K Number

Device Name

Disposable Powder Free Nitrile Examination Glove, Pink/Black Color

Manufacturer

Ever Growth (Vietnam) Co. Ltd.

Date Cleared

2020-01-07

(272 days)

Product Code

LZA

Regulation Number

880.6250

Intended Use

The Nitrile Powder Free patient examination glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

Device Description

"Disposable Powder Free Nitrile Examination Glove, Pink Color" and "Disposable Powder Free Nitrile Examination Glove, Black Color" are patient examination gloves made from nitrile compound, non-sterile (as per 21 CFR 880.6250, Class I). The principle operation of the medical device to provide single use barrier protection for the wearer and the device meets all the requirement specifications for Barrier Protection, tensile properties as defined in ASTM D6319-10, Standard specification for Nitrile Examination Gloves.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K172642

Reference Devices

K172642

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical properties and barrier protection of examination gloves, with no mention of AI or ML.

Therapeutic

No
The device is described as a patient examination glove, intended to act as a barrier to prevent contamination, not to provide therapy.

Diagnostic

No.
The device is a non-sterile disposable examination glove intended for barrier protection, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

The device is a physical examination glove made of nitrile, which is a hardware component. The description focuses on material properties and physical performance testing, not software functionality.

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 to prevent contamination between patient and examiner by providing a barrier on the examiner's hands. This is a physical barrier function, not a diagnostic test performed on a sample from the human body.
Device Description: The description focuses on the material (nitrile), physical properties (tensile strength, elongation), and barrier function (water leak test). These are characteristics of a physical barrier device, not a diagnostic device.
Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's condition.
Regulatory Classification: The device is classified under 21 CFR 880.6250, which is for Patient Examination Gloves. This regulation specifically covers gloves used for medical examinations and procedures to prevent contamination, not for in vitro diagnostic testing.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device does not perform any such function.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

LZA

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

hands or finger

Indicated Patient Age Range

Not Found

Intended User / Care Setting

examiner

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)

The following bench testing was conducted for design elements and performance characteristics deemed appropriate to demonstrate equivalence to the predicate device, Orange Non Sterile Powder Free Nitrile Examination Gloves made by Central Medicare Sdn Bhd. The subject device "Disposable Powder Free Nitrile Examination Glove, Pink Color" and "Disposable Powder Free Nitrile Examination Glove, Black Color" met with the acceptance criteria ensuring substantial equivalence to the predicate device. No new safety or performance issues were raised during testing:

Dimension per ASTM D6319-10 (Reapproved 2015)
A Tensile strength(Before aging/After aging) and Elongation(Before aging/After aging) per ASTM D6319-10(Reapproved 2015)
A Water leak test on pinhole per ASTM D6319-10(Reapproved 2015) and per 21 CFR 800.20.
Powder Residual tests per ASTM D6319-10(Reapproved 2015)
Biocompatibility test per ISO 10993-10: Third Edition 2010-08-01 and ISO 10993-5: Third Edition 2009-06

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K172642

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

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

Ever Growth (Vietnam) Co. Ltd. % Elizabeth Deng U.S. Representative Elizabeth Deng 5748 Eaglewood Place, Rancho Cucamonga Rancho Cucamonga, California 91730

Re: K190942

Trade/Device Name: Disposable Powder Free Nitrile Examination Glove, Pink/Black Color Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZA Dated: October 10, 2019 Received: October 10, 2019

Dear Elizabeth Deng:

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

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 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 Elizabeth Claverie, M.S. 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K190942

Device Name

Disposable Powder Free Nitrile Examination Glove, Pink Color

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

_ 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."

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K190942

Device Name

Disposable Powder Free Nitrile Examination Glove, Black Color

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

_ 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.

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."

510(k) Summary K190942

1.0 Submitter:

	Submitter's name :	Ever Growth (Vietnam) Co., Ltd.
	Submitter's address :	Long Khanh Industrial Zone, Binh Loc Ward, Long Khanh Township, Dong Nai,
Vietnam
	Phone number :	84-61-3514025
	Fax number :	84 -61-3514023
	Name of contact person:	Ming Lee
	Summary Preparation Date:	Dec. 9th, 2019
2.0	US Agent:
	US representative name	Elizabeth Deng
	Company address	5748 Eaglewood Place
Rancho Cucamonga, California
Rancho Cucamonga, CA 91739
	Telephone number	909 4659188
	Contact email	Baxianunited48@Yahoo.Com
	3.0 Name of the Device
	Proprietary/Trade name:	Disposable Powder Free Nitrile Examination Glove, Pink Color
Disposable Powder Free Nitrile Examination Glove, Black Color
	Common Name:	Nitrile Examination Gloves
	510(k) Number	K190942
	Classification Name:	Patient Examination Glove
	Device Classification:	Class I
	Regulation Number:	21 CFR 880.6250
	Product Code:	LZA
	4.0 Predicate device
	Device Name:	Orange Non Sterile Powder Free Nitrile Examination Gloves
	Company name:	Central Medicare Sdn. Bhd.
	510(K) Number:	K172642

5.0 Device Description:

6.0 Indications for Use:

The Nitrile Powder Free patient examination glove is a non-sterile disposable device intended for medical purposes

that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

7.0 Summary of the Technological Characteristics of the Device:

"Disposable Powder Free Nitrile Examination Glove, Pink Color" and "Disposable Powder Free Nitrile Examination Glove, Black Color" are summarized with the following technological characteristics compared to ASTM or equivalent standard.

