, Dimension, Physical Properties, Chemotherapy Drugs permeation, Skin irritation, etc.) are all related to the physical integrity and safety of the glove as a barrier, not to the analysis of biological samples.
The testing for chemotherapy drug permeation is a specific performance characteristic of the glove related to its protective function in certain medical settings, but it does not change its fundamental classification as a barrier device, not an IVD.
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 hand to prevent contamination between patient and examiner.
These gloves were tested for use with chemotherapy drugs per ASTM D6978-05 (2019)Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Tested chemotherapy drugs are as follows: Carmustine (BCNU) 3.3 mg/ml 65.3 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 Hydrochloride 2.0 mg/ml >240 minutes Etoposide (Toposar) 20.0 mg/ml >240 minutes Fluorouracil 50.0 mg/ml >240 minutes Paclitaxel (Taxol) 6.0 mg/ml >240 minutes Thiotepa 10.0 mg/ml 58.3minutes
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC, OPJ
Device Description
Power-Free Nitrile Examination Gloves(Tested for Use with Chemotherapy Drugs) are non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between a patient and an examiner. The gloves are powder-free, ambidextrous with beaded cuff, Blue/Blue violet colored nitrile gloves featuring an inner coating of colloidal oatmeal USP. The gloves are offered in four sizes, small, medium, large and extra-large.
The gloves are designed and manufactured in accordance with the ASTM D6319-10 standard and are tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019).
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
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)
Non clinical tests were conducted in accordance with the following standards to verify that the proposed device met all design specifications.
- ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for ● Medical Application
- ASTM D3767-03(2020), Practice for rubber-Measurement of Dimensions ●
- ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves .
- ASTM D6124-06(2017), Standard Test Method for Residual Powder on Medical . Gloves
- ASTM D573-04(2019), Standard Test Method for Rubber—Deterioration in an Air ● Oven
- ASTM D412-16, Standard Test Methods for Vulcanized Rubber and ● Thermoplastic Elastomers-Tension
- ASTM D6978-05(2019), Standard Practice for Assessment of Resistance of . Medical Gloves to Permeation by Chemotherapy Drugs
- ISO 10993-10: 2010 Biological Evaluation Of Medical Devices Part 10: Tests For ● Irritation And Skin Sensitization.
- ISO 10993-11:2017, Biological evaluation of medical devices Part11:Tests for . Systemic Toxicity
Key Results: All tests passed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Water Leak Test (ASTM D5151): The gloves shall be free from hole when tested in accordance with the method given in ASTM D5151. (pass)
- Dimension (ASTM D3767): The actual measured dimension of the gloves shall be meet the stated tolerance in Table 2 of the ASTM D 6319-19. (pass)
- Physical Properties (Tensile Strength, Ultimate Elongation) (Before aging ASTM D412, After aging ASTM D573): Before and after accelerated aging, the gloves shall conform to the physical requirements in the Table 3 of ASTM 6319-19. (pass)
- Residual Powder Content Powder amount (ASTM D6124): The powder residue content shall be not more than 2mg per gloves. (pass)
- Chemotherapy Drugs (ASTM D6978-05): Carmustine (BCNU) 3.3 mg/ml 65.3 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 Hydrochloride 2.0 mg/ml >240 minutes Etoposide (Toposar) 20.0 mg/ml >240 minutes Fluorouracil 50.0 mg/ml >240 minutes Paclitaxel (Taxol) 6.0 mg/ml >240 minutes Thiotepa 10.0 mg/ml 58.3minutes. (pass)
- Skin irritation (ISO 10993-10:2010): non-sensitizing. (pass)
- Skin Sensitization (ISO 10993-10:2010): non-irritating. (pass)
- Acute Systemic Toxicity (ISO 10993-11:2017): No acute system toxicity. (pass)
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 contains 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.
July 22, 2021
Guangdong Kingfa Sci. & Tech. Co., Ltd. Xiaoge Yu Manager No. 28 Delong Ave., Shijiao Town, Qingcheng District Qingyuan, Guangdong 511545 China
Re: K211220
Trade/Device Name: Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet 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, OPJ Dated: April 16, 2021 Received: April 23, 2021
Dear Xiaoge Yu:
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, 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 (if known) K211220
Device Name
Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs Nitrile Patient Examination Gloves Blue Violet 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 hand to prevent contamination between patient and examiner.
