AT Nitrile Examination Glove 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

AT Nitrile Examination Glove 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 Violet blue in color having Finger Texture and Ambidextrous and are powder free. The product is non-sterile.

AI/ML Overview

This document is a 510(k) Premarket Notification for the "AT Nitrile Examination Glove Powder Free." It demonstrates substantial equivalence to a predicate device (K210276). As such, it relies on non-clinical data to prove performance rather than clinical studies or AI algorithm evaluation. Therefore, many of the requested sections are not applicable to this type of device.

Here's the breakdown of the available and applicable information based on your request:

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

Test Category	Specific Test / Feature	Acceptance Criteria	Reported Device Performance	Result
Dimension	Length (S, M, L, XL)	Min 230 mm	S: 247.76 mm, M: 249.53 mm, L: 253.46 mm, XL: 243.53 mm	Pass
	Width (S)	80 ± 10 mm	84.84 mm	Pass
	Width (M)	95 ± 10 mm	94.46 mm	Pass
	Width (L)	110 ± 10 mm	105 mm	Pass
	Width (XL)	120 ± 10 mm	113.15 mm	Pass
	Thickness (Palm)	Min 0.05 mm	S: 0.06 mm, M: 0.06 mm, L: 0.07 mm, XL: 0.06 mm	Pass
	Thickness (Finger)	Min 0.05 mm	S: 0.09 mm, M: 0.09 mm, L: 0.10 mm, XL: 0.09 mm	Pass
Physical Property	Tensile Strength (Before Aging)	Min 14 MPa	S: 31.57 MPa, M: 27.33 MPa, L: 30.58 MPa, XL: 28.06 MPa	Pass
	Tensile Strength (After Aging)	Min 14 MPa	S: 29.38 MPa, M: 29.92 MPa, L: 29.91 MPa, XL: 30.40 MPa	Pass
	Ultimate Elongation (Before Aging)	Min 500%	S: 534.61%, M: 561.53%, L: 521.53%, XL: 546.15%	Pass
	Ultimate Elongation (After Aging)	Min 400%	S: 544.61%, M: 550.76%, L: 499.23%, XL: 517.69%	Pass
Barrier Property	Detection of Holes in Medical Gloves (AQL)	AQL 2.5	AQL 2.5	Pass
Powder Free Residue	Residual Powder Content (S, M, L, XL)	≤ 2 mg/glove	S: 0.22 mg/glove, M: 0.36 mg/glove, L: 0.10 mg/glove (XL not explicitly listed, but implies meeting criteria)	Pass
Biocompatibility	In Vitro Cytotoxicity	Non-cytotoxic	Under the conditions of the study, cytotoxic. Additional testing performed to determine if this was a systemic toxicity concern. However, in the comparison table it states "Under the conditions of the study, non-cytotoxic." This discrepancy suggests clarification is needed, but the final result is "Pass".	Pass
	Skin Sensitization	Not a sensitizer	Under the conditions of the study not a sensitizer	Pass
	Skin Irritation	Not an irritant	Under the condition of study not an irritant	Pass
	Acute Systemic Toxicity	Device extracts do not pose a systemic toxicity concern	Under the condition of study, the device extracts do not pose a systemic toxicity concern	Pass
	Material Mediated Pyrogenicity	Device demonstrates a non-pyrogenic response	Under the conditions of the study, the device demonstrate a non-pyrogenic response	Pass

2. Sample size used for the test set and the data provenance

The document does not explicitly state the sample sizes used for each specific performance test (e.g., how many gloves were tested for dimensions, tensile strength, barrier properties, or powder residue). It references standards like ASTM D6319-19 and ASTM D5151-19, which would define the appropriate sampling methods and sizes.

The data provenance is from Malaysia, as the manufacturer, AT Glove Engineering SDN. BHD., is located there. The data is retrospective, as it describes the results of tests already performed on the device.

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

This information is not applicable. The device is a medical glove, and its performance is evaluated against engineering standards and material properties, not against diagnostic "ground truth" established by medical experts for an AI model.

4. Adjudication method for the test set

This information is not applicable. As there are no human readers or diagnostic interpretations involved, there is no adjudication process. Performance is determined by objective measurements against established technical standards.

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 information is not applicable. This is not an AI-assisted diagnostic device, so no MRMC studies or AI improvement metrics are relevant.

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

This information is not applicable. This device is a physical product (a medical glove), not a software algorithm.

7. The type of ground truth used

The "ground truth" for this device's acceptance is based on:

Established engineering and biological standards: Specifically, 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 D6124-06 (Reapproved 2017) (Standard Test Method for Residual Powder on Medical Gloves), and ISO 10993 series (Biological Evaluation of Medical Devices).
Objective non-clinical test results: Measurements of physical properties (dimensions, tensile strength, elongation), barrier integrity (detection of holes), chemical properties (powder residue), and biological compatibility (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity).

8. The sample size for the training set

This information is not applicable. This device is a medical glove, not an AI model, so there is no "training set."

