Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

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

Therapeutic

No.
The device description and intended use indicate it is an examination glove used to prevent contamination, not to treat or diagnose a disease or condition.

Diagnostic

No
Explanation: The device is a patient examination glove, intended to prevent contamination between patient and examiner, not to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device is a physical examination glove, 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 device is a "patient examination glove" worn on the hands or fingers to prevent contamination. This is a physical barrier device, not a device used to examine specimens in vitro (outside the body).
Device Description: The description focuses on meeting ASTM standards for examination gloves, which are related to physical properties and performance as a barrier.
Lack of IVD Characteristics: There is no mention of analyzing biological specimens, reagents, calibrators, controls, or any other components typically associated with IVD devices.

Therefore, this device falls under the category of a medical device, but not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or fingers to prevent contamination between patient and examiner.

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

LZA

Device Description

The Powder Free Nitrile (Black) Examination Gloves meets all the requirements of ASTM Specification D6319-10 -Standard Specification for Nitrile Examination Gloves for Medical Application.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Hands or fingers of the examiner

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Examiner (medical purposes)

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 device was tested against the following standards and requirements:

Dimensions: Meets ASTM D6319-10 Standard requirements, Minimal value for Length: 242 mm, Minimal value for Width: 94mm
Physical Properties (Tensile Strength): Before Aging: Minimal Value: 24.74 MPa, After Accelerated Aging: Minimal Value: 31.67 MPa. Meets ASTM D6319-10 Standard requirements.
Physical Properties (Ultimate Elongation): Before Aging Minimal Value: 528%, After Aging Minimal Value: 439%. Meets ASTM D6319-10 Standard requirements.
Thickness: Palm - min. 0.09mm, Finger - min. 0.13mm. Meets standard requirements.
Biocompatibility: Under the condition of the Study - Not an irritant (ISO 10993-10:2010), Under the condition of the Study - Not a sensitizer (ISO 10993-10:2010).
Freedom from Pinholes: Passes AQL 2.5. Meets 21 CFR 800.20 and ASTM D5151 – 06 Standard Requirements.
Powder Residual: Minimal Value: 0.32 mg. Meets ASTM D6124-06 Standard requirements.

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.

K123116

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/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized image of three faces in profile, stacked on top of each other. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the image.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 9, 2015

Gallant Quality SDN. BHD. Ms. Sumathi Saravana Sami Assistant QA Manager Lot 1874. Jalan Kampung Dew 34700 Taiping, Perak MALAYSIA

Re: K151528

Trade/Device Name: Powder Free Nitrile (Black) Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Regulatory Class: I Product Code: LZA Dated: September 3, 2015 Received: September 9, 2015

Dear Ms. Sumathi Saravana Sami:

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. 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.

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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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiologic Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K151528

Device Name

Powder Free Nitrile (Black) Examination Gloves

Indications for Use (Describe)

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or fingers 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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510(k) SUMMARY K151528

1.0 Submitter :

Name	: Gallant Quality Sdn. Bhd.
Address	: Lot 1874, Jalan Kampung Dew,
34700 Taiping, Perak,
Malaysia
Phone No.	: 605-847 2777
Fax No .	: 605-847 9108

Contact Person : Sumathi Saravana Sami (Ms) : sumathisaravana@comfort-rubber.com.my Email 28 September 2015 Date of Preparation:

2.0 Name of the Device

Powder Free Nitrile (Black) Examination Gloves

Common Name	Nitrile Exam Gloves
Classification Name	Patient Examination Gloves (21 CFR 880.6250)
Product Code	LZA

3.0 Identification of The Legally Marketed Devices That equivalency is claimed:

Primary Predicate:

Chlorinated Powder Free Nitrile Examination Gloves (Black Colour) Company: Worldmed Manufacturing Sdn. Bhd. 510(k): K123116 Regulatory Class I Product Code: LZA

4.0 Description of the Device:

The Powder Free Nitrile (Black) Examination Gloves meets all the requirements of ASTM Specification D6319-10 -Standard Specification for Nitrile Examination Gloves for Medical Application.

5.0 Intended Use of the Device

The Powder Free Nitrile (Black) Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hands or fingers to prevent contamination between patient and examiner.

6.0 Summary of the Technological Characteristics of the Device:

The Powder Free Nitrile (Black) Examination Gloves are summarized with the following technological characteristics and is substantially equivalent to the predicate device with regard to physical characteristics, design, product features, and intended use. Both gloves

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are made with nitrile and meets ASTM Specification D6319-10 - Standard Specification for Nitrile Examination Gloves for Medical Application or equivalent standards.