These gloves were tested for use with chemotherapy drugs per ASTM D6978-05 (2019)Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Tested chemotherapy drugs are as follows: Carmustine (BCNU) 3.3 mg/ml 65.3 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 Hydrochloride 2.0 mg/ml >240 minutes Etoposide (Toposar) 20.0 mg/ml >240 minutes Fluorouracil 50.0 mg/ml >240 minutes Paclitaxel (Taxol) 6.0 mg/ml >240 minutes Thiotepa 10.0 mg/ml 58.3minutes
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
510(k) Summary K211220
I. Submitter
GUANGDONG KINGFA SCI. & TECH.CO., LTD. No.28 Delong Ave., Shijiao Town, Qingcheng District, Qingyuan, Guangdong, China
Contact person: Xiaoge Yu Position: Manager Tel.: +86-13570952157 E-mail: yuxiaoge@kingfa.com.cn
Preparation date: April. 03, 2021
US Agent
Jeff Zhang Ucl-Reg Service Inc 602 Rockwood Rd Wilmington, DE US 19802 Phone: 516 2311209 Email: us-agent@glomed-info.com
II. Proposed Device
| Device Trade Name | Nitrile Patient Examination Gloves Blue Tested For Use With
Chemotherapy Drugs
Nitrile Patient Examination Gloves Blue Violet Tested For Use
With Chemotherapy Drugs |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common name: | Patient Examination Glove |
| Regulation Number: | 21 CFR 880.6250 |
| Regulatory Class: | Class I |
| Product code: | LZA, LZC,OPJ |
| Review Panel | General Hospital |
III. Predicate Devices
| 510(k) Number: | K192315 |
|---|---|
| Trade name: | Medline Green Ambidextrous Power-Free Nitrile Examination |
| Gloves With Colloidal Oatmeal USP (Tested For Use With | |
| Chemotherapy Drugs) | |
| Common name: | Patient Examination Glove |
4
Classification: Class I
Product Code: LZA. LZC.OPJ Manufacturer Medline Industries, Inc.
IV. Device description
Power-Free Nitrile Examination Gloves(Tested for Use with Chemotherapy Drugs) are non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between a patient and an examiner. The gloves are powder-free, ambidextrous with beaded cuff, Blue/Blue violet colored nitrile gloves featuring an inner coating of colloidal oatmeal USP. The gloves are offered in four sizes, small, medium, large and extra-large.
The gloves are designed and manufactured in accordance with the ASTM D6319-10 standard and are tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019).
V. Indication for 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 per ASTM D6978-05 (2019)Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Tested chemotherapy drugs are as follows: Carmustine (BCNU) 3.3 mg/ml 65.3 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 Hydrochloride 2.0 mg/ml >240 minutes Etoposide (Toposar) 20.0 mg/ml >240 minutes Fluorouracil 50.0 mg/ml >240 minutes Paclitaxel (Taxol) 6.0 mg/ml >240 minutes Thiotepa 10.0 mg/ml 58.3minutes
5
VI. Comparison of technological characteristics with the predicate devices Table 1 Comparison of Natural Rubber Surgical Gloves
| Item | Proposed device
(K211220) | Predicate device
(K192315) | Discussion |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| Product name | Nitrile Patient
Examination Gloves Blue
Tested For Use With
Chemotherapy Drugs
Nitrile Patient
Examination Gloves Blue
Violet Tested For Use
With Chemotherapy
Drugs | Medline Green
Ambidextrous
Powder-Free Nitrile
Examination
Gloves with Colloidal
Oatmeal USP (Tested
for use with
Chemotherapy Drugs) | - |
| Product Code | LZA, LZC,OPJ | LZA, LZC,OPJ | Same |
| Regulation No. | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Classification | Class I | Class I | Same |
| Powder free | Yes | Yes | Same |
| Indication for 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 and
Fentanyl Citrate as per
ASTM D6978-05
(Reapproved
2019) Standard Practice
for Assessment of
Medical Gloves of
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
and Fentanyl Citrate as
per ASTM D6978-05
(Reapproved
2013) Standard Practice
for Assessment of
Medical Gloves of
Permeation by
Chemotherapy Drugs | Similar* |
| Main Material | Powder-Free Nitrile | Powder-Free Nitrile | Same |
| Color | Blue, Blue violet | Blue | Similar* |
| Size | small, medium, large,
x-large | x-small, small, medium,
large, x-large | Similar* |
| Dimensions –
Length | Complies with ASTM
D6319-10
S (220mm min)
M (230mm min)
L (230mm min)
XL (230mm min) | Complies with ASTM
D6319-10
220mm min. | Similar* |
| Dimensions -
Width | Complies with ASTM
D6319-10
Small (80±10mm)
Medium (95±10mm)
Large (110±10mm)
X large (120±10mm) | Complies with ASTM
D6319-10
X-small - 70±10mm
Small - 80±10mm
Medium - 95±10mm
Large - 110±10mm
X-large - 120±10mm | Similar* |
| Dimensions –
Thickness | Complies with:
ASTM D6319-10
Palm: 0.05mm min
Finger: 0.11mm min | Complies with:
ASTM D6319-10
Palm - 0.05mm min.
Finger – 0.05mm min. | Similar* |
| Physical
Properties | Complies with:
ASTM D6319-10
minimum:
Tensile Strength:
Before Aging $≥$ 14 MPa,
min.
