Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a standard examination glove and the summary contains no mention of AI or ML capabilities. The performance studies and metrics are based on physical and barrier properties, not algorithmic performance.

Therapeutic

No
Explanation: A therapeutic device is designed to treat or alleviate a medical condition. This device, Clover Glove Nitrile Examination Gloves, is described as a disposable device intended to prevent contamination, which is a protective function rather than a therapeutic one.

Diagnostic

No

Explanation: The device, Clover Glove Nitrile Examination Gloves, is described as a disposable device worn on the examiner's hand to prevent contamination. Its function is to provide a barrier, not to diagnose a condition or disease.

SaMD (Software as a Medical Device)

No

The device is a physical examination glove made of nitrile, clearly described as a disposable device worn on the hand. It is a hardware product, not software.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is clearly stated as "worn on the examiner's hand to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic function.
Device Description: The description focuses on the material, physical properties, and standards related to examination gloves. There is no mention of analyzing samples from the human body or providing diagnostic information.
Lack of Diagnostic Elements: The document does not mention any components or processes related to:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition.
Performance Studies: The performance studies focus on the physical properties, barrier integrity, and biocompatibility of the glove, which are relevant to its function as a protective barrier. They do not involve diagnostic accuracy metrics.

In summary, the Clover Glove Nitrile Examination Gloves are a medical device intended for barrier protection, not for in vitro diagnostic purposes.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Clover Glove Nitrile Examination Gloves Powder Free is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

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

LZA

Device Description

Clover Glove Nitrile Examination Gloves Powder Free is a Class I device bearing the product code LZA (21CFR 880.6250). They meet all the current specifications listed under the ASTM D6319 -19, Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from acrylonitrilebutadiene copolymer dispersion. These gloves are blue in color having Finger Texture, Ambidextrous and are powder free. The product is non-sterile.

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)

Performance Tests:

Dimension: Length, Width, and Thickness tested according to ASTM D6319-19. All sizes (S, M, L) passed acceptance criteria for length (Min 230mm) and width (Min 80mm±10 for S, Min 95mm±10 for M, Min 110mm±10 for L), and thickness (Min 0.05 mm for Palm and Finger for all sizes).
Physical property: Tensile strength and Ultimate Elongation tested according to ASTM D6319-19. All sizes (S, M, L) passed acceptance criteria for Tensile Strength (min 14 MPa before and after aging) and Ultimate Elongation (Min 500% before aging, Min 400% after aging).
Barrier property tests: Detection of Holes in Medical Gloves tested according to ASTM D6319-19 and ASTM D5151-19. Passed AQL 2.5 for all sizes.
Powder Free Residue: Tested according to ASTM D6124-06. All sizes (S, M, L) passed acceptance criteria of ≤2Mg/Glove Max.

Biocompatibility Tests according to ISO 10993-1:2018:

In Vitro Cytotoxicity: Showed positive cytotoxic response, but additional acute systemic toxicity testing demonstrated no systemic toxicity concern, indicating the cytotoxicity reactivity is not a significant concern in clinical settings.
Skin Sensitization: Passed (not a sensitizer).
Skin Irritation: Passed (not an irritant).
Acute Systemic Toxicity: Passed (device extracts do not pose a systemic toxicity concern).
Material Mediated Pyrogenicity: Passed (device did not demonstrate a material mediated pyrogenicity response).

Clinical study was not conducted as clinical data is not needed.

The conclusion drawn from the non-clinical tests demonstrate that the subject device, Clover Glove Nitrile Examination Gloves Powder free, is as effective, and performs as well as or better than the legally marketed predicate device, K192333.

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.

K192333

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

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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: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

March 26, 2022

Clover Glove Company Limited % Manoj Zacharias US Agent Liberty Management Group Limited 75 Executive Drive, Suite 114 Aurora, Illinois 60504

Re: K213729

Trade/Device Name: Clover Glove Nitrile Examination Gloves Powder Free Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I Product Code: LZA Dated: March 02, 2022 Received: March 07, 2022

Dear Manoj Zacharias:

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. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K213729

Device Name

Clover Glove Nitrile Examination Gloves Powder Free

Indications for Use (Describe)

Clover Glove Nitrile Examination Gloves Powder Free is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

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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Image /page/3/Picture/0 description: The image shows the logo for Clover Glove. The logo consists of a four-leaf clover on the left, with the top two leaves being green and the bottom left leaf being red. The bottom right leaf is also green. To the right of the clover is the word "CLOVER" in gray, with the "V" in red. Below the word "CLOVER" is a horizontal line, and below that is the word "GLOVE" in gray, with the "G" in orange.

