Orange Non Sterile Powder Free Nitrile Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Device Description

Orange Non Sterile Powder Free Nitrile Examination are Class I Patient Examination Gloves. They are ambidextrous, and come in different sizes - Extra Small, Small, Medium, Large and Extra Large. Gloves meet the specification of ASTM D6319-10 and follows the FDA Medical Glove Guidance Manual.

AI/ML Overview

This document describes the acceptance criteria and the study proving that "Orange Non Sterile Powder Free Nitrile Examination Gloves" meets these criteria.

Acceptance Criteria and Reported Device Performance

The device, "Orange Non Sterile Powder Free Nitrile Examination Gloves," demonstrates substantial equivalence to its predicate device (K143247) by meeting the following acceptance criteria based on established ASTM standards and FDA guidance:

Criteria	Acceptance Threshold (ASTM D6319-10 unless specified)	Proposed Device Performance	Remarks
Physical Properties
Before Aging
Tensile Strength	15 MPa min	15 MPa min	Meets acceptance criteria and is same as predicate.
Ultimate Elongation	500% min	500% min	Meets acceptance criteria and is same as predicate.
After Aging
Tensile Strength	14 MPa min	14 MPa min	Meets acceptance criteria and is same as predicate.
Ultimate Elongation	400% min	400% min	Meets acceptance criteria and is same as predicate.
Freedom from Holes	In accordance with ASTM D5151-06, AQL 2.5/Inspection Level G-I	In accordance with ASTM D5151-06, AQL 2.5/Inspection Level G-I	Meets acceptance criteria and is similar to predicate.
Powder Content	Max. 0.50 mg per glove	Max. 0.50 mg per glove	Meets acceptance criteria. Predicate had 0.40mg/glove, but both meet the specified maximum.
Biocompatibility	Not an irritant	Not an irritant	Meets acceptance criteria.
Irritation	Not a sensitizer	Not a sensitizer	Meets acceptance criteria.
Sensitization
Dimensions	(ASTM D6319-10)
Length	Minimum 230 mm	Minimum 230 mm (for all sizes)	Meets acceptance criteria and is same as predicate.
Width (XS, S, M, L, XL)	70, 80, 95, 110, 120 mm (±0.10)	70, 80, 95, 110, 120 mm (±0.10)	Meets acceptance criteria and is same as predicate.
Thickness	(Palm/Finger) - Not specified numerically but referred to ASTM D6319-10	(Palm/Finger) - Not specified numerically but referred to ASTM D6319-10	Meets referenced standard.

Study Details

The provided document describes a non-clinical performance study to demonstrate substantial equivalence, rather than a traditional medical device clinical trial with a test set of data and ground truth established by experts.

Sample size used for the test set and the data provenance: Information regarding the specific sample sizes for tests such as tensile strength, elongation, freedom from holes, and powder content is not explicitly stated in this summary. The tests were performed in accordance with ASTM standards, which would specify appropriate sample sizes. The data provenance is internal testing conducted by the manufacturer, Central Medicare Sdn. Bhd., in Malaysia.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is not applicable as the evaluation is based on objective measurements against engineering and material standards (ASTM, ISO) rather than expert interpretation of medical images or patient outcomes. The "ground truth" is defined by these established industry standards.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: This is not applicable as the evaluation relies on direct physical and chemical measurements rather than subjective assessment requiring adjudication.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This is not applicable. The device is an examination glove, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is not applicable. The device is an examination glove, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" is based on established industry standards and test methods, specifically:
- ASTM D6319-10: Standard Specification for Nitrile Examination Gloves for Medical Application
- ASTM D5151-06 (Reapproved 2011): Standard Test Method for Detection of Holes in Medical Gloves
- ASTM D6124-06 (Reaffirmation 2011): Standard Test Method for Residual Powder on Medical Gloves
- ISO 2859-1:1999: Sampling Procedures for Inspection by Attributes - Part I: Sampling Plans Indexed by Acceptable Quality Level (AQL) for Lot-by-Lot Inspection
- ISO 10993-10:2010: Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
- ASTM D412-16: Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers - Tension
- ASTM D7160-16: Standard Practice for Determination of Expiration Dating for Medical Gloves
- ASTM D573-04: Standard Test Method for Rubber—Deterioration in an Air Oven
- 16 CFR 1500.41: Method of testing primary irritant substances
- FDA Medical Glove Guidance Manual (Document issued on January 22, 2008)
The sample size for the training set: This is not applicable. This is a physical medical device, not a machine learning algorithm requiring a training set.
How the ground truth for the training set was established: This is not applicable for the same reason as above.

Summary

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

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, 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.

November 28, 2017

Central Medicare Sdn. Bhd. Arivalagan Subramaniam QA/RA Manager PT 2609 - 2620, BT 8, Jalan Changkat Jong Teluk Intan, 36000 My

Re: K172642

Trade/Device Name: Orange Non Sterile Powder Free Nitrile Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA Dated: August 25, 2017 Received: September 1, 2017

Dear Arivalagan Subramaniam:

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.

