O'Star 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.

Device Description

O'Star 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.

AI/ML Overview

This document (K213058) is a 510(k) Premarket Notification for O'Star Nitrile Examination Gloves Powder Free. It primarily focuses on demonstrating substantial equivalence to a predicate device (K210276) through non-clinical performance and biocompatibility testing. The data provided is for the verification and validation of the physical properties and biocompatibility of the gloves, not for an AI/algorithm-based medical device.

Therefore, many of the requested items regarding AI/algorithm performance (e.g., sample size for training set, number of experts for ground truth, MRMC studies, AI assistance effect size) are not applicable to this type of medical device submission.

Here's the breakdown of the information provided in the document concerning the acceptance criteria and the study proving the device meets them:

1. A table of acceptance criteria and the reported device performance:

The document provides two tables in Section VII. PERFORMANCE DATA.

Table 2: Performance Testing Summary - This table details the physical and barrier properties of the gloves.

SI No.	Tests	Proposed Device actual Data	Acceptance Criteria	Result
1.	Dimension Length, Width and Thickness ASTM D6319-19 /ASTM D412-16/ASTM D3767-03-(Reapproved2020) Standard Specification for Nitrile Examination Gloves for Medical Application	Length S: 247.2mm M: 243.8mm L: 245.5mm XL: 247.2mm Width S: 90mm M: 103.7mm L: 104.2mm XL: 110.2mm Thickness S: Palm 0.055mm, Finger 0.052mm M: Palm 0.052mm, Finger 0.053mm L: Palm 0.053mm, Finger 0.053mm XL: Palm 0.057mm, Finger 0.053mm	Length M: 230mm min (Note: Specific length criteria for S, L, XL are not explicitly listed in the "Acceptance Criteria" column, but based on the "Pass" result and the general ASTM standard, it implies they met standard) Width S: 80mm±10 M: 95mm±10 L: 110mm±10 XL: 120mm±10 Thickness Palm: 0.05 mm min Finger: 0.05 mm min	Pass
2.	Physical property Tensile strength and Ultimate Elongation ASTM D6319-19/ASTM D573-04 (Reapproved 2019) Standard Specification for Nitrile Examination Gloves for Medical Application	Tensile strength Before Aging: S: 14.23 Mpa, M: 15.85 Mpa, L: 14.92 Mpa, XL: 15.32 Mpa After Aging: S: 14.07Mpa, M: 14.09 Mpa, L: 14.13 Mpa, XL: 14.81 Mpa Ultimate Elongation Before Aging: S: 702%, M: 935%, L: 768%, XL: 831% After Aging: S: 694%, M: 836%, L: 728%, XL: 785%	Tensile strength Before Aging: 14Mpa Min for all sizes After Aging: 14Mpa Min for all sizes Ultimate Elongation Before Aging: 500% Min for all sizes After Aging: 400%Min for all sizes	Pass
3.	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	AQL=2.5	Pass
4.	Powder Free Residue ASTM D6124-06(Reapproved2017) Standard Test Method for Residual Powder on Medical Gloves	Residual powder content S: 0.03 mg M: 0.07 mg L: 0.01 mg XL: 0.05 mg	≤2 Mg/Glove Max for all sizes	Pass

Table 3: Biocompatibility Test Summary - This table details the biological safety of the gloves.

SI. No	Test Performed	Proposed Device	Acceptance Criteria	Result
1.	Invitro Cytotoxicity	Under the conditions of the study, cytotoxic to L-929 cells. Additional Testing was performed to determine if this was a systemic toxicity concern.	Under the conditions of the study, not cytotoxic.	Pass
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
4.	Acute Systemic Toxicity	Under the conditions of the study, the device extracts do not pose a systemic toxicity concern.	Under the conditions of the study, the device extracts do not pose a systemic toxicity concern.	Pass

