A 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.

Device Description

Powder Free Blue Nitrile Examination Glove meets all the current specifications listed under the ASTM Specification D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application. The principle operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for over-the counter single use.

AI/ML Overview

This response is tailored to a medical device's performance evaluation, specifically a Nitrile Examination Glove, based on the provided FDA 510(k) summary. The document describes the testing performed to demonstrate substantial equivalence to a predicate device, rather than a novel AI/software medical device. Therefore, aspects related to AI (e.g., human-in-the-loop, training/test sets, expert adjudication, MRMC studies) are not applicable and are addressed as such.

Here's the breakdown of the acceptance criteria and study proving device performance:

Device Name: Powder Free Blue Nitrile Examination Glove (K210375)
Predicate Device: Powder Free Blue Nitrile Examination Glove (K153562)

1. Table of Acceptance Criteria and Reported Device Performance

The device performance is evaluated against established ASTM and ISO standards for examination gloves.

Test Method (Reference Standard)	Purpose	Acceptance Criteria	Reported Device Performance (Results)
ASTM D6124	To check the amount of powder residue from glove surface	Less than 2mg/glove	Pass (Average powder residue for each size: S: 0.61 mg/glove, M: 0.59 mg/glove, L: 0.57 mg/glove)
ASTM D5151	To detect the presence of hole in glove	Meet AQL 2.5 from sampling of the lot	Pass
ASTM D6319	To measure the following physical parameters of the glove: a) Length b) Palm Thickness c) Tensile Strength before age d) Tensile Strength after age e) Elongation before age f) Elongation after age	a) Length at minimum 230mm b) Palm Thickness at minimum 0.05mm c) Tensile strength before age at minimum 14MPa d) Tensile Strength after age at minimum 14MPa e) Elongation before age at minimum 500% f) Elongation after age at minimum 400%	Pass (Reported averages meet or exceed criteria for all sizes)
ISO 10993-10	To determine the irritation potential of glove when exposed to skin surface (Primary Skin Irritation Test) and to evaluate potential for Type IV allergy (Skin Sensitization Test)	a) Not an Irritant b) Not a Sensitizer	Pass (Not an irritant, Not a sensitizer)
ISO 10993-11	To evaluate the human hazard potential from glove (Acute Systemic Toxicity)	Not induce systemic toxicity	Pass (Did not induce systemic toxicity)

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a distinct "test set" in the context of an AI/ML device validating against a separate dataset. Instead, it refers to non-clinical tests performed on the "proposed device" (the Nitrile Examination Glove).

Sample Size: The document does not explicitly state the sample sizes for each test (e.g., number of gloves tested for holes, tensile strength, etc.). However, it refers to standard practices like "sampling of the lot" for ASTM D5151 (Holes), and implies multiple samples for calculating averages for physical properties (D6319) and powder residue (D6124) across different glove sizes (S, M, L). For biocompatibility tests (ISO 10993), specific animal or in-vitro sample sizes are common for such assessments but are not detailed here. ASTM and ISO standards typically outline appropriate sampling plans.
Data Provenance: The data is generated from performance testing of the "Powder Free Blue Nitrile Examination Glove" from Duramitt Sdn Bhd, located in Kulim, Kedah, Malaysia. These are prospective test results generated for the purpose of this 510(k) submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This section is not applicable as the described device is a physical medical glove, not an AI/software device that requires human expert annotation for establishing ground truth on a dataset. The "ground truth" for glove performance is established by standardized physical, chemical, and biological testing methods (e.g., measuring dimensions, tensile strength, conducting irritation tests in a lab setting) as per ASTM and ISO standards.

4. Adjudication Method for the Test Set

This section is not applicable. Since the device is a physical product and the "ground truth" is determined by objective, standardized laboratory tests, there is no need for expert adjudication of results as would be the case for subjective interpretations in an expert-based AI/ML ground truth dataset. Test results are quantified and compared to predefined criteria.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This section is not applicable. An MRMC study is relevant for evaluating the impact of an AI system on human reader performance for tasks involving interpretation (e.g., radiology image reading). This submission pertains to a physical medical glove, which does not involve human "readers" or AI assistance in its primary function or evaluation.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop)

This section is not applicable. This concept applies to AI algorithms. The performance of the medical glove is evaluated as a standalone product based on its physical properties and biocompatibility as per the listed standards. There is no "algorithm" to evaluate.

