A powder free polymer coated latex examination glove is a disposable device made of natural rubber material intended to be worn on the hand for medical purposes to provide barrier against potentially infectious materials and other contaminants.

Device Description

The Powder Free Polymer Coated Latex Examination Gloves, Sterile, with Protein Labeling claim of 50 micrograms per dm- of glove or less of water soluble protein will meet all the current specification for ASTM D3578.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:

Acceptance Criteria and Device Performance for Wear Safe (Malaysia) Sdn.Bhd. Powder Free Polymer Coated Latex Examination Gloves

1. Table of Acceptance Criteria and Reported Device Performance

Characteristic	Acceptance Criteria (Standards)	Reported Device Performance
Dimensions	ASTM D3578 - 05	Meets
Physical Properties	ASTM D 412 - 06ae1	Meets
Freedom from pin-holes	ASTM D 5151 - 06	Meets
Powder Free Residue	ASTM D 6124 - 06	Meets
Biocompatibility:	Dermal Sensitization (as per ISO 10993-10)	Not a contact skin sensitizer
	Primary Skin Irritation Test (as per ISO 10993-10)	Not a primary skin irritant
Protein Labeling Claim	50 micrograms per dm² of glove or less of water soluble protein	Claimed to meet

Study Details:

Based on the provided document, the study conducted is a non-clinical performance evaluation against established standards for patient examination gloves.

Sample size used for the test set and the data provenance:
The document does not specify the exact sample size used for each test. However, it indicates that the tests were performed according to specified ASTM and ISO standards, which inherently include sampling methodologies. The provenance of the data is Malaysia, as the manufacturer is "Wear Safe (Malaysia) Sdn.Bhd." The data is retrospective in the sense that it reflects testing performed on product samples to demonstrate compliance at the time of the 510(k) submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable to this type of device and study. The "ground truth" for the performance characteristics is established by adherence to the highly standardized and objective testing methods outlined in the ASTM and ISO standards. These standards themselves are developed by expert committees, but the immediate study does not involve human expert adjudication of individual test results in the way it would for, say, diagnostic image interpretation.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
None in the context of human expert adjudication. The "adjudication" is met by following the prescribed methodology of the ASTM and ISO standards. For instance, pinhole testing involves visual inspection of water-filled gloves, and if a leak is observed, it's a pinhole. There isn't an "expert consensus" on whether a pinhole exists; it's a direct observation.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted, and this type of study is not relevant for examination gloves. MRMC studies are typically performed for diagnostic devices (e.g., AI for radiology) where human interpretation is a key component. This device is a barrier protection product.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This device is a physical product (gloves), not an algorithm or AI system. Therefore, standalone algorithm performance is not a relevant concept here.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" is defined by the objective measurement and observation protocols outlined in the referenced ASTM and ISO standards. For example:
- Dimensions: Measured against specified ranges in ASTM D3578.
- Physical Properties: Tensile strength, elongation, etc., measured using ASTM D 412.
- Freedom from pin-holes: Evaluated according to ASTM D 5151 (e.g., water leak test).
- Powder Free Residue: Measured using ASTM D 6124.
- Biocompatibility: Determined through specific in vivo (e.g., animal or human patch tests, though the document doesn't specify if human or animal for this submission) tests following ISO 10993-10 guidelines, where the "ground truth" is the observed biological response (e.g., absence of sensitization or irritation).
The sample size for the training set:
Not applicable. There is no "training set" as this is a physical product, not a machine learning model.
How the ground truth for the training set was established:
Not applicable. There is no training set for this type of device.

Summary

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1 V | 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:

WEAR SAFE (MALAYSIA) SDN. BHD. Lot PT 13726, Jalan Haji Salleh, Off Jalan Meru, 41050 Klang, Selangor Darul Eshan, Malaysia.

APR - 3 2009

Telephone No.: +603 3392 3088 Fax No.: +603 3392 2118

2.0 Contact Person:

Contact:	Mr. SH TAN
E-mail:	shtan@kossan.com.my
Telephone No.:	+603 3291 2657
Fax No.:	+603 3291 0584

3.0 Name of Device:

Trade Name:	Powder Free Polymer Coated Latex Examination Gloves, Sterile, withProtein Labeling claim of 50 micrograms per dm2 of glove or less ofwater soluble protein.
Common Name:	Patient Examination Glove
Classification Name:	Patient Examination Glove.

