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

The Powder Free Blue Latex Examination Glove, Non-sterile (Protein Content Labeling) meets all the requirements of ASTM standard D 3578 - 01 Type I and FDA 21 CFR 800.20.

AI/ML Overview

The device in question is the "Powder Free Blue Latex Examination Glove, Non-sterile (Protein Content Labeling)", which is a patient examination glove.

Acceptance Criteria and Device Performance:

The acceptance criteria for the glove are based on established ASTM standards and FDA regulations. The device's performance is reported to meet all these criteria.

Characteristics	Standards	Acceptance Criteria	Reported Device Performance
Dimensions	ASTM D 3578 - 01	Meets ASTM D 3578 - 01	Meets
Physical Properties	ASTM D 3578 - 01	Meets ASTM D 3578 - 01	Meets
Freedom from pinholes	ASTM D 3578 - 01FDA 21 CFR 800.20	Meets ASTM D 3578 - 01 and FDA 21 CFR 800.20	Meets
Powder-Free	ASTM D 6124 - 00	< 2 mg/glove	< 2 mg/glove
Protein Level	ASTM D 5712 - 99	< 50 μg/g	< 50 μg/g
Biocompatibility	Primary Skin Irritation in RabbitsDermal Sensitization	Passes (Not a primary skin irritant)Passes (Not a contact sensitizer)	Passes

Study Information:

For this type of medical device (patient examination glove), the submission explicitly states that clinical data is not needed. The assessment of device performance relies on non-clinical performance data, which includes the physical and chemical tests outlined in the table above.

Given that no clinical study was conducted or required:

Sample size used for the test set and the data provenance: Not applicable, as no clinical test set was used. The performance is based on laboratory testing against standards for characteristics like dimensions, physical properties, pinholes, powder content, and protein level. These tests are typically performed on samples from manufacturing batches. The data provenance would be from manufacturing and testing facilities in Malaysia (country of origin for the submitter).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for these physical and chemical tests is established by adhering to widely accepted ASTM standards and laboratory protocols, not by expert consensus in a clinical setting.
Adjudication method for the test set: Not applicable, as there was no clinical test set requiring adjudication. Laboratory test results are compared directly against the specified standards.
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: Not applicable. This device is a physical medical glove, not an AI-powered diagnostic or assistive tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-based device.
The type of ground truth used: For the physical and chemical properties, the "ground truth" is defined by the objective measurements and parameters set forth in the ASTM standards (e.g., specific tensile strength values, elongation percentages, maximum allowable pinholes per unit, maximum powder/protein content). For biocompatibility, the ground truth is established by the observed biological response in animal models (absence of primary skin irritation or contact sensitization).
The sample size for the training set: Not applicable, as no algorithm or AI model was involved that would require a training set.
How the ground truth for the training set was established: Not applicable.

Summary

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K013942

Submitter: 1.0

Name :	WRP Specialty Products Sdn. Bhd.
Address :	Lot 11, Jalan 2, Kawasan Perusahaan Bandar Baru SalakTinggi, 43900 Sepang, Selangor Darul Ehsan, MALAYSIA
Phone No. :	+60 3 8706 9788
Fax No. :	+60 3 8706 5020

November 09, 2001 Date of Summary Prepared :

Contact Person: 2.0

Name:	Mr. Mohd Haizan Hussein
Phone No.:	+603 8706 9788
Fax No.:	+603 8706 5020

Name of the device: 3.0

Proprietary or Trade Name	: 1. Dermagrip, and2. Multiple or Customer's Trade Name
Classification Name	: Patient Examination Gloves (per 21 CFR 880.6250)
Device Name	: Powder Free Blue Latex Examination Glove, Non-sterile (Protein Content Labeling)

Identification of The Legally Marketed Device: 4.0

Class I patient examination gloves, 80LYY, powder free, that meets all the State - Patison ASTM standard D 3578 - 01 Type I and FDA 21 CFR 800.20.

Description of The Device: 5.0

The Powder Free Blue Latex Examination Glove, Non-sterile (Protein Content Labeling) meets all the requirements of ASTM standard D 3578 - 01 Type I and FDA 21 CFR 800.20.

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6.0 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 finger to prevent contamination between patient and examiner.

7.0 Summary of the Technological Characteristics of the Device:

The Powder Free Blue Latex Examination Glove, Non-sterile (Protein Content Labeling) is summarized with the following technological characteristics compared to ASTM or equivalent standards.

Characteristics	Standards	Device Performance
Dimensions	ASTM D 3578 - 01	Meets
Physical Properties	ASTM D 3578 - 01	Meets
Freedom from pinholes	ASTM D 3578 - 01FDA 21 CFR 800.20	Meets
Powder-Free	ASTM D 6124 - 00	< 2 mg/glove
Protein Level	ASTM D 5712 - 99	< 50 μg/g
Biocompatability	Primary Skin Irritation inRabbitsDermal Sensitization	Passes(Not a primary skin irritant)Passes(Not a contact sensitizer)

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

The performance test data of the non-clinical tests that support a determination of substantial equivalence is the same as mentioned immediately above.

Substantial Equivalent Based on Assessment of Clinical Performance Data 9.0

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

10.0 Conclusion

It can be concluded that the Powder Free Blue Latex Examination Glove, Nonsterile (Protein Content Labeling) will perform according to the glove performance standards referenced in Section 7 above and meet ASTM standards, and FDA requirements for water leak test on pinhole AQL. Consequently, this device is substantially equivalent to currently marketed devices.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three wavy lines, which may represent water or wind.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 31 2001

Mr. Mohd Haizan Hussein Manager, OA/RA WRP Specialty Products Sdn. Bhd. Lot 11 Jalan 2 Perusahaan Bandar Kawasan Baru Salak Tinggi Sepang, Selangor, MALAYSIA

Re: K013942

Trade/Device Name: Powder Free Blue Latex Examination Glove, Non-Sterile (Protein Content Labeling) Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: November 9, 2001 Received: November 29, 2001

Dear Mr. Hussein:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,
Les Clatorst

Timot atowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

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INDICATIONS FOR USE

Applicant	WRP Specialty Products Sdn Bhd
510(k) Number (if known):	K013942
Device Name	POWDER FREE BLUE LATEX EXAMINATIONGLOVE, NON-STERILE(PROTEIN CONTENT LABELING)

Indications For Use:

A patient examination glove is a disposable device intended for medical purposes I pairent channiner's hand or finger to prevent contamination between patient and examiner.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter _

Olin S. Lim

on Sign-Off) on Sign-Om)
on of Dental, Infection Control neral Hospital . Imber

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.