Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a disposable examination glove and the description focuses on material properties and performance standards, with no mention of AI or ML.

Therapeutic

No
The device is described as a medical glove intended for preventing contamination, not for treating a disease or condition.

Diagnostic

No

The device description indicates it is a medical glove intended to prevent contamination, which is a barrier function, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device is a physical glove, not software. The description details physical properties and performance standards related to a tangible product.

IVD (In Vitro Diagnostic)

No, 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 the Nitrile Powder Free Examination Gloves Biodegradable (Green) is clearly stated as a "disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between examiner and patient." This is a barrier device used for protection, not for performing diagnostic tests on samples.
Device Description: The description focuses on the physical properties and standards met by the gloves, not on any diagnostic capabilities.
Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information.

The device is a medical glove, which is a type of medical device, but it falls under a different category than IVDs.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Nitrile Powder Free Examination Gloves Biodegradable (Green) is a medical glove which is a disposable device intended for medical purposes that is worn on the examiner’s hand or finger to prevent contamination between examiner and patient.

Product codes (comma separated list FDA assigned to the subject device)

LZA

Device Description

Nitrile Powder Free Examination Gloves Biodegradable (Green) meet all the requirements of ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application. The gloves are single use, disposable, and non-sterile. The gloves are offered in five sizes: S, M, L, XL, XXL.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

hand or finger

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)

Non-clinical tests were conducted to demonstrate that the proposed device met all design specifications. The test results demonstrated that the proposed device met the performance criteria with the following standards:

ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application
. ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves
ASTM D5511-18 Standard Test Method for Determining Anaerobic Biodegradation of Plastic . Materials Under High-Solids Anaerobic-Digestion Condition
. ASTM D6124-06(2022) Standard Test Method for Residual Powder on Medical Gloves
ISO 2859 Sampling Procedures and Tables for Inspection by Attributes
. ISO 10993-5 Biological evaluation of medical devices-Part 5 Tests for in vitro cytotoxicity
. ISO 10993-10:2021 Biological evaluation of medical devices Part 10: Tests for skin sensitization
ISO 10993-23:2021 Biological evaluation of medical devices Part 23: Tests for irritation ●
ISO 10993-11:2017 Biological evaluation of medical devices Part 11: Tests for systemic toxicity .

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

ASTM D6319-19:
- Length of the gloves: Min 230 for all sizes. Results: S – 246, M – 246, L – 246, XL - 250, XXL - 254.
- Width of the gloves: S – 80±10mm, M – 95±10mm, L – 105 ± 5mm, XL - 115 ± 5mm, XXL - > 120 mm. Results: S – 86, M – 99, L – 106, XL - 115, XXL - 125.
- Thickness of the gloves: palm and finger- Min 0.05mm. Results: S Palm 0.13 Finger 0.19, M Palm 0.13 Finger 0.19, L Palm 0.13 Finger 0.18, XL Palm 0.13 Finger 0.17, XXL Palm 0.12 Finger 0.19.
- Physical properties – Tensile Strength: Before Aging – Min 14 MPa, After Aging - Min 14 MPa. Results (M size): Before Aging 29.95, After Aging 29.66.
- Physical properties - Ultimate Elongation: Before Aging - Min.500, After Aging - Min. 400. Results (M size): Before Aging 561, After Aging 496.
ASTM D5151-19: Holes in the gloves - AQL 1.5. Results: S – Pass AQL 1.5, M – Pass AQL 1.5, L – Pass AQL 1.5, XL – Pass AQL 1.5, XXL – Pass AQL 1.5.
ASTM D6124-06(2022): Residual powder on the gloves - Max - 2 mg/glove. Result: 0.36mg.
ASTM D5511-18: Anaerobic biodegradation of plastic materials - Tested. Result: Adjusted Percent Biodegraded (%) – 7.2.
ISO 10993-5: In vitro cytotoxicity. Result: mild cytotoxicity reactivity result (2) with the neat extract (100%).
ISO 10993-10:2021: Skin sensitization. Result: extracts are not sensitizing to the animal model.
ISO 10993-23:2021: Irritation. Result: non-irritating extracts are not irritating to the animal model.
ISO 10993-11:2017: Systemic toxicity. Result: did not demonstrate any acute toxic reaction.

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.

K192111

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

Regulation Number and Section

§ 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.

