The Powder Free Blue Nitrile Examination Glove, Non Sterile 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 Nitrile Examination Gloves, Non Sterile meets all the requirements of ASTM standard D 6319 -- 00a53 and FDA 21 CFR 800.20.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the WRP Asia Pacific Sdn Bhd's Powder Free Blue Nitrile Examination Gloves, Non-Sterile, based on the provided document:

This document is a 510(k) summary for a medical device (examination gloves), which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than a comprehensive clinical study report for a novel AI device. Therefore, many of the requested categories for AI/software studies are not applicable.

1. A table of acceptance criteria and the reported device performance

CHARACTERISTICS	Acceptance Criteria (Standards)	Reported Device Performance
Dimensions	ASTM D 6319 - 00aE3	Meets
Physical Properties	ASTM D 6319 - 00aE3	Meets
Freedom from pinholes	ASTM D 6319 - 00aE3 & FDA 21 CFR 800.20	Meets
Powder Residual	ASTM D 6124 - 01	Meets (< 2 mg/glove)
Biocompatibility:
primary Skin Irritation	Primary Skin Irritation in Rabbits	Passes (Not a primary skin irritant)
Dermal Sensitization	Dermal Sensitization (method not explicitly stated)	Passes (Not a contact sensitizer)

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not specify a distinct "test set" sample size in the context of a software or diagnostic algorithm. The performance evaluation is based on testing batches of manufactured gloves against established ASTM and FDA standards. The provenance of the data is from WRP Asia Pacific Sdn Bhd, located in Sepang, Selangor Darul Ehsan, Malaysia. The testing would be considered prospective for each manufactured batch.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This is not applicable as the study involves physical property testing of manufactured gloves, not expert judgment for ground truth in an AI or diagnostic context. The "ground truth" is defined by objective measurements against established technical standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. This is not a study requiring adjudication of expert interpretations for a test set. Physical property testing follows defined laboratory protocols.

5. 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 is not an AI or software device. It is a physical medical device (examination gloves).

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

Not applicable. This is not an AI or software device.

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

The ground truth for the performance claims (dimensions, physical properties, pinholes, powder residual, biocompatibility) is based on objective measurements against established industry standards (ASTM D 6319-00aE3, FDA 21 CFR 800.20, ASTM D 6124-01) and standardized biological tests (Primary Skin Irritation in Rabbits, Dermal Sensitization).

8. The sample size for the training set

Not applicable. This is not an AI or software device that undergoes a "training" phase.

9. How the ground truth for the training set was established

Not applicable. There is no concept of a "training set" for this device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for WRP Asia Pacific Sdn Bhd. The logo consists of the letters "WRP" in a stylized font, followed by the words "WRP Asia Pacific Sdn Bhd" in a simpler font. Below the company name is the number "1 4 7 8 1 7 V".

510(k) SUMMARY

KC22904

1.0 Submitter:

Name: Address:

Phone No .:

Fax No.:

WRP Asia Pacific Sdn Bhd Lot 1, Jalan 3, Kawasan Perushaan Bandar Baru Salak Tinggi, 43900 Sepang, Selangor Darul Ehsan, MALAYSIA +60 3 8706 1486 460 3 8706 1485

2002 Date of Summary Prepared: 3 0 AUG

2.0 Contact Person:

Name:	Mr. Yue Wah, CHOW
Phone No.:	+60 3 8706 1486
Fax No.:	+60 3 8706 1485

3.0 Name of the device:

Trade Name:	1) Dermagrip-N, and2) Multiple or Customers' Trade Name
Device Name:	Powder Free Blue Nitrile Examination Gloves, Non-Sterile
Common Name:	Examination Gloves
Classification Name:	Patient Examination Gloves (per 21 CFR 880.6250)

4.0 ldentification of The Legally Marketed Device:

Class I patient examination gloves, 80LZA, powder free, that meets all the requirements of ASTM standard D 6319 - 00a53 and FDA 21 CFR 800.20.

5.0 Description of The Device:

VA..... D....... ... T.. D... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

The Powder Free Blue Nitrile Examination Gloves, Non Sterile meets all the requirements of ASTM standard D 6319 -- 00a53 and FDA 21 CFR 800.20.

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Image /page/1/Picture/0 description: The image shows the logo for WRP Asia Pacific Sdn Bhd. The logo consists of the letters "WRP" in a bold, stylized font inside of a rounded shape. To the right of the logo is the text "WRP Asia Pacific Sdn Bhd" in a standard font. Below the text is the number sequence "1 4 7 8 1 7 V".

6.0 Intended Use of the Device:

7.0 Summary of The Technological Characteristics of The Device:

The Powder Free Blue Nitrile Examination Gloves, Non Sterile are summarized with the following technological characteristics compared to ASTM or equivalent standards.

CHARACTERISTICS	STANDARDS	DEVICEPERFORMANCE
Dimensions	ASTM D 6319 - 00aE3	Meets
Physical Properties	ASTM D 6319 - 00aE3	Meets
Freedom from pinholes	ASTM D 6319 - 00aE3FDA 21 CFR 800.20	Meets
Powder Residual	ASTM D 6124 - 01	Meets< 2 mg/glove
Biocompatability	Primary Skin Irritation inRabbits	Passes(Not a primary skin irritant)
	Dermal Sensitization	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.

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Image /page/2/Picture/0 description: The image shows the logo for WRP Asia Pacific Sdn Bhd. The logo consists of the letters "WRP" in white, inside of a black oval. To the right of the logo is the company name, "WRP Asia Pacific Sdn Bhd" in black text. Below the company name is the number "1 4 7 8 1 7 V".

9.0 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.

10.0 Conclusion

It can be concluded that the Powder Free Blue Nitrile Examination Gloves, Non Sterile will perform according to the glove performance standards referenced in section 7 above and meet ASTM standards, and FDA requirements for waterleak test on pinhole AQL. Consequently, this device is substantially equivalent to currently marketed devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 03 2002

Mr. Yue Wah Chow Head of Department, QA/RA WRP Asia Pacific Sdn. Bhd. Lot 1. Jalan 3. Kawasan Perusahaan Bandar Baru Salak Tinngi, 43900 Sepang, Selangor Darul Ehsan, MALAYSIA

Re: K022904

Trade/Device Name: Dermagrip Powder-Free Blue Nitrile Examination Gloves Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: 80 LZA Dated: August 30, 2002 Received: September 3, 2002

Dear Mr. Chow:

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. Fxisting 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 CHR 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

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

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Image /page/5/Picture/0 description: The image shows the logo for WRP Asia Pacific Sdn Bhd. The logo consists of the letters "WRP" in a bold, stylized font inside of a black shape. To the right of the logo is the text "WRP Asia Pacific Sdn Bhd" in a clear, sans-serif font. The text is smaller than the logo, but still easily readable.

INDICATIONS FOR USE

Applicant:	WRP Asia Pacific Sdn Bhd
510(k) Number (if known):	K022904
Device Name:	POWDER FREE BLUE NITRILEEXAMINATION GLOVES, NON-STERILE

Indications For Use:

The Powder Free Blue Nitrile Examination Glove, Non Sterile is a disposable device and is made of synthetic rubber intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

Qun S. Lim

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ision Sign-Off) on of Anesthesiology, General Hospital ion Control, Dental Devi

510(k) Number: K022964

Voir Dartnon In D.

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.