2. Sample sizes used for the test set and the data provenance:

Sample Size for Test Set: The document does not explicitly state the sample sizes (number of gloves) for each physical and biocompatibility test performed. However, for a 510(k) submission, implied sample sizes for such tests typically follow the requirements of the referenced ASTM and ISO standards. These standards specify sample sizes for testing batches of gloves to ensure compliance.
Data Provenance: The manufacturer's address is listed as "Khac Niem Industrial Cluster, Khac Niem Ward, Bac Ninh City, Bac Ninh Province, Vietnam." This implies the testing was likely conducted in Vietnam or by labs accredited by Vietnamese or international standards, reflecting the country of origin of the data. The data is retrospective, as it was generated from pre-market testing to support the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This question is not applicable as this submission is for a physical medical device (gloves), not an AI/algorithm. Ground truth in this context is established by laboratory measurements according to established international standards (ASTM, ISO).

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This question is not applicable for a physical device. Testing results are based on objective measurements and established standards, not human adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This question is not applicable as this submission is for a physical medical device (gloves), not an AI/algorithm. No human readers or AI assistance are involved in the performance evaluation of examination gloves.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This question is not applicable as this submission is for a physical medical device (gloves), not an AI/algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the performance of these gloves is established by objective laboratory measurements against predefined international standard specifications (ASTM D6319-19, ASTM D412-16, ASTM D3767-03, ASTM D573-04, ASTM D5151-19, ASTM D6124-06) for physical properties (dimensions, tensile strength, elongation, hole detection, powder residue) and biological testing standards (ISO 10993-1:2018) for biocompatibility (cytotoxicity, skin sensitization, skin irritation, acute systemic toxicity).

8. The sample size for the training set:

This question is not applicable as this submission is for a physical medical device (gloves), not an AI/algorithm. There is no "training set" in the context of device testing for physical properties unless referring to batch manufacturing quality control, which is implied by the adherence to standards.

9. How the ground truth for the training set was established:

This question is not applicable as this submission is for a physical medical device (gloves), not an AI/algorithm.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

February 8, 2022

Star Investment And Trade Joint Stock Company % Manoj Zacharias US Agent Liberty Management Group Limited 75 Executive Drive, Suite 114 Aurora, Illinois 60504

Re: K213058

Trade/Device Name: O'Star Nitrile Examination Gloves Powder Free Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I, reserved Product Code: LZA Dated: September 8, 2021 Received: September 22, 2021

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.

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

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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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Clarence W. Murray, III, 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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K213058

Device Name

O'Star Nitrile Examination Gloves Powder Free

Indications for Use (Describe)

O'Star 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)
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☐ Residential Use (24 CFR 881 Subpart D)	☑ Other Than Subsidized (24 CFR 881 Subpart C)
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__ Prescription Use (Part 21 CFR 801 Subpart D)

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 O'Star. The logo features a stylized star shape in shades of green and blue, with the word "O'Star" in blue, with the apostrophe in the same color. The overall design is modern and clean.

STAR INVESTMENT AND TRADE JOINT STOCK COMPANY

Manufacturer address: Khac Niem Industrial Cluster, Khac Niem Ward, Bac Ninh City, Bac Ninh Province, Vietnam. Telephone No: +84 22 23 810 962 Email: ostargloves.business@gmail.com

510(k) SUMMARY (K213058)

[AS REQUIRED BY 21CFR807.92]

I. SUBMITTER

510(k) Owner's Name	:	STAR INVESTMENT AND TRADE JOINT STOCK COMPANY
Address	:	Khac Niem Industrial Cluster, Khac Niem Ward, Bac Ninh City,Bac Ninh Province, 16000, Vietnam
Telephone	:	+84 22 23 810 962
Contact person	:	DO VAN BINH
Designation	:	Chairman & General Director
Contact Number	:	+84 984 990 992
Contact Email	:	thutrang.tpp2001@gmail.com
Date of Summary Prepared	:	05.01.2022

DEVICE II.

