A powder-free 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, Natural Color, Latex Examination Gloves, Non-Sterile meets all the requirements of ASTM standard D 3578-01a22 and FDA 1000 ml Water Leak Test.

AI/ML Overview

The provided documents describe the performance testing of "BPG Latex Examination Gloves" (Powder-Free, Natural Color, Latex Examination Gloves, Non-Sterile) to demonstrate substantial equivalence for a 510(k) submission.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

CHARACTERISTICS	ACCEPTANCE CRITERIA (STANDARDS)	REPORTED DEVICE PERFORMANCE
Dimensions	D 3578-01a2	Meets
Physical Properties	D 3578-01a2	Meets
Freedom from Pinhole	D 3578-01a2 & FDA CFR 800.20 (FDA 1000 ml Water Leak Test)	Meets (Specifically states it meets FDA 1000 ml Water Leak Test)
Powder Amount	D 3578-01a2 & D 6124 - 05	<2 mg/glove
Water Soluble Protein Content	D 3578-01a2 & D 5712-99	<50 µg/dm²
Biocompatibility (Primary Skin Irritation in Rabbits)	Primary Skin Irritation in Rabbits	Pass (No primary skin irritation)
Biocompatibility (Dermal Sensitization)	Dermal Sensitization	Pass (No contact sensitizer)

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

The documents do not explicitly state the sample sizes used for the individual tests (e.g., how many gloves were tested for pinholes, or how many rabbits were used for biocompatibility testing).
The data provenance is retrospective, as these are reports generated to demonstrate compliance with existing standards. The country of origin for the data is implied to be Malaysia, where the submitter, Best Putra Gloves Sdn Bhd, is located.

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

This question is not applicable in this context. For medical devices like examination gloves, the "ground truth" is established by adherence to recognized national and international standards (e.g., ASTM standards, FDA regulations). Performance is measured objectively against these established criteria, not by expert consensus on specific cases, which is more typical for diagnostic AI devices.

4. Adjudication method for the test set:

This question is not applicable. As explained above, the assessment is against objective, predefined standards, not through an adjudication process involving human experts for discrete "cases."

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:

This question is not applicable. The device is a medical glove, not an AI-assisted diagnostic tool. Therefore, MRMC studies and AI-related effect sizes are irrelevant to its evaluation.

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

This question is not applicable. The device is a physical medical glove and does not involve an algorithm. Performance tests directly measure the physical and chemical properties of the glove.

7. The type of ground truth used:

The ground truth used is based on established industry standards and regulatory requirements. Specifically, this includes:
- ASTM (American Society for Testing and Materials) standards (e.g., D 3578-01a2, D 6124-05, D 5712-99) for dimensions, physical properties, pinhole freedom, powder amount, and water-soluble protein content.
- FDA regulations (e.g., CFR 800.20 for pinholes, and the FDA 1000 ml Water Leak Test).
- Standard biocompatibility testing protocols (Primary Skin Irritation in Rabbits, Dermal Sensitization).

8. The sample size for the training set:

This question is not applicable. Medical gloves are not typically "trained" in the way an AI model is. The product is manufactured and then tested for compliance with specifications. There isn't a "training set" in the machine learning sense. The manufacturing process itself is continuously monitored to ensure quality.

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

This question is not applicable for the same reasons as point 8. The "ground truth" for glove manufacturing would be the established manufacturing specifications and quality control parameters derived from the standards mentioned above.

Summary

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Image /page/0/Picture/0 description: The image shows the letters BPG in a bold, sans-serif font. The letters are large and take up most of the frame. The letters are black, and the background is white. The letters are slightly distressed, with some small imperfections and rough edges.

Lot 1357 & 1358, Jln Kg. Mohd Taib, Kawasan Perindustrian Sg. Choh
48000 Rawang, Selangor Darul Ehsan, Malaysia.
Tel: +03-6092 1042, +03-6092 1142 Fax: +03-6091 2820
E-mail: bpg@streamyx.com Website: www.bpgloves.com

Image /page/0/Picture/3 description: The image contains two logos. The first logo on the left has the text "nqa. ISO 9001 Registered" and the UKAS logo with the number 015. The second logo on the right has the text "nqa. ISO 14001 Registered" and the UKAS logo with the number 015.

510 (K) SUMMARY

<101105
p'd

1.0 Submitter:

Name	: Ratnam S.Vythilingam
Address	: Best Putra Gloves Sdn Bhd, Jln Kg Mohd Taib, Kawasan Perindustrian Sg Choh, 48000, Rawang, Selangor Darul Ehsan. Malaysia
Phone No.	: +03-60921042
Fax No.	: +03-60912820

NOV 10 2010Date of Summary Prepared: 20 August 2010

2.0 Contact Person:

Name	Dr. Effendi Tenang
Phone No.	+03-60921042
Fax No.	+03-60912820

3.0 Name of the device:

Trade Name	:1) BPG Latex Examination Gloves
	2) Multiple or Customers' Trade Name
Device Name	: Powder-Free, Natural Color, Latex Examination Gloves,
	Non-Sterile
Common Name	: Examination Gloves
Classification Name	: Patient Examination Gloves (Class 1)

Identification of the legally marketed device: 4.0

Class 1 patient examination glovesypowdered/that meets all the requirements of ASTM standard D 3578-01a22 and FDA 4000 ml Water Leak Test.