Summary

0

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 25, 2024

Comfort Rubber Gloves Industries Sdn. Bhd. Sumanthi D/O Saravana Sami RA Manager Lot 821 Matang, Perak 34750 Malaysia

Re: K240269

Trade/Device Name: Nitrile Powder Free Examination Gloves Biodegradable (Green) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: April 2, 2024 Received: September 30, 2024

Dear Sumanthi D/O Saravana Sami:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

1

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).

2

Sincerely,

Image /page/2/Picture/3 description: The image shows the name "Bifeng Qian -S" in a large, sans-serif font. The text is black and stands out against a white background. The name appears to be a person's name, with "Bifeng" as the first name and "Qian" as the last name. The "-S" at the end could be an initial or a designation.

Bifeng Qian, M.D., Ph.D. Assistant Director DHT4C: Division of Infection Control Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

3

Indications for Use

Submission Number (if known)

K240269

Device Name

Nitrile Powder Free Examination Gloves Biodegradable (Green)

Indications for Use (Describe)

The Nitrile Powder Free Examination Gloves Biodegradable (Green) is a medical glove which is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between examiner and patient.

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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4

510(k) SUMMARY (K240269) Nitrile Powder Free Examination Gloves Biodegradable (Green)

1.0 Submitter:

Name	: Comfort Rubber Gloves Industries Sdn. Bhd
Address	: Lot 821, Jalan Matang,
34750 Matang, Perak, Malaysia.
Malaysia.
Phone No.	: 605-847 2777
Fax No.	: 605-847 9108
Contact Person:	: Sumathi d/o Sararavan Sami (Miss.)

Date of Preparation: January 8, 2024

2.0 Name of the Device

Nitrile Powder Free Examination Gloves Biodegradable (Green)

Common Name: Patient Examination Gloves

Classification Name: Non-powdered Patient Examination Gloves (21 CFR 880.6250 product code LZA)

3.0 Predicate Device

Device Name: Biodegradable Nitrile Examination Powder Free Glove, Green Company: Top Glove SDN BHD

510(K) No.: K192111

4.0 Description of the Device:

Nitrile Powder Free Examination Gloves Biodegradable (Green) meet all the requirements of ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application. The gloves are single use, disposable, and non-sterile. The gloves are offered in five sizes: S, M, L, XL, XXL.

5.0 Indication for Use of the Device

The Nitrile Powder Free Examination Gloves Biodegradable (Green) is a medical glove which is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between examiner and patient.

5

Image /page/5/Picture/1 description: The image shows a green nitrile powder-free examination glove. The glove is biodegradable and is laid flat on a white surface. The text at the top of the image indicates the type of glove, and the text at the bottom indicates that it is page 1 of 1.

6.0 Photo and/or figure of Nitrile Powder Free Examination Gloves Biodegradable (Green)

7.0 Technological Characteristics Comparison Table:

| CHARACTERISTICS | STANDARDS | PREDICATE DEVICE
K192111 | SUBJECT DEVICE
K240269 | COMPARISON | EXPLANATION |
|-----------------|-----------|-----------------------------|---------------------------|------------|-------------|
| Product Code | | LZA | LZA | Same | |