7. Type of Ground Truth Used

The "ground truth" for the device's performance is established by compliance with recognized international consensus standards (ASTM, ISO). These standards define objective, measurable criteria for physical properties (e.g., length, thickness, tensile strength, elongation), barrier integrity (freedom from holes), and biological safety (biocompatibility).

Physical Properties: Measured directly (e.g., length, thickness) or through standardized mechanical testing (tensile strength, elongation).
Barrier Integrity: Determined by a standardized water leak test (ASTM D5151).
Biocompatibility: Assessed through standardized biological evaluation methods (ISO 10993-10 for irritation/sensitization, ISO 10993-11 for systemic toxicity), typically involving in-vitro or animal models as per the standard's guidelines.

8. Sample Size for the Training Set

This section is not applicable. There is no "training set" as this is not an AI/ML device.

9. How the Ground Truth for the Training Set Was Established

This section is not applicable. Since there is no training set (as this is not an AI/ML device), no ground truth establishment for such a set was performed.

Summary

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

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

June 21, 2021

Duramitt sdn Bhd Terence Lim RA Specialist No. 3, Jalen Baling Padong Meha Industrial Estate Padang Serai Kulim, Kedah 09400 Malaysia

Re: K210375

Trade/Device Name: Powder Free Blue Nitrile Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: May 16, 2021 Received: May 24, 2021

Dear Terence Lim:

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,

Ryan Ortega, PhD Acting 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}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K210375

Device Name

门 Powder Free Blue Nitrile Examination Glove

Indications for Use (Describe)

A 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.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

FORM FDA 3881 (9/13)

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

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."

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

No. 3, Jalan Baling, Padong Meha Industrial Estate, Padang Serai, Kulim 09400, Kedah, Malaysia

Attachment 3

510 (K) SUMMARY SHEETS

1.0

510 (K) SUMMARY

2.0 Submitter	Duramitt Sdn Bhd
	No. 3, Jalan Baling, Padong Meha Industrial EstatePadang Serai, Kulim 09400, Kedah, Malaysia
Tel:	+60-3-87668191
Fax:	+60-3-87668191
Name of Contact Person:	Terence Lim
Email Address:	limsinkooi@gmail.com
Date of Summary Prepared:	January 17, 2021

3.0 Name of Device:

510(k) number	K210375
Trade Name:	Powder Free Blue Nitrile Examination Glove
Classification Name:	Polymer Patient Examination Glove
Device Classification:	I
Regulation Number:	21 CFR 880.6250
Panel:	General Hospital
Product Code:	LZA

4.0 Identification of The Legally Marketed Device

Predicate Device Name: Powder Free Blue Nitrile Examination Glove

Predicate 510(K) Number: K153562

Manufacturer's Name: VIETGLOVE CORPORATION

5.0 Description of Device

6.0 The Intended Use of Glove

A patient examination gloves 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

7.0 Summary of the Technological Characteristic of the Device compared to the Predicate Device for Substantial Equivalent Discussion.

There is no difference in technology characteristic compared to the predicate device. Gloves are made from nitrile latex compound. Non-Sterile, Powder Free Blue Nitrile Examination Gloves has the below technological characteristic compared to ASTM or Equivalent standards.

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

No. 3, Jalan Baling, Padong Meha Industrial Estate, Padang Serai, Kulim 09400, Kedah, Malaysia