Table 7.1 Summary of the Technological Characteristics
--------------------------------------------------------	--	--	--

Characteristics	Standard
Dimension	ASTM standard D 6319-10(Reapproved 2015)
	Length ≥230mm
	Width
X Small 70 $\pm$ 10 mm
Small 80 $\pm$ 10 mm
Medium 95 $\pm$ 10 mm
Large 110 $\pm$ 10 mm
X large 120 $\pm$ 10 mm

	Thickness	Finger tip	≥0.05mm
		Palm	≥0.05mm
Physical Properties	ASTM standard D 6319-10(Reapproved 2015)
	Tensile strength (Before aging)		≥14MPa
	Tensile strength (After aging)		≥14MPa
	Elongated rate (Before aging)		≥500%
	Elongated rate (After aging)		≥400%
Freedom from pinholes	21 CFR 800.20		Passed Standard Acceptance Criteria
		ASTM standard D 6319-10(Reapproved 2015)
		Test method in accordance with ASTM D5151-
06(Reapproved 2015)
Powder Residual		ASTM standard D6319-10(Reapproved 2015)
Test method in accordance with D6124-
06(Reaffirmation 2011)

A Tensile strength(Before aging/After aging) and Elongation(Before aging/After aging) per ASTM D6319-10(Reapproved 2015)
A Water leak test on pinhole per ASTM D6319-10(Reapproved 2015) and per 21 CFR 800.20.
Powder Residual tests per ASTM D6319-10(Reapproved 2015)
Biocompatibility test per ISO 10993-10: Third Edition 2010-08-01 and ISO 10993-5: Third Edition 2009-06

9.0 Based on Assessment of Clinical Performance Data:

Clinical data was not needed to demonstrate that the subject glove is substantially equivalent to the predicate glove. So determination of substantial equivalence is not based on an assessment of clinical performance data.

10.0 Substantial Equivalence Comparison:

| Device

Characteristic	Predicate Device	Proposed Device	Comparison
Product name	Orange Non Sterile Powder Free Nitrile
Examination Gloves	Disposable Powder Free Nitrile Examination
Glove, Pink Color
Disposable Powder Free Nitrile Examination
Glove, Black Color	N/A
510(K) No.	K172642	K190942	N/A
Product Owner	Central Medicare Sdn. Bhd.	Ever Growth Enterprise Corporation	Different
Product Code	LZA	LZA	same
Regulation	21 CFR 880.6250	21 CFR 880.6250	same
Class	I	I	same
Intended Use	Orange Non Sterile Powder Free Nitrile
Examination Gloves is a disposable device	The Nitrile Powder Free patient examination
glove is a non-sterile disposable device	similar
	intended for medical purposes that is worn
on the examiner's hands to prevent
contamination between patient and
examiner.	intended for medical purposes that is worn
on the examiner's hands or finger to
prevent contamination between patient and
examiner.
Power free	Yes	Yes	same
Size	X Small/ Small/ Medium/Large/X Large	X Small/ Small/ Medium/Large/X Large	similar
Single Use	YES	YES	same
Non-Sterile	YES	YES	same
Dimensions-
Length	Complies with ASTM D6319-10
230 mm min.	Complies with ASTM D6319-10
230 mm min.	same
Dimensions -
Palm Width	Complies with ASTM D6319-10
X Small
70±10	Complies with ASTM D6319-10
X Small
70±10	similar
	Small
80 ±10	Small
80 ±10
	Medium
95±10	Medium
95±10
	Large
110 ±10	Large
110 ±10
	X large
120 ±10	X large
120 ±10
Dimensions -
Thickness	Complies with ASTM D6319-10
Palm - 0.05mm min.
Finger - 0.05 mm min.	Complies with ASTM D6319-10
Palm - 0.05mm min.
Finger - 0.05 mm min.	Same
Physical
Properties	Tensile Strength:
Before Aging 14 MPa, min.
After Aging 14 MPa, min.

Elongation:
Before Aging 500% min.
After Aging 400% min. | Tensile Strength:
Before Aging 14 MPa, min.
After Aging 14 MPa, min.