6

| Device Name | | Biodegradable Nitrile
Examination Powder
Free Glove, Green | Nitrile Powder Free
Examination Gloves
Biodegradable
(Green) | Similar | Device names are
different, but both
serve the same
intended use as
examination gloves. |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer(s) | | Top Gloves Sdn. Bhd. | Comfort Rubber
Gloves Industries
Sdn. Bhd | Different | Difference in
manufacturers.
Manufacturers
adhere to industry
standards and
regulations,
ensuring that their
products are
equally safe and
effective |
| Indication for Use | | The Biodegradable
Nitrile Examination
Powder Free Glove,
Green is a non-sterile
disposable device
intended for medical
purpose that is worn
on examiner's hand to
prevent contamination
between patient and
examiner. | The Nitrile Powder
Free Examination
Gloves
Biodegradable
(Green) is a medical
glove which is a
disposable device
intended for medical
purposes that is
worn on the
examiner's hand or
finger to prevent
contamination
between examiner
and patient. | Similar | The indications are
comparable,
indicating that both
products serve the
same function and
intended use within
clinical settings.
This similarity
reinforces the claim
of substantial
equivalence, as
both products are
designed to meet
the same clinical
needs and safety
standards |
| Material | ASTM D6319-19 | Nitrile | Nitrile | Same | - |
| Color | | Green | Green | Same | - |
| Size | Medical Glove
Guidance Manual
Labeling | Small | Small | - | - |
| | | Medium | Medium | Same | - |
| | | Large | Large | | |
| | | Extra Large | Extra Large | | |
| | | Double Extra Large | Double Extra Large | | |
| Single Use | Medical Glove
Guidance Manual | Single Use | Single Use | Same | - |
| Shelf life | Medical Glove
Guidance Manual | - | Accelerated 3 Years | Different | Does not impact
substantial
equivalence
because the shelf
life is determined by
specific stability
testing conducted
under relevant
conditions |
| Sterile | Medical Glove
Guidance Manual | Non-Sterile | Non-Sterile | Same | - |
| Dimension | ASTM D6319- 19 | Length-Min 230mm
Thickness palm and
finger- Min 0.05mm | Length-Min 230mm
Thickness palm and
finger-Min 0.05mm
Width -
S - 80±10mm
M - 95±10mm
L - 105 ± 5mm
XL - 115 ± 5mm
XXL -> 120 mm | Similar | Slight variation in
length (240 mm vs.
230 mm) does not
impact usability or
safety, as both
dimensions fall
within acceptable
ranges for
examination gloves |
| Physical Properties | ASTM D6319- 19 | Before Aging | | Similar | - |
| | | Tensile Strength
≥14MPa
Ultimate
Elongation≥500% | Tensile Strength
≥14MPa
Ultimate
Elongation≥500% | | |
| | | After Aging | | | The test result
reading might have
variance but meets
the ASTM D6319
requirement. |
| | | Tensile Strength
≥14MPa
Ultimate
Elongation≥400% | Tensile Strength
≥14MPa
Ultimate
Elongation≥400% | | |
| Thickness - Finger
– Palm | ASTM D6319-19 | Min 0.05
Min 0.05 | 0.16 mm - 0.20 mm
0.12 mm - 0.14 mm | Similar | The test result
reading might have
variance but meets
the ASTM D6319
requirement. |
| Residual Powder | ASTM 6124-06 -2022 | Max - 2 mg/glove | Max - 2 mg/glove
0.36 mg/glove | Same | |
| Biodegradable | ASTM D5511 | Tested | Tested | Similar | The test result
reading might have
variance but meets
the ASTM D5511
requirement. |
| | ISO 10993-23:2021
Biological evaluation
of medical devices
Part 23:Tests for
irritation | Under the conditions
of the study, the
subject device extracts
are not irritating to the
animal model. | Under the conditions
of the study, the
subject device is
non-irritating
extracts are not
irritating to the
animal model. | Same | -- |
| Biocompatibility | ISO 10993- 10:2021
Biological evaluation
of medical devices
Part 10: Tests for
skin sensitization | Under the conditions
of the study, the
subject device extracts
are not sensitizing to
the animal model. | Under the conditions
of the study, the
subject device
extracts are not
sensitizing to the
animal model. | Same | -- |
| | Cytotoxicity ISO
10993-5:2009 -
Biological evaluation
of medical devices --
Part 5: Tests for in
vitro cytotoxicity | Under the conditions
of the study, the
subject device extract
exhibits mild
cytotoxicity reactivity
result (2) with the neat
extract (100%). | Under the conditions
of the study, the
subject device
extract exhibits mild
cytotoxicity reactivity
result (2) with the
neat extract (100%). | Same | -- |
| | ISO 10993-11:2017
Biological evaluation
of medical devices
Part 11: Tests for
systemic toxicity | No test report was
submitted for the
predicate. | Under the conditions
of the study, did not
demonstrate any
acute toxic reaction. | Different | The Acute systemic
toxicity is additional
test tested to
evaluate the
potential for
systemic health
effects resulting
from exposure to
the materials used
in the gloves. |
| Watertight (1000ml) | 21 CFR 800.20
ASTM D5151 | Passes | Passes | Same | -- |