510(k) SUMMARY (K213729)

[AS REQUIRED BY 21CFR807.92]

I. SUBMITTER

510(k) Owner's Name	Clover Glove Company Limited
Address	1999/8 District Sriwara Village, Ladphrao 94 (Punjamit),
Sriwara Rd, Plabphla, Wang Thong Lang, Krung Thep Maha
Nakhon, Thailand 10240
Telephone	+66 64 92 44991
Contact person	Mr.Pongsin Pongwachirint
Designation	Managing Director
Contact Email	pongsin.p@cloverglove.co.th
Date of Summary Prepared	25.03.2022

II. DEVICE

Device Trade Name	Clover Glove
Device Common Name	Nitrile Examination Gloves Powder Free
Device Classification name	Non-powdered patient examination glove
Regulation Number	21 CFR 880.6250
Class	I
Product Code	LZA

III. PREDICATE DEVICE

Predicate Device Name	Jr Medic Blue Nitrile Examination Gloves Powder Free
510(k) Number	K192333
Regulation Number	21 CFR 880.6250
Class	I
Product Code	LZA

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Image /page/4/Picture/0 description: The image shows the logo for Clover Glove. The logo consists of a four-leaf clover on the left, with the top two leaves being green and the bottom left leaf being red. The bottom right leaf is also green. To the right of the clover is the word "CLOVER" in gray letters, except for the "V" which is red. Below the word "CLOVER" is a green line, and below that is the word "GLOVE" in gray letters, except for the "G" which is orange.

IV. DEVICE DESCRIPTION

Clover Glove Nitrile Examination Gloves Powder Free is a Class I device bearing the product code LZA (21CFR 880.6250). They meet all the current specifications listed under the ASTM D6319 -19, Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from acrylonitrilebutadiene copolymer dispersion. These gloves are blue in color having Finger Texture, Ambidextrous and are powder free. The product is non-sterile.

V. INDICATIONS OF USE

Clover Glove Nitrile Examination Gloves Powder Free is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

| SI.

No	Features compared	Proposed Device	Predicate Device	Result
General Information
1.	510(k) Number	K213729	K192333	-
2.	Manufacturer	Clover Glove Company Limited	JR Engineering & Medical
Technologies (M) SDN.BHD	-
3.	Classification	I	I	Same
4.	Regulation number	21 CFR 880.6250	21 CFR 880.6250	Same
5.	Product Code	LZA	LZA	Same
6.	Indication For Use	Clover Glove Nitrile Examination
Gloves Powder Free is a disposable
device intended for medical
purpose that is worn on the
examiner's hand to prevent
contamination between patient
and examiner.	Jr Medic Blue Nitrile Examination
Gloves Powder Free are intended
for medical purposes that is worn
on the examiner's hands to
prevent contamination between
patient and examiner.	Same
7.	Material	Nitrile	Nitrile	Same
8.	Color	Blue	Blue	Same
9.	Texture	Finger Texture	Finger texture	Same
10.	Ambidextrous	Yes	Data not available	-
11.	Size	S, M, L	XS, S, M, L, XL	Similar
12.	OTC Use	Yes	Yes	Same
SI.
No	Features compared	Proposed Device	Predicate Device	Result
13.	Reusability	Single use	Single use	Same
14.	Sterility	Non- sterile	Non- sterile	Same
15.	Dimensions	Length Min 230 mm
Width Min 95±10
Mm (for medium size)	Length Min 230 mm
Width Min 95±10
Mm (for medium size)	Same
16.	Thickness	Palm min 0.05 mm
Finger min 0.05 mm	Palm min 0.05 mm
Finger min 0.05 mm	Same
17.	Physical Properties	Before Aging
Tensile Strength min 14 MPa
Ultimate Elongation Min 500%
After Aging
Tensile Strength min 14 MPa
Ultimate Elongation Min 400%	Before Aging
Tensile Strength min 14 MPa
Ultimate Elongation Min 500%
After Aging
Tensile Strength min 14 MPa
Ultimate Elongation Min 400%	Same
18.	Detection of Holes	Passes AQL 2.5	Passes AQL 1.5	Similar
19.	Powder Free Residue	≤2 mg/glove Max	≤2 mg/glove Max	Same
20.	Shelf Life	3 Years	Data Not Available	-
21.	Biocompatibility Study	In Vitro Cytotoxicity	Under the conditions of the study,
cytotoxic. Additional testing was
performed to determine if this was
a systemic toxicity concern.	Under the conditions of the study,
cytotoxic. Additional testing was
performed to determine if this
was a systemic toxicity concern.	Same
		Skin Sensitization	Under the condition of the study
not a sensitizer	Under the condition of the study
not a sensitizer	Same
		Skin Irritation	Under the condition of the study
not an irritant	Under the condition of the study
not an irritant	Same
		Acute Systemic
Toxicity	Under the conditions of study, the
device extracts do not pose a
systemic toxicity concern	Under the conditions of study, the
device extracts do not pose a
systemic toxicity concern	Same
		Material Mediated
Pyrogenicity	Under the conditions of the study, the
device did not demonstrate a
material mediated pyrogenicity
response.	Under the conditions of the
study, the device did not
demonstrate a material mediated
pyrogenicity response.	Same