Brand Name	: O'Star Nitrile Examination Gloves Powder Free
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	Disposable Nitrile Gloves
510(k) Number	K210276
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 O'Star. The logo features a stylized star shape in green and blue, with the word "O'Star" in blue, with the "O" being larger than the rest of the letters. The star shape is positioned above and to the left of the text.

IV. DEVICE DESCRIPTION

V. INTENDED USE

O'Star 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	K213058	K210276	-
2.	Manufacturer	STAR INVESTMENT ANDTRADE JOINT STOCK COMPANY	FUJIAN ERCON MEDICALMANAGEMENT CO., LTD.	-
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	O'Star Nitrile Examination GlovesPowder Free is a disposable deviceintended for medical purpose thatis worn on the examiner's hand toprevent contaminationbetweenpatient and examiner.	Disposable Nitrile ExaminationGloves Powder Free is disposabledevices intendedfor medicalpurpose that are worn on theexaminer's hand to preventcontamination between patientand examiner.	Same
7.	Material	Nitrile	Nitrile	Same
8.	Color	Blue	Blue	Same
9.	Texture	Finger Texture	Finger Texture	Same
10.	Ambidextrous	Yes	Yes	Same
11.	Size	S, M, L, XL	S, M, L, XL	Same

Table 1: General Comparison

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Image /page/5/Picture/0 description: The image shows the logo for O'Star. The logo features a green and blue star above the text "O'Star" in blue. The text is stylized with a wave-like design underneath.

SI.No	Features compared	Proposed Device	Predicate Device	Result
12.	OTC Use	Yes	Yes	Same
13.	Reusability	Single use	Single use	Same
14.	Sterility	Non- sterile	Non- sterile	Same
15.	Dimensions	Length=min 230±10 mmWidth= min 95±10 mm(For medium size)	Length=min 230±10 mmWidth= min 95±10 mm(For medium size)	Same
16.	Thickness	Palm min 0.05 mmFinger min 0.05 mm	Palm min 0.05 mmFinger min 0.05 mm	Same
17.	Physical Properties	Before AgingTensile Strength min 14 MpaUltimate Elongation min 500%After AgingTensile Strength min 14 MpaUltimate Elongation min 400%	Before AgingTensile Strength min 14 MpaUltimate Elongation min 500%After AgingTensile Strength min 14 MpaUltimate Elongation min 400%	Same
18.	Detection of Holes	AQL=2.5	AQL=2.5	Same
19.	Powder Free Residue	≤2 mg/glove	≤2 mg/glove	Same
20.Biocompatibility Study	Invitro Cytotoxicity	Under the conditions of the study,cytotoxic to L-929 cells. AdditionalTesting was performed todetermine if this was a systemictoxicity concern	Under the conditions of thestudy, not cytotoxic.	Different
	Skin Sensitization	Under the conditions of the study,not a sensitizer	Under the conditions of thestudy, not a sensitizer	Same
	Skin Irritation	Under the condition of study notan irritant	Under the condition of study notan irritant	Same
	Acute SystemicToxicity	Under the conditions of the study,the device extracts do not pose asystemic toxicity concern	Data not available	-

There are no significant differences between the two products and are identical in terms of intended use, materials, design, manufacturing methods. Both devices meet the ASTM standard D6319-19.

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Image /page/6/Picture/0 description: The image shows the logo for O'Star. The logo features a green and blue star-like shape on the left, followed by the text "O'Star" in blue. The logo has a clean and modern design.

VII. PERFORMANCE DATA

Non- Clinical Data A.