CHARACTERISTICS	STANDARDS	DEVICE PERFORMANCE
Dimensions	ASTM D6319-10:
Length - min. 230mm
Width - min. 95 ± 10mm	Meets ASTM D6319-10
Standard requirements
Minimal value for Length:
242 mm
Minimal value for Width: 94mm
Physical Properties	ASTM D6319-10:
Tensile Strength:
Before Aging: 14 MPa
After Aging: 14 MPA	Meets ASTM D6319-10
Standard requirements
Tensile Strength:
Before Aging: Minimal Value:
24.74 MPa
After Accelerated Aging:
Minimal Value: 31.67 MPa
	Ultimate Elongation:
Before Aging: min. 500%
After Aging: min. 400%	Ultimate Elongation:
Before Aging Minimal Value:
528%
After Aging Minimal Value:
439%
Thickness	ASTM D6319-10
Min 0.05mm	Meets standard requirements
Standard requirements
Palm - min. 0.09mm
Finger - min. 0.13mm
Biocompatibility	ISO 10993-10:2010
Biological evaluation of
medical devices – Part 10:
Tests for irritation and skin
sensitization	Under the condition of the
Study - Not an irritant
	ISO 10993-10:2010
Biological evaluation of
medical devices – Part 10:
Tests for irritation and skin
sensitization	Under the condition of the
Study - Not a sensitizer
Freedom from Pinholes	21 CFR 800.20; ASTM
D5151-06
AQL 2.5	Meets 21 CFR 800.20 and
ASTM D5151 – 06 Standard
Requirements
Passes AQL 2.5
Powder Residual	ASTM D6124-06:
$\le$ 2 mg/ glove	Meets ASTM D6124-06
Standard requirements
Minimal Value: 0.32 mg

7.0 Substantial Equivalent Based on Assessment of Non-Clinical Performance Data

The performance test data of non-clinical tests that support a determination of substantial equivalence is the same as described in section 6.0 above and meets ASTM standards, and FDA requirements for water leak test on pinhole AQL.

8.0 Substantial Equivalent Based on Assessment of Clinical Performance Data

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Not applicable - Clinical data is not needed for gloves or most devices cleared by the 510(k) process.

9.0 Substantial Equivalence Comparison

The Powder Free Nitrile (Black) Examination Gloves is substantially equivalent to the predicate device with respect to intended use, product features and the technological characteristics. The substantial equivalence comparison is presented in the table below:

| Characteristic
and
parameters | Worldmed
Manufacturing Sdn.
Bhd. K123116
(Predicate) | Powder Free Nitrile
(Black) Examination
Gloves
(Proposed) | Substantial
Equivalence
(SE) |
|-----------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|
| Product Code | LZA | LZA | SE |
| Intended use | Intended for medical
purposes that is worn on
the examiner's hands or
fingers to prevent
contamination between
patient and examiner. | Intended for medical
purposes that is worn on
the examiner's hands or
fingers to prevent
contamination between
patient and examiner. | SE |
| Indications for
Use Statement | The nitrile examination
glove is a disposable
device intended for
medical purpose that is
worn on the examiner's
hand or finger to prevent
contamination between
patient and examiner | The Powder Free Nitrile
(Black) Examination
Gloves is a disposable
device intended for
medical purposes that is
worn on the examiner's
hands or fingers to
prevent contamination
between patient and
examiner. | SE |
| Device Material | Nitrile Synthetic Latex | Nitrile Synthetic Latex | SE |
| Color | Black | Black | SE |
| Additives | No flavor additive | No flavor additive | SE |
| Instruction for
Use on Labeling | Single Use Only | Single Use Only | SE |
| Construction | Ambidextrous | Ambidextrous | SE |
| Sterility | Non-sterile | Non-sterile | SE |
| Acceptance
Criteria | ASTM D6319-10 | ASTM D6319-10 | SE |
| Device Tolerance & Specifications: | | | |
| Dimensions | Meets ASTM D 6319-10 | Meets ASTM D 6319-10
Overall Length – min. 230
mm

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10.0 Conclusion

The Powder Free Nitrile (Black) Examination Gloves meet all of the requirements of FDArecognized consensus standards: ASTM D6319-10, ASTM D5151-06, ASTM D6124-06 and ISO 10993-10:2010 and meet our labeling claims and pinhole acceptable quality level (AQL) as shown above.

There are no significant differences between the two products and are identical in terms of intended use, materials and performance.

The conclusion drawn from the nonclinical tests demonstrate that the device is as safe and as effective and performs as well as the legally marketed device.

Based on the comparison of intended use, design, device materials, performance and specification, the Powder Free Nitrile (Black) Examination Gloves are substantially equivalent to the predicate device.