Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a simple examination glove and the summary does not mention any AI or ML capabilities. The performance studies focus on physical properties and barrier integrity, not algorithmic performance.

Therapeutic

No.

The device is an examination glove, intended to prevent contamination between patient and examiner, not to provide therapy.

Diagnostic

No
The device is described as an examination glove intended to prevent contamination, not to diagnose a condition. The performance studies and key metrics are related to the physical properties, barrier integrity, and biocompatibility of the glove, not its ability to detect or identify a disease or condition.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical glove made from acrylonitrilebutadiene copolymer dispersion, intended to be worn on the hand. It is a hardware device, not software.

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 is "worn on the examiner's hand to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic function performed in vitro (outside the body).
Device Description: It's described as a "disposable device intended for medical purpose" and a "Class I device bearing the product code LZA (21CFR 880.6250)." The product code LZA is for "Glove, Examination, Patient." This classification and product code are for medical gloves, not IVD devices.
Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information.
Performance Studies: The performance studies focus on physical properties, barrier integrity, and biocompatibility, which are relevant to medical gloves, not IVD devices.

In summary, the AT Nitrile Examination Glove Powder Free is a medical device used as a barrier, not a device used for in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

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

LZA

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.

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
Physical property
Barrier property tests
Detection of Holes in Medical Gloves
Powder Free Residue
Key Results: All tests passed the acceptance criteria as defined by ASTM D6319-19 and ASTM D6124-06.

Biocompatibility Tests:

In Vitro Cytotoxicity
Skin Sensitization
Skin Irritation
Acute Systemic Toxicity
Material Mediated Pyrogenicity
Key Results: All tests passed and demonstrated non-cytotoxicity, non-sensitization, non-irritation, no systemic toxicity concern, and non-pyrogenic response according to ISO 10993-1:2018.

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

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.

K210276

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 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)

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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 Seramik
Chepor, 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

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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

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.

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 MEDICAL
MANAGEMENT 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	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.	The Disposable Nitrile Gloves 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	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

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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 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 2.5	Same
19.	Powder Free Residue	≤2 mg/glove	≤2 mg/glove	Same
20.	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, non-cytotoxic.	Same
		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.	Data not available	Different
		Material Mediated
Pyrogenicity	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.

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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 Actual Data | | Acceptance Criteria | | Result | |----|------------------------------------------------------------------------------------------------------|-- | | | Size | 1. | Dimension
Length, Width and Thickness | S | | | M | | | L | | | XL | | | | | ASTM D6319-19
Standard Specification for
Nitrile Examination Gloves for
Medical Application | Thickness | | | Thickness | | | Size | | | S | | | M | | | L | | | XL | | | | | Size Aging | After
Aging | Size | Before
Aging | After
Aging | |
| 2. | Physical property
Tensile strength and
Ultimate Elongation | S | 31.57 MPa | 29.38 MPa | | | M | | | L | | | XL | | | | | ASTM D6319-19
Standard Specification for
Nitrile Examination Gloves for
Medical Application | Ultimate Elongation | | | Ultimate Elongation | | | | Size Aging | After
aging | Size | Before
Aging | After
aging | |
| | | S | | | M | | | L | | | XL | Proposed Device
| |
------------------------------|-----------------|---------------------|---------------------|-----------------|----------------|-------|
| Length | Width | Size | | Length | Width |
| 247.76 mm | 84.84 mm | S | 230 mm | 80±10 mm | |
| 249.53 mm | 94.46 mm | M | | 95±10 mm | |
| 253.46 mm | 105 mm | L | | 110±10 mm | |
| 243.53 mm | 113.15 mm | XL | | 120±10 mm | |
| | | | | | |
| | | |
| Palm | Finger | Size | Palm | Finger | |
| 0.06 mm | 0.09 mm | S | | | |
| 0.06 mm | 0.09 mm | M | 0.05 mm | 0.05 mm | |
| 0.07 mm | 0.10 mm | L | | | |
| 0.06 mm | 0.09 mm | XL | | | |
| Tensile Strength | | | Tensile Strength | | | |
| Before
| S | | | |
| 27.33 MPa | 29.92 MPa | M | 14 MPa | 14 MPa | |
| 30.58 MPa | 29.91 MPa | L | | | |
| 28.06 MPa | 30.40 MPa | XL | | | |
| | | | | | |
| | |
| Before
| 534.61% | 544.61% | S | | | |
| 561.53% | 550.76% | M | | | |
| 521.53% | 499.23% | L | 500% | 400% | |
| 546.15% | 517.69% | XL | | | |

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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 tests
Detection of Holes in
Medical Gloves | S
M | | S
M | | |
|-------------------------------------------------------------------------------------------------------------------------------------|--------|-------------------------|--------|-------------------------|------|
| 3.
ASTM D6319-19 /ASTM D5151-
19
Standard Test Method for
Detection of Holes in Medical
Gloves | | AQL 2.5 | | AQL 2.5 | Pass |
| | XL | | XL | | |
| | Size | Residual Powder Content | Size | Residual Powder Content | |
| 4.
Powder Free Residue
ASTM D6124-06
(Reapproved 2017)
Standard Test Method for
Residual Powder on Medical
Gloves | 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
1.	In Vitro Cytotoxicity	ISO 10993-5:2009	Under
the conditions of the
study, cytotoxic. Additional Testing
was performed to determine if this
was a systemic toxicity concern.	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
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	Under the conditions of the study, the
device demonstrate a non-pyrogenic
response.	Pass

Table 3: Biocompatibility Test Summary

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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