Performance Tests

O'Star 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- Detection of Holes in Medical Gloves
Powder Free Residue

Table 2: Performance Testing Summary

SI No.	Tests	Proposed Device actual Data			Acceptance Criteria			Result
1.	Dimension	Size	Length	Width	Size	Length	Width
	Length, Width andThickness	S	247.2mm	90mm	S		80mm±10	Pass
	ASTM D6319-19 /ASTM	M	243.8mm	103.7mm	M	230mm min	95mm±10
	D412-16/ASTM D3767-	L	245.5mm	104.2mm	L		110mm±10
	03-(Reapproved2020)	XL	247.2mm	110.2mm	XL		120mm±10
		Thickness			Thickness
	Standard Specification	Size	Palm	Finger	Size	Palm	Finger
	for Nitrile Examination	S	0.055mm	0.052mm	S
	Gloves for MedicalApplication	M	0.052mm	0.053mm	M	0.05 mm min	0.05 mm min
		L	0.053mm	0.053mm	L
		XL	0.057mm	0.053mm	XL
2.	Physical propertyTensile strength andUltimate Elongation	Tensile strength			Tensile strength
		Size	BeforeAging	AfterAging	Size	BeforeAging	AfterAging
		S	14.23 Mpa	14.07Mpa	S			Pass
		M	15.85 Mpa	14.09 Mpa	M	14Mpa Min forall sizes	14Mpa Min forall sizes
	ASTM D6319-19/ASTM	L	14.92 Mpa	14.13 Mpa	L
	D573-04 (Reapproved2019)	XL	15.32 Mpa	14.81 Mpa	XL
		Ultimate Elongation			Ultimate Elongation
	Standard Specificationfor Nitrile Examination	Size	BeforeAging	AfterAging	Size	BeforeAging	AfterAging
	Gloves for Medical	S	702%	694%	S
	Application	M	935%	836%	M	500% Min forall sizes	400%Min forall sizes
		L	768%	728%	L

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Image /page/7/Picture/0 description: The image shows the logo for O'Star. The logo features a stylized star shape in the upper left corner, with a gradient of green to blue. The text "O'Star" is written in a bold, blue font to the right of the star. The overall design is simple and modern.

SI No.	Tests	Proposed Device actual Data	Acceptance Criteria	Result
3.	Detection of Holes inMedical GlovesASTM D6319-19 /ASTMD5151-19Standard Test Methodfor Detection of Holesin Medical Gloves	AQL=2.5	AQL=2.5	Pass
4.	Powder Free ResidueASTM D6124-06(Reapproved2017)Standard Test Methodfor Residual Powder onMedical Gloves	SizeResidual powder content	SizeResidual powder content
		S0.03 mg	S	Pass
		M0.07 mg	M≤2 Mg/Glove Max
		L0.01 mg	L
		XL0.05 mg	XL

B. Biocompatibility

The materials used in the O'Star 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:

Invitro Cytotoxicity .
. Skin Sensitization
. Skin Irritation
. Acute Systemic Toxicity

These tests are 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	Acceptance Criteria	Result
1.	Invitro Cytotoxicity	Under the conditions of thestudy, cytotoxic to L-929 cells.Additional Testing wasperformed to determine if thiswas a systemic toxicity concern	Under the conditions of thestudy, not cytotoxic.	Pass
2.	Skin Sensitization	Under the conditions of thestudy not a sensitizer	Under the conditions of thestudy not a sensitizer	Pass

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Image /page/8/Picture/0 description: The image shows the logo for O'Star. The logo features a stylized star shape in shades of green and blue, with the word "O'Star" in blue, bold font. The star is positioned to the left of the text, and the overall design is clean and modern.

3.	Skin Irritation	Under the condition of study notan irritant	Under the condition of studynot an irritant	Pass
4.	Acute Systemic Toxicity	Under the conditions of thestudy, the device extracts do notpose a systemic toxicity concern.	Under the conditions of thestudy, the device extracts donot pose a systemic toxicityconcern	Pass

C. Clinical Test Data

Clinical study was not conducted as clinical data is not needed for O'Star Nitrile Examination Gloves Powder Free.

VIII. CONCLUSION

The conclusion drawn from the non-clinical tests demonstrate that the subject device, O'star Nitrile Examination Glove Powder Free are as safe, as effective and perform as well as or better than legally marketed predicate device in K210276.

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.