A patient examination glove 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

Powder Free Nitrile Patient Examination Glove, Blue Colored, and White (Non Colored), Non-Sterile meets all of the requirements of ASTM D 6319-10. The gloves are ambidextrous single-use disposable devices that come in five sizes (XS, S, M, L, XL) in blue or white color.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the device, based on the provided text:

Acceptance Criteria and Device Performance

Characteristic	Acceptance Criteria (Standards)	Reported Device Performance
Dimensions	ASTM D 6319-10	Meets
Physical Properties	ASTM D 6319-10	Meets
Freedom from Pinholes	ASTM D 5151-06, ASTM D 6319-10	Meets
Powder Free Residue	ASTM D 6124-06, ASTM D 6319-10	Meets
Biocompatibility:
- Dermal Sensitization	ISO 10993-10:2010	Not a contact skin sensitizer
- Primary Skin Irritation	16 CFR Part 1500 (Primary Skin Irritation Test)	Not a primary skin irritant

Study Information

The provided document describes a 510(k) Premarket Notification for a medical device (Powder Free Nitrile Patient Examination Glove). For this type of submission, the primary goal is to demonstrate substantial equivalence to a predicate device, rather than conducting extensive clinical studies to prove effectiveness from scratch. Therefore, the "study" mainly refers to the non-clinical performance data demonstrating compliance with established standards.

1. Sample size used for the test set and the data provenance:

Test Set Sample Size: The document does not specify exact sample sizes for each test conducted (e.g., how many gloves were tested for pinholes, dimensions, etc.). It generally states that the device "Meets" the respective ASTM and ISO standards, implying that the number of samples tested was sufficient to establish conformity according to those standards.
Data Provenance: The testing was performed by the manufacturer, WSM WEAR SAFE (MALAYSIA) SDN BHD, located in Malaysia. The data is retrospective, as it refers to performance tests conducted on the device to demonstrate compliance with standards for the 510(k) submission.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This type of information is not applicable to this submission. The "ground truth" for glove performance is established by widely accepted international and national standards (ASTM, ISO, CFR). The experts involved would be the engineers and quality assurance personnel at the manufacturing facility who conducted the tests and verified compliance with these objective standards. Their qualifications are inherent in their ability to perform and interpret these standardized tests.

3. Adjudication method for the test set:

Not applicable in the context of expert adjudication for clinical outcomes. The "adjudication" here is the comparison of the device's measured performance against the quantitative and qualitative requirements outlined in the specified standards. Compliance is determined by whether the test results fall within the acceptable ranges or pass/fail criteria of those standards.

4. 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:

No, this was not done. The device in question is a patient examination glove, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to human reader improvement with or without AI assistance is irrelevant and not performed.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No, this was not done. Again, this is a physical medical device (glove), not a software algorithm. The concept of "standalone" algorithm performance does not apply.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The ground truth for this device's performance is based on established industry standards and regulatory requirements. For example:
- Dimensions, Physical Properties, Freedom from Pinholes, Powder Free Residue: The ground truth is defined by the specifications and test methods outlined in ASTM D 6319-10, ASTM D 5151-06, and ASTM D 6124-06.
- Biocompatibility: The ground truth for biocompatibility is defined by the test methods and acceptance criteria specified in ISO 10993-10:2010 (for dermal sensitization) and 16 CFR Part 1500 (for primary skin irritation).

7. The sample size for the training set:

Not applicable. This device is a physical medical product, not a machine learning model, so there is no "training set." The manufacturing process would have internal quality control and verification procedures, but these are distinct from AI model training.

8. How the ground truth for the training set was established:

Not applicable. As there is no training set, the question of how its ground truth was established is not relevant.

Summary

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WSM WEAR SAFE (MALAYSIA) SDN BHD

(Company No. 204396-X)

FDA 510(k), Premarket Notification: 510(k) Summary of Safety and Effectiveness Information

1.0 Submitter:

K423469

Wear Safe (Malaysia) Sdn Bhd - Facility II LOT 63616, PT 54924, NO 3, Jalan Korporat 7C/KU9, Taman Perindustrian Meru, Mukim Kapar, 42200 Klang, Selangor, Malaysia

Telephone No.:	+603-3393 6088
Fax No.:	+603-3393 3688

2.0 Contact Person:

Contact:	Mr Alex Yoong
Telephone No.:	+603-3393 6088
Fax No .:	+603-3393 3688

3.0 Preparation Date: 15 February 2013

4.0 -Name of Device:

Trade Name: Powder Free Nitrile Patient Examination Glove, Blue Colored, and White (Non-Colored). Non-Sterile, Polymer Coated Powder Free Nitrile Patient Examination Glove, Blue Colored, and White (Non-Colored). Non-Sterile, Without Polymer (Chlorinated) Common Name: Powder-Free Nitrile Patient Examination Glove Classification Name: Patient Examination Glove (21 CFR Part 880.6250, Product Code LZA)

5.0 Identification of the Legally Marketed Device:

Powder Free Nitrile Patient Examination Glove, Blue Colored, and White (Non Colored), Non-Sterile; Class I Patient Examination Gloves, Nitrile-80LZA, meets all of the requirements of ASTM D 6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application.