5.0 Description of the Device:

The Powder-Free, Natural Color, Latex Examination Gloves, Non-Sterile meets all the requirements of ASTM standard D 3578-01a22 and FDA 1000 ml Water Leak Test.

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Image /page/1/Picture/0 description: The image shows the letters BPG in a bold, sans-serif font. The letters are large and take up most of the frame. The letters are black, and the background is white. The letters are slightly pixelated, which suggests that the image may have been scaled up from a smaller size.

BEST PUTRA GLOVES SDN.BHD. (580515-T)

Image /page/1/Picture/3 description: The image contains two logos. The first logo on the left is for ISO 9001 registered by NQA, and the second logo on the right is for ISO 14001 registered by NQA. Both logos also contain the UKAS Management Systems certification mark with the number 015.

K/01105

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6.0 Intended Use of the Device:

A powder-free 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 characteristic of the devices:

The Powder-Free, Natural Color, Latex Examination Gloves, Non-Sterile are summarized with following technological characteristics compared to ASTM or equivalent standards.

CHARACTERISTICS	STANDARDS	DEVICEPERFORMANCE
Dimensions	D 3578-01a2	Meets
Physical Properties	D 3578-01a2	Meets
Freedom from Pinhole	D 3578-01a2FDA CFR 800.20	Meets
Powder Amount	D 3578-01a2D 6124 - 05	<2 mg/glove
Water Soluble ProteinContent	D 3578-01a2D 5712-99	<50 µg/dm²
Biocompatability	Primary SkinIrritation in RabbitsDermal Sensitization	Pass(No primary skin irritation)Pass(No 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 equivalent is the same as mentioned immediately above.

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

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

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BEST PUTRA GLO

Lot 1357 & 1358, Jln Kg. Moha
48000 Rawang, Sela

BEST PUTRA GLOVES SDN.BHD. (580515-T)

Lot 1357 & 1358, Jin Kg. Mohd Taib, Kawasan Perindustrian Sg. Choh
Tel: +03-6092 1042, +03-6092 1142 Fax: +03-6091 2820 E-mail : bpg@streamyx.com Website : www.bpgloves.com

Image /page/2/Picture/3 description: The image contains two sets of logos. The first set includes the "nqa. ISO 9001 Registered" logo and the UKAS logo with the number 015. The second set includes the "nqa. ISO 14001 Registered" logo and the UKAS logo with the number 015.

Conclusion 10.0

It can be concluded that the Powder-Free , Natural Color, Latex 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 Water Leak Test on pinhole AQL. Consequently, this device is substantially equivalent to currently marketed devices.

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Image /page/3/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized symbol that appears to represent human connection or support.

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

Dr. Effendi Tenang Managing Director Best Putra Gloves SDN BHD Lot 1357-1358, JLN Kg. Mohd Taib Kawasan Perindustrian Sg. Choh 48000 Rawang, Selangor Darul Ehsan, Malaysia

NOV 1 0 2010

Re: K101105

Trade/Device Name: Powder-Free, Latex Examination Glove, Natural Color, Non-Sterile, Model: MEPF1 Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: October 4, 2010 Received: October-21, 2010

Dear Dr. Tenang:

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.

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Page 2- Dr. Tenang

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 (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); 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 go to

http://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/ReportalProblem/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,

Susan Juuory
Anthony D. Watson, B.S., M.

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

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

Enclosure

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Image /page/5/Picture/0 description: The image shows the letters BPG in a bold, sans-serif font. The letters are large and take up most of the frame. The letters are black and the background is white.

EST PUTRA GLOVES SDN.BHD. (580515-T)

Image /page/5/Picture/2 description: The image contains two logos side by side. The first logo on the left includes the text "ISO 9001 Registered" and a circular symbol with the letters "ngl" inside. The second logo on the right of the first logo contains a crown and a check mark with the number "915" below. The third logo on the left includes the text "ISO 14001 Registered". The fourth logo on the right of the third logo contains a crown and a check mark with the number "915" below.

NOV 1 0 2010

INDICATIONS FOR USE

510( k ) Number: K101105

Device Name: Powder - Free, Latex Examination Glove, Natural Color, Non-Sterile, Model: MEPF1

Indications For Use:

A powder-Free 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.

Sincerely,

Dr. Effend Tepang

(Managing Director)

Prescription Use (Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of

Elaine S. Mayhall

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

510(k) Number: K101105

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.