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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

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

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known)

K172642

Device Name

Orange Non Sterile Powder Free Nitrile Examination Gloves

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."

{3}------------------------------------------------

Section 2 - 510(k) Summary

Date of Summary Prepared: 25th August 2017

1.0 Submitter:

Name:	Arivalagan SubramaniamQA/RA Manager
Address:	Central Medicare Sdn. Bhd.PT 2609-2620, Batu 8,Jalan Changkat Jong, 36000 Teluk Intan,Perak, Malaysia
Contact:	Tel: +605-629 0000 Fax: +605-629 0001
510(k) Submission Prepared by:	Muhammad Abdul RahmanRegulatory Affairs OfficerCentral Medicare Sdn. Bhd.

2.0 Name of the device:

Orange Non Sterile Powder Free Nitrile Examination Gloves

Common Names:	Examination Gloves
Device Class:	Class I
Classification Names:	Patient Examination Gloves (21 CFR 880.6250 product codeLZA)
Review Panel:	General Hospital

3.0 Identification of the Legally Marketed Devicesthat equivalency isclaimed:

	Proposed Device	Predicate Device	Remark
Sponsor	Central Medicare Sdn. Bhd.(as both the sponsor and manufacturer)	Central Medicare Sdn. Bhd.(as both the sponsor and manufacturer)	Same
Trade Name	Orange Non Sterile Powder Free NitrileExamination Gloves	Powder Free Nitrile Examination Gloves,Non Sterile, (Blue Colored, Black Colored,and White Colored)	Similar
510k Number		K143247
Product Code	LZA	LZA	Same
Regulation Number	21 CFR 880.6250	21 CFR 880.6250	Same
Class			Same

4.0 Description of the Device:

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

PT 2609 – 2620, Jalan Changkat Jong, Mukim Changkat Jong, 36000 Teluk Intan, Perak. Tel: +605 629 0000 Fax: +605 629 0001

Section 2 - 510(k) Summary

5.0 Intended Use of the Device:

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

6.0 Summary of the Technological Characteristics of the Device:

The proposed and predicate devices all share the same technological characteristics and design by meeting ASTM D6319-10 and following the FDA's Medical Glove Guidance Manual.

The purpose of this submission is to demonstrate that the proposed device is substantially equivalent, to a legally marketed predicate device, K143247, Powder Free Nitrile Examination Gloves, Non Sterile, (Blue Colored, Black Colored, and White Colored). The proposed device will be known as Orange Non Sterile Powder Free Nitrile Examination Glove.

Biocompatibility studies were performed on the proposed device. Under the conditions of the study, the proposed device is not a sensitizer, or an irritant.

The proposed and predicate devices are made of nitrile synthetic latex. The proposed device have similar technological characteristics compared to the predicate devices, as both devices meet ASTM D6319-10 and follow FDA's Medical Glove Guidance Manual.

The technological characteristics and design for the proposed device have been assessed and confirmed that the standard specifications and performance are appropriate for the requirements of a powder free nitrile examination glove.

The following tables are summaries of the technological characteristics of the proposed and predicate devices.

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

PT 2609 – 2620, Jalan Changkat Jong, Mukim Changkat Jong, 36000 Teluk Intan, Perak. Tel: +605 629 0000 Fax: +605 629 0001

Section 2 - 510(k) Summary

General Comparison Table:

	Proposed Device	Predicate Device	Remark
Sponsor	Central Medicare Sdn. Bhd.(as both the sponsor and manufacturer)	Central Medicare Sdn. Bhd.(as both the sponsor and manufacturer)	Same
Trade Name	Orange Non Sterile Powder Free NitrileExamination Gloves	Powder Free Nitrile Examination Gloves,Non Sterile, (Blue Colored, BlackColored,and White Colored)	Similar
510k Number		K143247
Product Code	LZA	LZA	Same
Regulation Number	21 CFR 880.6250	21 CFR 880.6250	Same
Class	I	I	Same
Indications for Use	Orange Non Sterile Powder Free NitrileExamination Glovesisa disposable deviceintended for medical purposes that is wornon the examiner's hands to preventcontamination between patient andexaminer.	Powder Free Nitrile Examination Gloves,Non Sterile, (Blue Colored, Black Colored,and White Colored) isa disposable deviceintended for medical purposes that is wornon the examiner's hands to preventcontamination between patient andexaminer.	Same
Powder or PowderFree	Powder Free	Powder Free	Same
Design Feature	Ambidextrous	Ambidextrous	Same
Color	Orange	Blue, Blackand White	Similar
LabelingInformation	Single-use indication, powder free, devicename, glove size, quantity, NitrileExamination Gloves, Non Sterile	Single-use indication, powder free, devicename, glove size, quantity, NitrileExamination Gloves. Non Sterile	Same