Table 1: General Comparison

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Image /page/5/Picture/0 description: The image shows the logo for Clover Glove. The logo consists of a four-leaf clover on the left and the words "CLOVER GLOVE" on the right. The clover has two green leaves, one red leaf, and one yellow leaf. The words "CLOVER GLOVE" are in gray, with the "V" in "CLOVER" being red and the "G" in "GLOVE" being yellow. A green line separates the two words.

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Image /page/6/Picture/0 description: The image is a logo for Clover Glove. The logo consists of a four-leaf clover on the left and the words "CLOVER GLOVE" on the right. The clover is made up of four circles, with the top left circle being red, the top right and bottom left circles being green, and the bottom right circle being orange. The word "CLOVER" is in gray, except for the letter "V", which is red. The word "GLOVE" is in gray, except for the letter "G", which is orange.

PERFORMANCE DATA VII.

A. Non- Clinical Data

Performance Tests

Clover Glove Nitrile Examination Gloves Powder Free is subjected to the following performance tests according to the requirements of Guidance for Industry and FDA Staff - Medical Glove Guidance Manual and found to be safe and efficient with respect to its intended use:

Dimension
Physical property
Barrier property tests
- Δ Detection of Holes in Medical Gloves
Powder Free Residue

| SI
No. | Tests | Actual Data | | | Acceptance Criteria | | |-----------|------------------------------------------------------------------------------------------------------|-- | 1. | | Size | | Dimension
Length, Width and
Thickness | S | 245.15mm | | | M | | | L | | ASTM D6319-19 | | Standard Specification for
Nitrile Examination Gloves
for Medical Application | Size | Palm | Finger | Size | | | S | | | M | | | L | 2. | | | | Physical property
Tensile strength and
Ultimate Elongation | Size | Before
Aging | After
Aging | Size | Before
Aging | After
Aging | |
| | | S | | | M | | | L | | ASTM D6319-19
Standard Specification for
Nitrile Examination Gloves
for Medical Application | | Ultimate Elongation | | | | | Size Aging | After
Aging | Size | Before
Aging | After
Aging | |
| | | S | | | M | | | L Proposed Device
| Result |
------------------------------|---------------------|----------------|---------------------|---------------------|----------------|--------|
| Length | Width | Size | Length | Width | |
| 83mm | S | | 80mm±10 | Pass |
| 247.1 mm | 92.69 mm | M | 230mm Min | 95mm ±10 | |
| 248.30mm | 108.07mm | L | | 110mm ±10 | |
| Thickness | | | Thickness | | | |
| Palm | Finger | |
| 0.08 mm | 0.123mm | S | 0.05 mm | 0.05 mm | Pass |
| 0.09 mm | 0.138mm | M | Min | Min | |
| 0.09 mm | 0.14mm | L | | | |
| Tensile strength | | Tensile strength | | | |
| 30.60 MPa | 30.66 MPa | S | 14 MPa | 14 MPa | Pass |
| 31.72 MPa | 30.80 MPa | M | Min | Min | |
| 37.01 MPa | 35.46 MPa | L | | | |
| Ultimate Elongation | | |
| Before
| 604.61% | 573.84% | S | 500% | 400% | |
| 575.38% | 580% | M | Min | Min | |
| 596.92% | 566.15% | L | | | |