4.0 Identification of The Legally Marketed Device:

The Powder Free Polymer Coated Latex Examination Gloves, Sterile, with Protein Labeling claim of 50 micrograms per dm2 of glove or less of water soluble protein, Class I Patient Examination gloves, 80LYY, meets all of the requirements of ASTM D3578 Standard Specification for Rubber Examination Gloves.

5.0 Description of Device:

Lot 13726, Jalan Haji Salleh, Batu 5¼ Off Jalan Meru, 41050 Klang, Selangor Darul Ehsan Malaysia. Tel: 603-33923088, Fax: 603-33922599

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Wear Safe (Malaysia) Sdn.Blid. (Company No.204396-X)

6.0 Intended Use of the Device:

The Powder Free Polymer Coated Latex Examination Gloves, Sterile, with Protein Labeling claim of 50 micrograms per dm of glove or less of water soluble protein is a disposable device intended for medical purposes that is intended to be worn on the hand for medical purposes to provide barrier against potentially infectious materials and other contaminants.

7.0 Summary of The Technological Characteristics of The Device:

The Powder Free Polymer Coated Latex Examination Gloves, Sterile, with Protein Labeling claim of 50 micrograms per dm2 of glove or less of water soluble protein possesses the following technological characteristic (as compared to ASTM or equivalent standards):

Characteristic	Standards	Device Performance
Dimensions	ASTM D3578 - 05	Meets
Physical Properties	ASTM D 412 - 06ae1	Meets
Freedom from pin-holes	ASTM D 5151 - 06	Meets
Powder Free Residue	ASTM D 6124 - 06	Meets
Biocompatibility	Dermal Sensitization(as per ISO 10993-10)	Not a contact skin sensitizer
	Primary Skin Irritation Test(as per ISO 10993-10)	Not a primary skin irritant

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

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

9.0 Substantial Equivalent Based on Assessment of Clinical Performance Data

Clinical data are not needed for market cleared examination gloves.

10.0 Conclusion

It can be concluded that the Powder Free Polymer Coated Latex Examination Gloves. Sterile, with Protein Labeling claim of 50 micrograms per dm of glove or less of water soluble protein is safe and effective for use and will perform according to the glove performance standards referenced in Section 7 above, thereby meeting ASTM standards, FDA requirements, and the labeling claims for the product.

Consequently, this device is substantially equivalent to current marketed devices. This summary will include any other information reasonably deemed necessary by the FDA.

Lọt 13726, Jalan Haji Salleh, Batu 5¼ Off Jalan Meru, 41050 Klang, Selangor Darul Ehsan Malaysia. Tel: 603-33923088, Fax: 603-33922599

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains an abstract image of an eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 3 2009

Mr. S.H. Tan Regulatory Affairs Department Manager Wear Safe (Malaysia) SDN BHD Lot PT 13726, Jalan Haji Salleh, Batu 51/4 Off Jalan Meru, 41050 Klang Selangor Darul Ehsan MALAYSIA

Re: K090327

Trade/Device Name: Powder Free Polymer Coated Latex Examination Gloves, Sterile, with Protein Labeling claim of 50 micrograms per dm2 of glove or less of water soluble protein. Regulation Number: 21 CFR 878.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: February 6, 2009 Received: February 9, 2009

Dear Mr. Tan:

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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Page 2 - Mr. Tan

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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Anthony, J. austin ben

Ginette Y Michaud, M.D. Acting 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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Wear Safe (Malaysia) Sdn.Bhd. (Company No.204396-X)

INDICATIONS FOR USE

Applicant:

WEAR SAFE (MALAYSIA) SDN. BHD.

510(k) Number (if known): |くの9つ327

Device Name:

Powder Free Polymer Coated Latex Examination Gloves, Sterile, with Protein Labeling claim of 50 micrograms per dm2 of glove or less of water soluble protein.

Indication For Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shelly Murphy
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K900327

Page 1 of 1

Lot 13726, Jalan Haji Salleh, Batu 5¼ Off Jalan Meru, 41050 Klang, Selangor Darul Ehsan Malaysia. Tel: 603-33923088, Fax: 603-33922599

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.