Predicate Device 1: K093500, Powder Free Nitrile Examination Glove, White (Non-Colored) and Blue (Colored), Non-Sterile (Chemotherapy Drug Protection Labeling Claim).

Predicate Device 2: K111772, Powder Free Nitrile Patient Examination Glove, Blue Colored and White (Non-Colored), Non-Sterile.

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WSM WEAR SAFE (MALAYSIA) SDN BHD

(Company No. 204396-X)

There are no different technological characteristics compared to the Predicate Devices. They are all Powder Free Non-Sterile Nitrile Examination Gloves, one predicate polymer coating (K111772), and the other on-line chlorination (K093500).

6.0 Description of Device:

Intended Use of the Device: 7.0

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

8.0 Summary of the Technological Characteristics of the Device:

Powder Free Nitrile Patient Examination Glove, Blue Colored, and White (Non Colored). Non-Sterile possesses the following technological characteristic (as compared to ASTM or equivalent standards):

Characteristic	Standards	Device Performance
Dimensions	ASTM D 6319-10	Meets
Physical Properties	ASTM D 6319-10	Meets
Freedom from pin-holes	ASTM D 5151-06	Meets
	ASTM D 6319-10	Meets
Powder Free Residue	ASTM D 6124-06	Meets
	ASTM D 6319-10	Meets
Biocompatibility	Dermal Sensitization(as per ISO 10993-10:2010)	Not a contact skin sensitizer
	Primary SkinIrritation Test(as per 16 CFR Part1500)	Not a primary skin irritant

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

The performance test data that support a determination of substantial equivalence are described above.

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WSM WEAR SAFE (MALAYSIA) SDN BHD

(Company No. 204396-X)

10.0 Substantial Equivalent Based on Assessment of Clinical Performance Data

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

11.0 Conclusion

Powder Free Nitrile Patient Examination Glove, Blue Colored, and White (Non Colored), Non-Sterile performs according to the glove performance standards referenced in Section 8.0 above. This device is substantially equivalent to current marketed devices per Section 12.0.

12.0 Substantial Equivalence Comparison and Analysis

The gloves are identical to Predicate Device cleared under 510(k) K093500 with Proposed Device not tested for use with chemotherapy drugs. The difference with Chemotherapy Protection Labeling Claim in Predicate Device, does not affect the safety and effectiveness of the Proposed Device that is not tested for Chemotherapy Drugs used.

The gloves are also identical to Predicate Device cleared under 510 (k) K111772, both devices are not tested for use with chemotherapy drugs. Predicate Device is with Polymer Coated Labeling Claim, while Proposed Device is with Polymer Coated optional labeling claim.

There is difference in Blue colorant used in Proposed Device, compared with Predicate Devices. The difference Does Not affect the safety and effectiveness of the Proposed Device, as the Proposed Device Pass biocompatibility test, similar with Predicate Devices.

There is no difference between the Proposed Device and the Predicates with respect to indications for use and technological characteristics.

As such, this device is substantially equivalent to currently marketed devices. The Substantial Equivalence Comparison is summarized per Table below:-

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WSM WEAR SAFE (MALAYSIA) SDN BHD