7

8

Summary of Non-Clinical Performance Data 8.0

Test Methodology	Purpose	Acceptance Criteria
ASTM D6319-19
Standard Specification
for Nitrile Examination
Gloves for Medical
Application	To determine the
length of the gloves	Min 230 for all sizes	Average:
S – 246
M – 246
L – 246
XL - 250
XXL - 254
	To determine the width
of the gloves	S – 80±10mm
M – 95±10mm
L – 105 ± 5mm
XL - 115 ± 5mm
XXL - > 120 mm	Average:
S – 86
M – 99
L – 106
XL - 115
XXL - 125
	To determine the
thickness of the gloves	Thickness palm and
finger- Min 0.05mm	Average:
Size Palm Finger S 0.13 0.19 M 0.13 0.19 L 0.13 0.18 XL 0.13 0.17 XXL 0.12 0.19

9

Test Methodology	Purpose	Acceptance Criteria	Results
ASTM D6319-19
Standard Specification
for Nitrile Examination
Gloves for Medical
Application	To determine the
Physical properties –
Tensile Strength	Before Aging – Min 14
MPa
After Aging - Min 14
MPa	Size	Before
Aging	After
Aging
			M	29.95	29.66
	To determine the
Physical properties -
Ultimate Elongation	Before Aging -
Min.500
After Aging - Min. 400	Size	Before
Aging	After
Aging
			M	561	496
ASTM D5151-19
Standard Test Method
for Detection of Holes
in Medical Gloves	To determine the holes
in the gloves	AQL 1.5		S – Pass AQL 1.5
				M – Pass AQL 1.5
				L – Pass AQL 1.5
				XL – Pass AQL 1.5
				XXL – Pass AQL 1.5
ASTM D6124-06(2022)
Standard Test Method
for Residual Powder on
Medical Gloves	To determine the
amount of residual
powder on the gloves	Max - 2 mg/glove		0.36mg
ASTM D5511-18
Standard Test Method
for Determining
Anaerobic
Biodegradation of
Plastic Materials
Under High-Solids
Anaerobic-Digestion
Condition	Determination of the
degree and rate of
anaerobic
biodegradation of
plastic materials in
high-solids anaerobic
conditions	Tested		Adjusted Percent
Biodegraded (%) – 7.2
ISO 10993-5
Biological evaluation
of medical devices-
Part 5 Tests for in
vitro cytotoxicity	To determine the
biological response of
mammalian cells in
vitro using appropriate
biological parameters	-		Under the conditions of
the study, the subject
device extract exhibits
mild cytotoxicity
reactivity result (2) with
the neat extract (100%).
ISO 10993-10:2021
Biological evaluation
of medical devices
Part 10: Tests for
skin sensitization	Assessment of medical
devices and their
constituent materials
with regard to their
potential to induce skin
sensitization	-		Under the conditions of
the study, the subject
device extracts are not
sensitizing to the animal
model.
ISO 10993-23:2021
Biological evaluation
of medical devices
Part 23: Tests for
irritation	Assessment of medical
devices and their
constituent materials
with regard to their
potential to produce
irritation	-		Under the conditions of
the study, the subject
device is non-irritating
extracts are not irritating
to the animal model.
ISO 10993-11:2017
Biological evaluation
of medical devices
Part 11: Tests for
systemic toxicity	Evaluation of the
potential for medical
device materials to
cause adverse
systemic reactions	-		Under the conditions of
the study, did not
demonstrate any
acute toxic reaction.

10

Non-clinical tests were conducted to demonstrate that the proposed device met all design specifications. The test results demonstrated that the proposed device met the performance criteria with the following standards:

ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application
. ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves
ASTM D5511-18 Standard Test Method for Determining Anaerobic Biodegradation of Plastic . Materials Under High-Solids Anaerobic-Digestion Condition
. ASTM D6124-06(2022) Standard Test Method for Residual Powder on Medical Gloves
ISO 2859 Sampling Procedures and Tables for Inspection by Attributes
. ISO 10993-5 Biological evaluation of medical devices-Part 5 Tests for in vitro cytotoxicity
. ISO 10993-10:2021 Biological evaluation of medical devices Part 10: Tests for skin sensitization
ISO 10993-23:2021 Biological evaluation of medical devices Part 23: Tests for irritation ●
ISO 10993-11:2017 Biological evaluation of medical devices Part 11: Tests for systemic toxicity .

9.0 Clinical Performance Data

Clinical data is not needed.

10.0 Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.