A Powder free Nitrile Examination Gloves 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

ATM® Glove Powder free Nitrile Examination gloves 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

Here's an analysis of the provided text regarding the acceptance criteria and study for the ATM® Glove Powder free Nitrile Examination gloves, formatted to address your specific questions.

Device Under Review:
ATM® Glove Powder free Nitrile Examination gloves

Study Type: This document describes a 510(k) submission, demonstrating substantial equivalence to a predicate device for medical gloves. As such, the "study" is a series of non-clinical performance and biocompatibility tests rather than a clinical trial involving human patients or complex AI algorithms.

1. Table of Acceptance Criteria and Reported Device Performance

Context: The acceptance criteria for these examination gloves are based on established ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards. The reported performance demonstrates compliance with these criteria.

Test Category	Specific Test / Parameter	Acceptance Criteria	Reported Device Performance (ATM® Glove)	Pass/Fail
Dimensions (ASTM D6319-19)	Length (all sizes)	230mm min	S: 245mm, M: 247mm, L: 247mm, XL: 244mm	Pass
	Width (S)	80mm ±10	85mm	Pass
	Width (M)	95mm ±10	94mm	Pass
	Width (L)	110mm ±10	106mm	Pass
	Width (XL)	120mm ±10	112mm	Pass
	Thickness - Palm (all sizes)	0.05 mm min	S: 0.07 mm, M: 0.07 mm, L: 0.06 mm, XL: 0.07 mm	Pass
	Thickness - Finger (all sizes)	0.05 mm min	S: 0.11 mm, M: 0.12 mm, L: 0.11 mm, XL: 0.11 mm	Pass
Physical Properties (ASTM D6319-19)	Tensile Strength - Before Aging (all sizes)	14 Mpa Min (for all sizes)	S: 19.9 Mpa, M: 25.6 Mpa, L: 21.0 Mpa, XL: 23.1 Mpa	Pass
	Tensile Strength - After Aging (all sizes)	14 Mpa Min (for all sizes)	S: 18.9 Mpa, M: 27.7 Mpa, L: 20.5 Mpa, XL: 22.4 Mpa	Pass
	Ultimate Elongation - Before Aging (all sizes)	500% Min (for all sizes)	S: 518%, M: 517%, L: 558% (XL data not explicitly provided but implied pass)	Pass
	Ultimate Elongation - After Aging (all sizes)	400% Min (for all sizes)	S: 472%, M: 452%, L: 547% (XL data not explicitly provided but implied pass)	Pass
Barrier Property	Detection of Holes (AQL 2.5) (ASTM D6319-19 / ASTM D5151-19)	Passes AQL 2.5 (for all sizes)	AQL 2.5 (for S, M, L, XL)	Pass
Powder Residue (ASTM D6124-06)	Residual Powder Content	≤2 Mg/Glove Max (for all sizes)	S: 0.36 mg/glove, M: 0.16 mg/glove, L: 0.10 mg/glove, XL: 0.40 mg/glove	Pass
Biocompatibility (ISO 10993 Series)	In Vitro Cytotoxicity (ISO 10993-5:2009)	Non-cytotoxic to L-929 cells	Non-cytotoxic to L-929 cells	Pass
	Skin Sensitization (ISO 10993-10:2010)	Not a sensitizer	Not a sensitizer	Pass
	Skin Irritation (ISO 10993-10:2010)	Not an irritant	Not an irritant	Pass
	Acute Systemic Toxicity (ISO 10993-11:2017)	Device extracts do not pose a systemic toxicity concern	Device extracts do not pose a systemic toxicity concern	Pass
	Material-Mediated Pyrogenicity (ISO 10993-11:2017, USP 43 <151>)	Device did not demonstrate a material mediated pyrogenicity response	Device did not demonstrate a material mediated pyrogenicity response	Pass

2. Sample Sizes Used for the Test Set and Data Provenance

Sample Size for Test Set: The document does not explicitly state the exact sample sizes (e.g., number of gloves tested for each parameter) for the performance and biocompatibility tests. However, it indicates that the tests were performed "according to the requirements of Guidance for Industry and FDA Staff - Medical Glove Guidance Manual" and specific ASTM/ISO standards, which typically prescribe minimum sample sizes for statistical validity.
Data Provenance:
- Country of Origin of the Data: The testing was conducted for PHU DUC HUY PRODUCTION TRADING SERVICES CORPORATION, located in Vietnam. The test data would originate from the facility where these tests were performed, presumably in Vietnam or a certified lab commissioned by the manufacturer.
- Retrospective or Prospective: The testing described is clearly prospective as it's part of a premarket notification (510(k)) to demonstrate the new device's conformity to standards.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not Applicable: For medical gloves, "ground truth" is established by adherence to established, international consensus standards (ASTM, ISO). These standards define the test methodologies and acceptance criteria, rather than relying on human expert consensus for individual test outcomes (e.g., a radiologist for image interpretation). The "experts" involved are those who designed and validate these standards, and those performing the laboratory tests according to certified procedures.