Substantial Equivalence Comparison Table

Characteristics	Predicate Device 1	Proposed Device	Predicate Device 2	Proposed Device
	K093500, Powder FreeNitrile Examination Glove,White (Non-Colored) andBlue (Colored), Non-Sterile(Chemotherapy DrugProtection Labeling Claim)of Wear Safe (Malaysia)Sdn Bhd	Powder Free NitrilePatient ExaminationGlove, Blue Colored,and White (NonColored), Non-Sterile	K111772, Powder FreeNitrile PatientExamination Glove, BlueColored and White (Non-Colored), Non-Sterile ofKossan Latex Industries(M) Sdn Bhd.	Powder Free Nitrile PatientExamination Glove, BlueColored, and White (NonColored), Non-Sterile
Product Code	80 LZC	80 LZA	80 LZA	Identical
Intended Use	Intended for medical purposesthat is worn on the examiner'shand to prevent contaminationbetween patient and examiner.	Identical	Intended for medicalpurposes that is worn on theexaminer's hand to preventcontamination betweenpatient and examiner.	Identical
Design	Powder Free, Non Sterile,Ambidextrous, Beaded Cuff	Identical	Powder Free, Non Sterile,Ambidextrous, Beaded Cuff	Identical
Indications for Use	A powder free nitrileexamination glove is adisposable device made ofsynthetic material intended tobe worn on the hand formedical purposes to providebarrier against potentiallyinfectious materials and othercontaminants.In addition, this product istested for use withchemotherapy drugs	Identical	A patient examination gloveis a disposable deviceintended for medicalpurposes that is worn on theexaminer's hand to preventcontamination betweenpatient and examiner.	Identical
Characteristics	Predicate Device 1K093500, Powder Free Nitrile Examination Glove, White (Non-Colored) and Blue (Colored), Non-Sterile (Chemotherapy Drug Protection Labeling Claim) of Wear Safe (Malaysia) Sdn Bhd	Predicate Device 2K111772, Powder Free Nitrile Patient Examination Glove, Blue Colored and White (Non-Colored), Non-Sterile of Kossan Latex Industries (M) Sdn Bhd.	Proposed DevicePowder Free Nitrile Patient Examination Glove, Blue Colored, and White (Non Colored), Non-Sterile
Construction	Ambidextrous, Chlorinated, Powder Free Nitrile.	Ambidextrous, Polymer Coated, Powder Free Nitrile.	Ambidextrous, Polymer Coated or Chlorinated, Powder Free.
Color Description	Blue and White	Blue and White	Identical
Materials	Nitrile	Nitrile	Identical
PerformanceI. Sterility	Non-Sterile	Non-Sterile	Identical
II. Freedom from holes	Meets ASTM D6319	Meets ASTM D6319	Identical
III. Dimension	Meets ASTM D6319	Meets ASTM D6319	Identical
IV. Physical Properties	Meets ASTM D6319	Meets ASTM D6319	Identical
V. Powder Free Residue	Meets ASTM D6319	Meets ASTM D6319	Identical
Single Use	Yes	Yes	Identical
Biocompatibility Test	Passesi. Primary Skin Irritation Testii. Dermal Sensitization Test	Passesi. Primary Skin Irritation Testii. Dermal Sensitization Test	Identical
Characteristics	Predicate Device 1K093500, Powder Free NitrileExamination Glove, White (Non-Colored) andBlue (Colored), Non-Sterile (ChemotherapyDrug Protection Labeling Claim)of Wear Safe (Malaysia) Sdn Bhd	Proposed DevicePowder Free NitrilePatient ExaminationGlove, Blue Colored, andWhite (Non Colored), Non-Sterile	Predicate Device 2K111772, Powder Free NitrilePatient Examination Glove, BlueColored and White (Non-Colored), Non-Sterile ofKossan Latex Industries(M) Sdn Bhd.	Proposed DevicePowder Free Nitrile PatientExamination Glove, BlueColored, and White (NonColored), Non-Sterile
Packaging	Packed in Dispenser Boxes	Identical	Packed in Dispenser Boxes	Identical
Labeling Claim	Tested For Use withChemotherapy DrugsLabeling Claim	Not Tested For Use withChemotherapy Drugs	i. NO ChemotherapyDrugs Labeling Claimii. Polymer CoatedLabeling Claim	Optional Polymer CoatedLabeling Claim

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WSM WEAR SAFE (MALAYSIA) SDN BHD
Comment

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WSM WEAR SAFE (MALAYSIA) SDN BHD
(00000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000

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Image /page/6/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of stylized lines.

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

February 19, 2013

Mr. Alex Yoong Quality Assurance Manager . Wear Safe (Malaysia) Sdn Bhd - Facility II Lot 63616. PT 54924, NO 3, Jalan Korporat 7C/KU9 Taman Perindustrian Meru Mukim Kapar, Klang Selangor, Malaysia 42200

Re: K123469

Trade/Device Name: Powder Free Nitrile Patient Examination Gloves, Blue Colored and White (Non-Colored), Non-Sterile, Polymer Coated Powder Free Nitrile Patient Examination Gloves, Blue Colored and White (Non-Colored), Non-Sterile, Without Polymer (Chlorinated)

Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: January 2, 2013 Received: January 10, 2013

Dear Mr. Yoong:

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

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Page 2 - Mr. Yoong

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 devicerelated 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 n you aco.il/www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours,

hori
Theti
Fawshukio.

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Respiratory, Infection Control and

Dental Devices Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

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Indications for Use

K123469

510(k) Number (if known):

Device Name:

Powder Free Nitrile Patient Examination Gloves, Blue Colored and White (Non-Colored), Non-Sterile, Polymer Coated Powder Free Nitrile Patient Examination Gloves. Blue Colored and White (Non-Colored), Non-Sterile, Without Polymer (Chlorinated)

Indications for Use:

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

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C) .

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office Of Device Evaluation (ODE)

Elizabeth-F.Claverie
2013.02.15 22:09:47 -05'00'

(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K123469

Page 1 of _

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.