Comparison between Proposed Device & Predicate Device

Characteristics andParameters	Proposed Device -Powder Free NitrileExamination Gloves(K210375)	Predicate Device -Powder Free BlueNitrile ExaminationGloves (K153562 )	Discussion
Product Code	LZA	LZA	Same product Code
Intended Use	A patient examinationglove is a disposabledevice intended formedical purposes thatis worn on the hand orfinger to preventcontamination betweenpatient and examiner.	A patient examinationglove is a disposabledevice intended formedical purposes thatis worn on the hand orfinger to preventcontaminationbetween patient andexaminer.	Same Intended Use.
Classification	Class 1	Class 1:	Same Class.
Raw Rubber Material	Nitrile (Acrylonitrile-butadiene)	Nitrile (Acrylonitrile-butadiene)	Same synthetic rubbermaterial.
Surface Appearance	1.Blue2. Ambidextrous3.Finger Textured	1.Blue2. Ambidextrous3.Finger Textured	Same color, ambidextrousdesign and same texturearea.
Freedom of HolesMeet AQL 2.5 at G1	Meet AQL 1.5 withG1	Meet AQL 1.5 withG1.	Similar
Overall LengthMinimum 230mm	Average :S : 242 mmM : 242 mmL : 243 mm	More than 230mm	Similar
WidthS : 75mm - 95mmM: 85mm – 105mmL: 100mm – 120mm	Average :S : 84 mmM : 96 mmL : 107 mm	Meetingspecification	Similar
Palm Thickness(Minimum 0.05mm)	Average :S : 0.06 mmM : 0.06 mmL : 0.06 mm	More than 0.05mm	Similar
Finger Thickness(Minimum 0.05mm)	Average :S : 0.08 mmM : 0.08 mmL : 0.08 mm	More than 0.05mm	Similar
Tensile Strength(before age)Minimum 14 MPa	Average :S : 19.37 MPaM : 19.04 MPaL : 19.81 MPa	More than 14 MPa	Similar
Tensile Strength(After Age)Minimum 14 MPa	Average :S : 84 mmM: 94mmL 103mm	More than 14 MPa	Similar
Characteristics andParameters	Proposed Device -Powder Free NitrileExamination Gloves(K210375)	Predicate Device -Powder Free BlueNitrile ExaminationGloves (K153562 )	Discussion
Ultimate Elongationbefore age(Minimum 500%)	Average :S : 560%M : 560%L : 560%	Minimum 500%	Similar
Ultimate Elongationafter age(Minimum 400%)	Average :S : 500%M: 510%L : 510%	Minimum 400%	Similar
Residual powder test(Less than2mg/glove)	Average powderresidue for each size:S : 0.61 mg/gloveM : 0.59 mg/gloveL : 0.57 mg/glove	Contained less than2mg/glove	Similar
Primary Skin Irritation	Under the conditionsof study, not anirritant	Under the conditionsof study, not anirritant	Similar
Dermal Sensitization	Under the conditionsof study, not asensitizer.	Under the conditionsof study, not asensitizer.	Similar
Acute SystemicToxicity	Not induce systemictoxicity	Not done	Meeting the requirementsper ISO 10993-11

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

No. 3, Jalan Baling, Padong Meha Industrial Estate, Padang Serai, Kulim 09400, Kedah, Malaysia

Non-Clinical Test Conclusion

Non-clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed

Device complies with the following standards:

ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
. ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
ASTM D6124-06,Standard Test Method for Residual Powder on Medical Gloves .
ASTM D5151-06, Standard Test Method for Detection of Holes in Medical Gloves. ●
. ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application
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.

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

No. 3, Jalan Baling, Padong Meha Industrial Estate, Padang Serai, Kulim 09400, Kedah, Malaysia

Test Method	Purpose	Acceptance Criteria	Results
ASTM D6124	To check the amount of powderresidue from glove surface	Less than 2mg/glove	Pass
ASTM D5151	To detect the presence of hole inglove	Meet AQL 2.5 from sampling ofthe lot	Pass
ASTM D6319	To measure the following physicalparameters of the glovea) Lengthb) Palm Thicknessc) Tensile Strength before aged) Tensile Strength after agee) Elongation before agef) Elongation after age	a) Length at minimum 230mmb) Palm Thickness at minimum0.05mmc) Tensile strength before ageat minimum 14MPad) Tensile Strength after age atminimum 14MPae) Elongation before age atminimum 500%f) Elongation after age atminimum 400%	Pass
ISO 10993	To determine the irritation potentialof glove when expose to skinsurface and also to evaluatewhether residual chemical additivesat the level that may induce Type IVallergya) Primary Skin Irritation Testb) Skin Sensitization Test	a) Not an Irritantb) Not a Sensitizer	Pass
ISO 10993-11	To evaluate the human hazardpotential from glove	a) Not induce systemic toxicity	Pass

Clinical Test Conclusion

No clinical test is included in this submission.

Conclusion

The conclusion drawn from the nonclinical tests demonstrates the subject device in 510(K) submission K210375, Powder Free Nitrile Examination Glove is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K153562.

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.