4. Adjudication Method for the Test Set

Not Applicable: No human "adjudication" (like 2+1 or 3+1 consensus) is performed for these physical and biocompatibility tests. The outcome of each test is a measurable result (e.g., tensile strength in Mpa, AQL score, presence/absence of cytotoxicity) that is then compared against predefined numerical or categorical acceptance criteria from recognized standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No: An MRMC comparative effectiveness study is designed to evaluate the performance of diagnostic devices, especially those involving human interpretation, sometimes aided by AI. This is not relevant for the evaluation of medical gloves, which are physical barrier devices.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not Applicable: This device is a physical medical glove and does not involve any algorithms, AI, or software, hence no standalone (algorithm-only) performance testing was conducted.

7. The Type of Ground Truth Used

Standardized Test Methods and Predefined Acceptance Criteria: The "ground truth" for the device's performance is the adherence to the requirements outlined in internationally recognized standards such as 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). These standards set the benchmarks for physical properties, barrier integrity, and biocompatibility.

8. The Sample Size for the Training Set

Not Applicable: Medical gloves do not involve "training sets" in the context of machine learning or AI. The product is manufactured and then tested against established quality controls.

9. How the Ground Truth for the Training Set Was Established

Not Applicable: As there is no training set for an AI/ML model for this device, there is no ground truth established in that context.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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.

December 28, 2021

Phu Duc Huy Production Trading Services Corporation % Manoj Zacharias US Agent Liberty Management Group Limited 75 Executive Drive, Suite 114 Aurora, Illinois 60504, USA

Re: K213016

Trade/Device Name: ATM® Glove Powder free Nitrile Examination gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: August 10, 2021 Received: September 20, 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

{1}------------------------------------------------

statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

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

Sincerely,

For Clarence W. Murray, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known) K213016

Device Name

ATM® Glove Powder free Nitrile Examination Gloves

Indications for Use (Describe)

A Powder free Nitrile Examination Gloves 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)

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}------------------------------------------------

510(k) SUMMARY (K213016)

[AS REQUIRED BY 21CFR807.92]

I. SUBMITTER

II'

510(k) Owner's Name	PHU DUC HUY PRODUCTION TRADING SERVICES CORPORATION
Address	Hamlet 8, Luong Hoa Commune, Ben Luc District, Long An, 82000,Vietnam.
Contact person	Tran Xuan Kiem
Designation	CEO
Contact Number	84-91-3134359
Contact Email	Daingan6868jsc@Gmail.Com
Date of Summary Prepared	08/18/2021
DEVICE
Device Name	ATM® Glove Powder free Nitrile Examination gloves
Device Common Name	Powder free Nitrile Examination glove
Device Classification name	Non-powdered patient examination glove
Regulation Number	21 CFR 880.6250
Class	I
Product Code	LZA

Page 1 of 6

Office: Hamlet 8, Luong Hoa Commune, Ben Luc District, Long An Province

9 Factory: Lot A3.6, Road No 8, Chon Thanh I Industry Park, Thanh Tam Commune, Chon Thanh District, Binh Phuoc Province, Vietnam.
% www.atmmedical.vn
മ atmgloves@gmail.com
(+84) 928392839 VN
0 +1 (877) 272 6688 USA

PHU DUC HUY Productic Service Corperation

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

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

IV. DEVICE DESCRIPTION

V. INTENDED USE

A Powder free Nitrile Examination gloves 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	K213016	K192333	-
2.	Manufacturer	PHU DUC HUY PRODUCTIONTRADING SERVICESCORPORATION	JR Engineering & MedicalTechnologies (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	ATM® Glove Powder free NitrileExamination gloves is adisposable device intended formedical purpose that is worn onthe examiner's hand to preventcontamination between patientand examiner.	JR MEDIC Blue NitrileExamination Gloves Powder Freeis disposable devices intended formedical purpose that are worn onthe examiner's hand to preventcontamination between patientand examiner.	Same
SI.No	Features compared	Proposed Device	Predicate Device	Result
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, XL	XS, S, M, L, XL	Different
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 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 1.5	Similar
19.	Powder Free Residue	≤2 mg/glove	≤2 mg/glove	Same
20.	Biocompatibility Study	In vitro Cytotoxicity	Under the conditions of the studyNon-Cytotoxic to L-929 cells	Under the conditions of thestudy, cytotoxic.	Different
		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.	Under the condition of study, thedevice extracts do not pose asystemic toxicity.	Same
		Material mediatedpyrogenicity	Under the conditions of the study,the device did not demonstrate amaterial mediated Pyrogenicityresponse.	Under the conditions of the study,the device did not demonstrate amaterial mediated Pyrogenicityresponse.	Same