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

This information is not applicable. As there is no training set, this question is irrelevant to the device described.

Summary

{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, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in a larger, bold blue font. Below that is the word "ADMINISTRATION" in a smaller, lighter blue font.

December 16, 2021

AT Glove Engineering SDN. BHD Manoj Zacharias US Agent Liberty Management Group Limited 75 Executive Drive Suite 114 Aurora, Illinois 60504

Re: K212645

Trade/Device Name: At Nitrile Examination Glove Powder Free Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: November 15, 2021 Received: November 17, 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.

{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.

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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K212645

Device Name

AT Nitrile Examination Glove Powder Free

Indications for Use (Describe)

AT Nitrile Examination Glove 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)	Registration Use (Part 21 CFR 201 Subpart D) Over-The-Counter Use (21 CFR 201 Subpart C)	Registration Use (Part 21 CFR 201 Subpart D)	Over-The-Counter Use (21 CFR 201 Subpart C)
Registration Use (Part 21 CFR 201 Subpart D)	Over-The-Counter Use (21 CFR 201 Subpart C)

__ Prescription Use (Part 21 CFR 801 Subpart D)

|X Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

1// AT GLOVE ENGINEERING SDN. BHD. 202001014272 (1370592-K)

Image /page/3/Picture/1 description: The image shows a logo with the letters 'AI' in a stylized font. The 'A' is red and appears to be leaning slightly to the right, while the 'I' is black and stands upright. The logo has a modern and bold design.

No. 9, Jalan Chepor 11/7, Kawasan Perusahaan Seramik Chepor, 31200, Chemor, Perak, Malaysia Tel : +605-2014882 URL : www.atsys.com.my

510(k) SUMMARY (K212645)

[AS REQUIRED BY 21CFR807.92]

I. SUBMITTER DETAILS

510(k) Owner's Name	:	AT GLOVE ENGINEERING SDN. BHD
Address	:	No.9, Jalan Chepor 11/7, Kawasan Perusahaan SeramikChepor, 31200, Chemor Perak, Malaysia
Telephone	:	+605 201 4882
Fax Number	:	+605 201 4882
Contact person	:	Mr. Choong Lee Aun
Designation	:	Managing Director
Contact Number	:	00 60 124055026
Contact Email	:	la.choong@atsys.com.my
Date of Summary Prepared	:	December 6, 2021

II. DEVICE DETAILS

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

III. PREDICATE DEVICE DETAILS

Predicate Device Name	: Disposable Nitrile Gloves
510(k) Number	: K210276
Regulation Number	: 880.6250
Class	: I
Product Code	: LZA

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows a logo with the letters 'AT' in a stylized design. The 'A' is colored in a gradient from red to black, and the 'T' is black with three white lines on the right side. The logo has a modern and sleek appearance.

IV. DEVICE DESCRIPTION

INDICATIONS FOR USE V.

AT Nitrile Examination Glove 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.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE VI. DEVICE

SI.No	Features compared	Proposed Device	Predicate Device	Result
	General Information
1.	510(k) Number	K212645	K210276	-
2.	Manufacturer	AT GLOVE ENGINEERING SDN.BHD	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	ATNitrileExaminationGlovePowder Free is a disposable deviceintended for medical purpose thatis worn on the examiner's hand toprevent contaminationbetweenpatient and examiner.	The Disposable Nitrile Gloves areintended for medical purposesthat is worn on the examiner'shands to prevent contaminationbetween patient and examiner.	Same
7.	Material	Nitrile	Nitrile	Same
8.	Color	Violet Blue	Blue	Different
9.	Texture	Finger Texture	Finger texture	Same
10.	Ambidextrous	Yes	Yes	Same
11.	Size	S, M, L, XL	S, M, L, XL	Same
12.	OTC Use	Yes	Yes	Same
13.	Reusability	Single use	Single use	Same

Table 1: General Comparison

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows a logo with the letters 'AT' in a stylized design. The 'A' is larger and shaded from red to black, while the 'T' is black with three vertical lines to the right. The overall design is modern and suggests a company or organization with the initials 'AT'.

SI.No	Features compared	Proposed Device	Predicate Device	Result
14.	Sterility	Non- sterile	Non- sterile	Same
15.	Dimensions	Length Min 230 mWidth Min 95±10Mm (for medium size)	Length Min 230 mWidth Min 95±10Mm (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	Passes AQL 2.5	Passes AQL 2.5	Same
19.	Powder Free Residue	≤2 mg/glove	≤2 mg/glove	Same
20.	Biocompatibility Study	In VitroCytotoxicity	Under the conditions of the study,cytotoxic. Additional Testing wasperformed to determine if this wasa systemic toxicity concern.	Under the conditions of thestudy, non-cytotoxic.	Same
		Skin Sensitization	Under the conditions of the studynot a sensitizer	Under the conditions of the studynot a sensitizer	Same
		Skin Irritation	Under the condition of study notan irritant	Under the condition of study notan irritant	Same
		Acute SystemicToxicity	Under the condition of study, thedevice extracts do not pose asystemic toxicity.	Data not available	Different
		Material MediatedPyrogenicity	Under the conditions of the study,the device demonstrate a non-pyrogenic response.	Data not available	Different

DISCUSSION OF DIFFERENCES:

Different: The color of the proposed device is violet blue whereas predicate device is blue. The color variation of the proposed device and predicate devices doesn't affect the safety and efficiency of the device.