DimensionsTable:

Proposed Device
	Size						Tolerance
		XS	S	M	L	XL
Orange Non SterilePowder Free NitrileExamination Gloves	Length (mm)	minimum 230
	Width (mm)	70	80	95	110	120	±0.10
	Thickness (mm)
	Palm						-
	Finger						-
	Predicate Device
		Size					Tolerance
Powder Free NitrileExamination Gloves, NonSterile, (Blue Colored,Black Colored, and WhiteColored)		XS	S	M	L	XL		Same
	Length (mm)	minimum 230
	Width (mm)	70	80	95	110	120	±0.10
	Thickness (mm)
	Palm						-
	Finger						-
	Standard Specification
		Size						Tolerance
ASTM D6319 - 10(2015)Standard SpecificationforNitrile ExaminationGloves for MedicalApplication		XS	S	M	L	XL
	Length (mm)	minimum 230
	Width (mm)	70	80	95	110	120	±0.10
	Thickness (mm)
	Palm						-
	Finger						-

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

PT 2609 – 2620, Jalan Changkat Jong, Mukim Changkat Jong, 36000 Teluk Intan, Perak. Tel: +605 629 0000 Fax: +605 629 0001

Section 2 - 510(k) Summary

Performance Comparison Table:

Item			Proposed Device	Predicate Device
		Color	Orange Non Sterile PowderFree Nitrile ExaminationGloves	Powder Free NitrileExamination Gloves, NonSterile, (Blue Colored, BlackColored, and White Colored)	Remark
		Color	Orange	Blue, Black and White	Similar
PhysicalProperties	BeforeAging	Tensile Strength	15 Mpa min	15 Mpa min	Same
		Ultimate Elongation	500% min	500% min	Same
	AfterAging	Tensile Strength	14 Mpa min	14 Mpa min	Same
		Ultimate Elongation	400% min	400% min	Same
Freedom from Holes			h accordance with ASTMD5151-06, following ASTMD6319 AQL 2.5/InspectionLevel G-I	h accordance with ASTMD5151-06, following ASTMD6319 AQL 2.5/InspectionLevel G-I	Similar
Powder Content			Max. 0.50 mg per glove	Max. 0.40 mg per glove	Similar

Biocompatibility and Labeling:

Item	Proposed Device	Predicate Device	Remark
	Orange Non Sterile Powder FreeNitrile Examination Gloves	Powder Free Nitrile ExaminationGloves, Non Sterile, (Blue Colored,Black Colored, and White Colored)
Material	Nitrile	Nitrile	Same
Biocompatibility	Irritation	Under the conditions of the study,not an irritant	Under the conditions of the study,not an irritant	Same
	Sensitization	Under the conditions of the study,not a sensitizer	Under the conditions of the study,not a sensitizer	Same
Labeling	Meet FDA's Recommendations	Meet FDA's Recommendations	Same

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

The proposed device and it's predicate device share intended use, are made of the same material, are within the same minimum specifications of thickness and length by meeting ASTM D6319-10, similar labeling, physical properties, freedom from powder, biocompatibility and water tightness.

The above test results demonstrated that the proposed device complies with the following specification and guidance:

ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application

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

PT 2609 - 2620, Jalan Changkat Jong, Mukim Changkat Jong, 36000 Teluk Intan, Perak. Tel: +605 629 0000 Fax: +605 629 0001

Section 2 - 510(k) Summary

Guidance for Industry and FDA Staff Medical Glove Guidance Manual (Document issued on January 22, 2008)

The following standards were followed to carry out the testing: ASTM D5151-06 (Reapproved 2011), Standard Test Method for Detection of Holes in Medical Gloves.

ASTM D6124-06 (Reaffirmation 2011), Standard Test Method for Residual Powder on Medical Gloves.

ISO 2859-1:1999, "Sampling Procedures for Inspection by Attributes - Part I: Sampling Plans Indexed by Acceptable Quality Level (AQL) for Lot-by-Lot Inspection.

ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.

ASTM D412-16 Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers - Tension

ASTM D7160-16 Standard Practice for Determination of Expiration Dating for Medical Gloves

ASTM D573 - 04 Standard Test Method for Rubber—Deterioration in an Air Oven ISO 10993-10:2010 - Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization

16 CFR 1500.41 - Method of testing primary irritant substances

8.0 Substantial Equivalence Based on Assessment of Clinical Performance Data

Clinical data is not necessary for Class I Patient Examination Glove 510(k) Submissions.

9.0 Conclusion

Based on intended uses, technological characteristics and non-clinical performance data, the proposed device is substantially equivalent to the predicate device Powder Free Nitrile Examination Gloves, Non Sterile, (Blue Colored, and White Colored) (K143247).

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.