After Aging $≥$ 14 MPa,
min. | Complies with:
ASTM D6319-10
minimum:
Tensile Strength:
Before Aging $≥$ 14
MPa, min.
After Aging $≥$ 14 MPa,
min. | Same |
| | Elongation:
Before Aging 500%, min.
After Aging 400%, min. | Elongation:
Before Aging 500%,
min.
After Aging 400%, min. | Same |
| Freedom from
Holes | Complies with ASTM
D6319-10 and ASTM
D5151-06 G-1, AQL 1.5 | Complies with:
ASTM D6319-10 and
ASTM D5151-06 G-1,
AQL 1.5 | Same |
| Powder or
Powder-Free | Powder-Free | Powder-Free | Same |
| Residual
Powder | Complies with:
ASTM D6319-10
240
minutes
Cyclophosphamide
(Cytoxan) 20.0
mg/ml >240 minutes
Dacarbazine (DTIC)10.0
mg/ml >240 minutes
Doxorubicin
Hydrochloride 2.0
mg/ml >240 minutes
Etoposide (Toposar) 20.0
mg/ml >240 minutes
Fluorouracil 50.0
mg/ml >240 minutes
Paclitaxel (Taxol) 6.0
mg/ml >240 minutes
Thiotepa 10.0 mg/ml
58.3minutes | Carmustine (BCNU) 3.3
mg/ml 65.3 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
Hydrochloride 2.0
mg/ml >240 minutes
Etoposide (Toposar)
20.0 mg/ml >240
minutes
Fluorouracil 50.0
mg/ml >240 minutes
Paclitaxel (Taxol) 6.0
mg/ml >240 minutes
Thiotepa 10.0 mg/ml
58.3minutes
Other Drugs | Similar
The Tested
Chemother
apy Drugs
of
Predicate
device is
more than
Proposed
device |
6
7
8
*As above comparison, the difference in the dimensions and reference standard version of the subject and predicate device does not raise additional questions for safety and effectiveness of the device. The biocompatibility test and performance test of the subject devices have been performed on the final finished device. The test results shows pass the requirements.
VII. Non-Clinical Testing
Non clinical tests were conducted in accordance with following standards to verify that the proposed device met all design specifications.
- ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for ● Medical Application
- ASTM D3767-03(2020), Practice for rubber-Measurement of Dimensions ●
- ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves .
- ASTM D6124-06(2017), Standard Test Method for Residual Powder on Medical . Gloves
- ASTM D573-04(2019), Standard Test Method for Rubber—Deterioration in an Air ● Oven
- ASTM D412-16, Standard Test Methods for Vulcanized Rubber and ● Thermoplastic Elastomers-Tension
- ASTM D6978-05(2019), Standard Practice for Assessment of Resistance of . Medical Gloves to Permeation by Chemotherapy Drugs
- ISO 10993-10: 2010 Biological Evaluation Of Medical Devices Part 10: Tests For ● Irritation And Skin Sensitization.
- ISO 10993-11:2017, Biological evaluation of medical devices Part11:Tests for . Systemic Toxicity
| Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM D5151 | Water Leak Test | The gloves shall be free | |
| from hole when tested in | |||
| accordance with the | |||
| method given in ASTM | |||
| D5151. | pass | ||
| ASTM D3767 | Dimension | The actual measured | |
| dimension of the gloves | |||
| shall be meet the stated | |||
| tolerance in Table 2 of | |||
| the ASTM D 6319-19 | pass | ||
| Before aging ASTM | |||
| D412, | |||
| After aging ASTM | |||
| D573 | Physical Properties | ||
| Tensile Strength, | |||
| Ultimate Elongation | Before and after | ||
| accelerated aging, the | |||
| gloves shall conform to | |||
| the physical | |||
| requirements in the | pass |
9
| | | Table 3 of ASTM 6319-
19 | |
|-------------------|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| ASTM D6124 | Residual Powder
Content
Powder amount | The powder residue
content shall be not
more than 2mg per
gloves. | pass |
| ASTM D6978-05 | Chemotherapy
Drugs | Carmustine (BCNU) 3.3
mg/ml 65.3 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
Hydrochloride 2.0 mg/ml
240 minutes
Etoposide (Toposar)
20.0 mg/ml >240
minutes
Fluorouracil 50.0 mg/ml
240 minutes
Paclitaxel (Taxol) 6.0
mg/ml >240 minutes
Thiotepa 10.0 mg/ml
58.3minutes | pass |
| ISO 10993-10:2010 | Skin irritation | non-sensitizing | pass |
| ISO 10993-10:2010 | Skin Sensitization | non-irritating | pass |
| ISO 10993-11:2017 | Acute Systemic
Toxicity | No acute system toxicity | pass |
VIII. Clinical Testing
No clinical study is included in this submission.
IX. Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device.