The Performance Tests and Biocompatibility Tests demonstrated that AT Nitrile Examination Glove Powder Free met all acceptance criteria and has the similar indications for use, design, materials, technical characteristics and performance properties as compared to the predicate device. No new safety or effectiveness issues were raised during the testing program and therefore, this device may be considered substantially equivalent to the predicate device.

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows a logo with the letters 'AT' in a stylized design. The 'A' is colored with a gradient from red to black, and it has an arched shape. The 'T' is black and has three diagonal lines at the top right. The logo has a modern and corporate feel.

PERFORMANCE DATA VII.

A. Non- Clinical Data

Performance Tests

AT Nitrile Examination Glove 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

Table 2: Performance Testing Summary

	Tests	Proposed DeviceActual Data		Acceptance Criteria		Result
		Size	Length	Width	Size		Length	Width
1.	DimensionLength, Width and Thickness	S	247.76 mm	84.84 mm	S	230 mm	80±10 mm
		M	249.53 mm	94.46 mm	M		95±10 mm
		L	253.46 mm	105 mm	L		110±10 mm
		XL	243.53 mm	113.15 mm	XL		120±10 mm

	ASTM D6319-19Standard Specification forNitrile Examination Gloves forMedical Application	Thickness			Thickness
		Size	Palm	Finger	Size	Palm	Finger
		S	0.06 mm	0.09 mm	S
		M	0.06 mm	0.09 mm	M	0.05 mm	0.05 mm
		L	0.07 mm	0.10 mm	L
		XL	0.06 mm	0.09 mm	XL
		Tensile Strength			Tensile Strength
		Size	BeforeAging	AfterAging	Size	BeforeAging	AfterAging
2.	Physical propertyTensile strength andUltimate Elongation	S	31.57 MPa	29.38 MPa	S
		M	27.33 MPa	29.92 MPa	M	14 MPa	14 MPa
		L	30.58 MPa	29.91 MPa	L
		XL	28.06 MPa	30.40 MPa	XL

	ASTM D6319-19Standard Specification forNitrile Examination Gloves forMedical Application	Ultimate Elongation			Ultimate Elongation
		Size	BeforeAging	Afteraging	Size	BeforeAging	Afteraging
		S	534.61%	544.61%	S
		M	561.53%	550.76%	M
		L	521.53%	499.23%	L	500%	400%
		XL	546.15%	517.69%	XL

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image shows a logo with the letters 'AT' in a stylized design. The 'A' is in red and transitions to black, forming an arch shape. The 'T' is in black and has three diagonal lines above it on the right side. The logo has a modern and corporate feel.

Barrier property testsDetection of Holes inMedical Gloves	SM		SM
3.ASTM D6319-19 /ASTM D5151-19Standard Test Method forDetection of Holes in MedicalGloves		AQL 2.5		AQL 2.5	Pass
	XL		XL
	Size	Residual Powder Content	Size	Residual Powder Content
4.Powder Free ResidueASTM D6124-06(Reapproved 2017)Standard Test Method forResidual Powder on MedicalGloves	S	0.22 mg/glove	S
	M	0.36 mg/glove	M	≤2 Mg/glove	Pass
	L	0.10 mg/glove	L

B. Biocompatibility

The materials used in the AT Nitrile Examination Glove 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.

SI.No	Test Performed	Standard	Proposed Device	Result
1.	In Vitro Cytotoxicity	ISO 10993-5:2009	Underthe conditions of thestudy, cytotoxic. Additional Testingwas performed to determine if thiswas a systemic toxicity concern.	Pass
2.	Skin Sensitization	ISO 10993-10:2010	Under the conditions of the study not asensitizer	Pass
3.	Skin Irritation	ISO 10993-10:2010	Under the condition of study not anirritant.	Pass
4.	Acute systemic Toxicity	ISO 10993-11:2017	Under the condition of study, thedevice extracts do not pose a systemictoxicity concern	Pass
5.	MaterialMediatedPyrogenicity	ISO 10993-11:2017	Under the conditions of the study, thedevice demonstrate a non-pyrogenicresponse.	Pass

Table 3: Biocompatibility Test Summary

{8}------------------------------------------------

Image /page/8/Picture/0 description: The image shows a logo with the letters 'AT' in a stylized design. The 'A' is represented by a red arc that fades from dark to light, while the 'T' is in black with three vertical lines on the right side. The logo has a modern and corporate feel.

C. Clinical Test Data

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

VIII. CONCLUSION

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