Table 2: Performance Testing Summary

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Image /page/7/Picture/0 description: The image shows the logo for Clover Glove. The logo has a four-leaf clover on the left side, with the top two leaves being green and the bottom left leaf being red and the bottom right leaf being green. To the right of the clover is the word "CLOVER" in gray, with the "V" in red. Below the word "CLOVER" is a green line, and below that is the word "GLOVE" in gray, with the "G" in orange.

| SI
No. | Tests | Proposed Device
Actual Data | | Acceptance Criteria | | Result |
|-----------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|-------------------------|-----------------------|-------------------------|--------|
| 3. | Barrier property tests
Detection of Holes in
Medical Gloves
ASTM D6319-19
ASTM D5151-19
Standard Test Method for
Detection of Holes in Medical
Gloves | AQL 2.5 for all sizes | | AQL 2.5 for all sizes | | Pass |
| 4. | Powder Free Residue | Size | Residual powder content | Size | Residual powder content | |
| | ASTM D6124-06
(Reapproved 2017) | S | 0.42mg | S | | Pass |
| | Standard Test Method for | M | 0.34mg | M | ≤2Mg/ Glove Max | |
| | Residual Powder on Medical
Gloves | L | 0.20mg | L | | |

Biocompatibility B.

The materials used in the Clover Glove Nitrile Examination Gloves Powder Free are biocompatible based on the biocompatibility tests mentioned in the Guidance for Industry and FDA Staff - Medical Glove Guidance Manual:

In Vitro Cytotoxicity
Skin Sensitization
Skin Irritation
Acute Systemic Toxicity
Material Mediated Pyrogenicity

These tests were performed according to ISO 10993-1:2018, Biological Evaluation of Medical Devices -Part 1, Evaluation and Testing within a Risk Management Process.

	Table 3: Biocompatibility Test Summary
--	----------------------------------------	--

| SI.

No	Test Performed	Proposed Device
1.	In Vitro Cytotoxicity	Under the conditions of the study,
cytotoxic.
Additional
testing
was
performed to determine if this was a
systemic toxicity concern.	Under the conditions of the
study, non-cytotoxic.	Different
2.	Skin Sensitization	Under the conditions of the study not
a sensitizer	Under the conditions of the
study not a sensitizer	Pass
3.	Skin Irritation	Under the condition of study not an
irritant	Under the condition of study
not an irritant	Pass

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Image /page/8/Picture/0 description: The image shows the logo for Clover Glove. The logo has a four-leaf clover on the left side, with the top two leaves being green and the bottom left leaf being red. The bottom right leaf is also green. To the right of the clover is the word "CLOVER" in gray letters, except for the "V" which is red. Below the word "CLOVER" is a green line, and below that is the word "GLOVE" in gray letters, except for the "G" which is yellow.

4.	Acute Systemic Toxicity	Under the conditions of study, the device extracts do not pose a systemic toxicity concern	Under the conditions of study, the device extracts do not pose a systemic toxicity concern
5.	Material
Mediated
Pyrogenicity	Under the condition of the study, The device did not demonstrate a Material mediated pyrogenicity response	Under the conditions of the study, the device did not demonstrate a material mediated pyrogenicity response.	Pass

- Since the cytotoxic study showing positive cytotoxic response, additional testing for acute systemic toxicity is conducted to determine if this was a systemic toxicity concern and it showed that the subject glove did not induce systemic toxicity in the test animals, which demonstrated that the cytotoxicity reactivity observed is not a significant concern in clinical settings.

C. Clinical Test Data

Clinical study was not conducted as clinical data is not needed for Clover Glove Nitrile Examination Gloves Powder Free.

VIII. CONCLUSION

The conclusion drawn from the non-clinical tests demonstrate that the subject device in 510(k) submission, Clover Glove Nitrile Examination Gloves Powder free is as effective, and performs as well as or better than the legally marketed predicate device, K192333.