Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a simple examination glove and the summary contains no mention of AI or ML technology.

Therapeutic

No
The document states that the device is "intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner," which describes a prevention function rather than a therapeutic one. It does not mention treating or alleviating a disease or condition.

Diagnostic

No
The device is described as an examination glove intended to prevent contamination between patient and examiner, not to diagnose a medical condition.

SaMD (Software as a Medical Device)

No

The device is a physical glove made of nitrile, not a software application.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the gloves are for preventing contamination between patient and examiner by being worn on the examiner's hand. This is a barrier function, not a diagnostic function.
Device Description: The description focuses on the material, specifications, and physical characteristics of the gloves. There is no mention of any components or processes related to analyzing samples from the human body (which is the core of IVD).
Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis, monitoring, or treatment decisions based on sample analysis.

The device is classified as a Class I medical device (product code LZA), which is consistent with examination gloves and not typically associated with IVDs.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes

LZA

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.

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

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

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.

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

Key Metrics

Not Found

Predicate Device(s)

K192333

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 880.6250 Non-powdered patient examination glove.

(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.

Summary

0

Image /page/0/Picture/0 description: The image 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)

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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

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.

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 PRODUCTION
TRADING SERVICES
CORPORATION	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	ATM® Glove 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.	JR MEDIC Blue Nitrile
Examination Gloves Powder Free
is disposable devices intended for
medical purpose that are worn on
the examiner's hand to prevent
contamination between patient
and 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 m
Width Min 95±10
Mm (for medium size)	Length Min 230 m
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	≤2 mg/glove	Same
20.	Biocompatibility Study	In vitro Cytotoxicity	Under the conditions of the study
Non-Cytotoxic to L-929 cells	Under the conditions of the
study, cytotoxic.	Different
		Skin Sensitization	Under the conditions of the study
not a sensitizer	Under the conditions of the study
not a sensitizer	Same
		Skin Irritation	Under the condition of study not
an irritant	Under the condition of study not
an irritant	Same
		Acute systemic
toxicity	Under the condition of study, the
device extracts do not pose a
systemic toxicity.	Under the condition of study, the
device extracts do not pose a
systemic toxicity.	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

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

| SI
No. | Tests | Proposed Device actual
Data | | | Acceptance Criteria | | | Result |
|-----------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|-----------------|----------------|---------------------|----------------------------|----------------------------|--------|
| 1. | | Size | Length | Width | Size | Length | Width | |
| | Dimension

Length, Width and
Thickness

ASTM D6319-19
Standard Specification for
Nitrile Examination Gloves
for 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 | Before
Aging | After
Aging | Size | Before
Aging | After
Aging | |
| | Physical property

Tensile strength and
Ultimate Elongation

ASTM D6319-19
Standard Specification for
Nitrile Examination Gloves
for Medical Application | S | 19.9Mpa | 18.9Mpa | S | | | Pass |
| | | M | 25.6Mpa | 27.7Mpa | M | 14Mpa Min
for all sizes | 14Mpa Min for
all sizes | |
| | | L | 21.0Mpa | 20.5Mpa | L | | | |
| | | XL | 23.1Mpa | 22.4Mpa | XL | | | |
| | | Ultimate Elongation | | | Ultimate Elongation | | | |
| | | Size | Before
Aging | After
Aging | Size | Before
Aging | After
Aging | |
| | | S | 518% | 472% | S | | | |
| | | M | 517% | 452% | M | 500% Min for
all sizes | 400%Min for
all sizes | |
| | | L | 558% | 547% | L | | | |

Table 2: Performance Testing Summary

7

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	S
M
L
XL	Passes AQL 2.5
Passes AQL 2.5
Passes AQL 2.5
Passes AQL 2.5	AQL 2.5	Pass
4.	Powder Free Residue
ASTM D6124-06
(Reapproved 2017)
Standard Test Method for
Residual Powder on Medical
Gloves	Size	Residual powder content	Size	Residual powder content
		S
M
L
XL	0.36 mg/glove
0.16 mg/glove
0.10 mg/glove
0.40 mg/glove	S
M
L
XL	≤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
1.	In Vitro Cytotoxicity	ISO 10993-5:2009	Under the conditions of the
study, Non-cytotoxic to L-
929 cells.	Pass
2.	Skin Sensitization	ISO 10993-10:2010	Under the conditions of the
study not a sensitizer	Pass
3.	Skin Irritation	ISO 10993-10:2010	Under the condition of study
not an irritant	Pass

8

| 4. | Acute Systemic Toxicity | ISO 10993-11:2017 | Under the condition of study,
the device extracts do not
pose a systemic toxicity
concern | Pass |
|----|-----------------------------------|----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|------|
| 5. | Material-Mediated
Pyrogenicity | ISO 10993-11:2017
USP 43 Pyrogen Test,
2020. | Under the conditions of
the study, the device did not
demonstrate a
material mediated
pyrogenicity 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.