Table 1: General Comparison

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

There are no significant differences between the two products and are identical in terms of intended use, materials, design, manufacturing methods. Both devices met the performance standards.

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

VII. PERFORMANCE DATA

A. Non- Clinical Data

Performance Tests

ATM® Glove Powder free Nitrile Examination gloves 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

SINo.	Tests	Proposed Device actualData			Acceptance Criteria			Result
1.		Size	Length	Width	Size	Length	Width
	DimensionLength, Width andThicknessASTM D6319-19Standard Specification forNitrile Examination Glovesfor Medical Application	S	245 mm	85 mm	S	230mm min	80mm ±10	Pass
		M	247 mm	94 mm	M		95mm ±10
		L	247 mm	106 mm	L		110mm ±10
		XL	244 mm	112 mm	XL		120mm ±10
		Thickness				Thickness
		Size	Palm	Finger	Size	Palm	Finger
		S	0.07 mm	0.11 mm	S	0.05 mm min	0.05 mm min
		M	0.07 mm	0.12 mm	M
		L	0.06 mm	0.11 mm	L
		XL	0.07 mm	0.11 mm	XL
2.		Tensile strength			Tensile strength
		Size	BeforeAging	AfterAging	Size	BeforeAging	AfterAging
	Physical propertyTensile strength andUltimate ElongationASTM D6319-19Standard Specification forNitrile Examination Glovesfor Medical Application	S	19.9Mpa	18.9Mpa	S			Pass
		M	25.6Mpa	27.7Mpa	M	14Mpa Minfor all sizes	14Mpa Min forall sizes
		L	21.0Mpa	20.5Mpa	L
		XL	23.1Mpa	22.4Mpa	XL
		Ultimate Elongation			Ultimate Elongation
		Size	BeforeAging	AfterAging	Size	BeforeAging	AfterAging
		S	518%	472%	S
		M	517%	452%	M	500% Min forall sizes	400%Min forall sizes
		L	558%	547%	L

Table 2: Performance Testing Summary

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

SI No.	Tests	Proposed Device actual Data	Acceptance Criteria	Result
3.	Barrier property testsDetection of Holes inMedical GlovesASTM D6319-19 /ASTMD5151-19Standard Test Method forDetection of Holes in MedicalGloves	SMLXL	Passes AQL 2.5Passes AQL 2.5Passes AQL 2.5Passes AQL 2.5	AQL 2.5	Pass
4.	Powder Free ResidueASTM D6124-06(Reapproved 2017)Standard Test Method forResidual Powder on MedicalGloves	Size	Residual powder content	Size	Residual powder content
		SMLXL	0.36 mg/glove0.16 mg/glove0.10 mg/glove0.40 mg/glove	SMLXL	≤2 Mg/Glove Max

B. Biocompatibility

The materials used in the ATM® Glove Powder free Nitrile Examination gloves 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 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	Standard	Proposed Device	Result
1.	In Vitro Cytotoxicity	ISO 10993-5:2009	Under the conditions of thestudy, Non-cytotoxic to L-929 cells.	Pass
2.	Skin Sensitization	ISO 10993-10:2010	Under the conditions of thestudy not a sensitizer	Pass
3.	Skin Irritation	ISO 10993-10:2010	Under the condition of studynot an irritant	Pass

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

4.	Acute Systemic Toxicity	ISO 10993-11:2017	Under the condition of study,the device extracts do notpose a systemic toxicityconcern	Pass
5.	Material-MediatedPyrogenicity	ISO 10993-11:2017USP 43 <151> Pyrogen Test,2020.	Under the conditions ofthe study, the device did notdemonstrate amaterial mediatedpyrogenicity response.	Pass

Clinical Test Data C.

Clinical study was not conducted as clinical data is not needed for ATM® Glove Powder free Nitrile Examination glove.

VIII. CONCLUSION

The conclusion drawn from the non-clinical tests demonstrate that the subject device, ATM® Glove Powder free Nitrile Examination gloves are as safe, as effective and perform as well as or better than legally marketed predicated device in K192333.

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.