The Powder Free Latex Examination Glove is a disposable device made of natural rubber latex that may bear a trace amount of glove powder and is intended to be worn on hands or finger(s) for medical purposes to provide a barrier.against potentially infectious materials and other contaminants.

Device Description

The Powder Free Latex Examination Gloves. Natural or Blue Colour and with Protein Content Labeling Claim is equivalent to the exiting model, i.e. Latex Patient Examination Gloves. Powder Free which had submitted and cleared under 510(k) number K924356.

The differences in this submission are:

With or without colour additive upon customers` preference or request. a)
With protein content labeling claim, i.e. "This latex glove contains 50 micrograms or b) less of total water extractable protein per gram``.

AI/ML Overview

The provided document is a 510(k) summary for a medical device: "Powder Free Latex Examination Gloves, Natural or Blue Colour and with Protein Content Labeling Claim (50 Micrograms or Less)". This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving the safety and effectiveness of a novel device through extensive clinical trials. Therefore, many of the typical clinical study criteria (like sample size for test set, number of experts, adjudication methods, MRMC studies, standalone AI performance, and training set information) are not applicable or not detailed in this type of regulatory filing.

The acceptance criteria are primarily based on established ASTM standards and FDA regulations for patient examination gloves. The "study" proving the device meets these criteria is a series of tests against these standards.

Here's a breakdown based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Characteristics	Acceptance Criteria (Standards)	Reported Device Performance	Outcome
Palm Width (Medium)	ASTM D 3578	91 - 92 mm	Meets
Length (Medium)	ASTM D 3578	285 - 292 mm	Meets
Finger Thickness (Medium)	ASTM D 3578	0.38 - 0.40 mm	Meets
Palm Thickness (Medium)	ASTM D 3578	0.35 - 0.37 mm	Meets
Tensile Strength (Unaged)	ASTM D 3578	22.88 - 30.87 MPa	Meets
Tensile Strength (Aged)	ASTM D 3578	21.05 - 27.60 MPa	Meets
Freedom from pinholes	ASTM D 3578 & FDA 21 CFR 800.20 (Acceptable Quality Level 1.5)	0/125 (meaning 0 failures out of 125 tested, which meets 1/125)	Meets
Visual Inspection - Major defects	In-House Specification (AQL 2.5)	1/125	Meets
Visual Inspection - Minor defects	In-House Specification (AQL 4.0)	1/125	Meets
Powder Residual	ASTM D 3578 & ASTM D 6124 (< 2 mg/glove)	Avg. 0.96 mg/glove	Meets
Protein Content	ASTM D 3578 & ASTM D 5712 (< 50 µg/g)	17 - 29 µg/g	Meets
Biocompatibility - Primary Skin Irritation	16 CFR Part 1500	Not a primary skin irritant	Meets
Biocompatibility - Dermal Sensitization	Buehler Method	Not a contact sensitizer	Meets

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Pinhole Freedom: 125 gloves were tested.
Sample Size for Visual Inspection: 125 gloves for both major and minor defects.
Sample Size for Powder Residual: Not explicitly stated, but an average value (Avg. 0.96 mg/glove) is given, implying multiple samples were measured.
Sample Size for Protein Content: Not explicitly stated, but a range (17 - 29 µg/g) is given, implying multiple samples were measured.
Sample Size for Physical Properties (e.g., dimensions, tensile strength): Not explicitly stated, but averages or ranges are provided, indicative of testing on multiple units.
Data Provenance: The document implies testing was conducted by the manufacturer, Medipure Corporation (M) Sdn Bhd, located in Malaysia. The testing is laboratory-based performance testing, not human clinical trial data. It is inherently retrospective in the sense that these are tests performed on manufactured product batches.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable as the device is a physical product (examination gloves) tested against predefined technical standards and physical properties, not an AI or diagnostic device requiring expert interpretation for ground truth.

4. Adjudication Method for the Test Set

This information is not applicable. The assessment involves objective physical and chemical tests against quantitative standards (e.g., palm width in mm, tensile strength in MPa, protein content in µg/g). There is no "adjudication" in the sense of reconciling differing expert opinions.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted interpretation devices where multiple human readers' performance with and without AI assistance is evaluated. This device is a medical glove, and such a study is irrelevant to its function or regulatory clearance.

6. If a Standalone (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.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by objective, standardized laboratory measurements and tests. These tests align with the specifications outlined in:
- ASTM D 3578 (Standard Specification for Latex Examination Gloves)
- ASTM D 6124 (Standard Test Method for Residual Powder on Medical Gloves)
- ASTM D 5712 (Standard Test Method for Analysis of Aqueous Extractable Protein in Latex and Natural Rubber)
- FDA 21 CFR 800.20 (Medical devices; effectiveness in preventing pinholes in rubber prophylactics and gloves)
- 16 CFR Part 1500 (Federal Hazardous Substances Act regulations, regarding primary skin irritation)
- Buehler Method (for dermal sensitization)
- In-House Specifications (for visual inspection of major and minor defects).

8. The Sample Size for the Training Set

Not applicable. This device is a physical product, not an AI or machine learning model that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. As stated above, this device does not utilize a training set. The "ground truth" for the device's manufacturing and quality control is established by adherence to the standardized tests mentioned in point 7.

Summary

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K061551

AUG 2 4 2006

SPECIAL 510(k) SUMMARY

1.0 Modified Device Identification:

Trade Name	1) Safety + Comfort, and
	2) Multiple or Customers' Trade Name
Device Name	: Powder Free Latex Examination Gloves, Natural or Blue Colour and with Protein Content Labeling Claim (50 Micrograms or Less)
Common Name	: Examination Gloves
Classification Name	: Patient Examination Gloves (per 21 CFR 880.6251)

2.0 Submitter:

Name	: Medipure Corporation (M) Sdn Bhd
Address	: Lot 12, Medan Tasek, Tasek Industrial Estate, 31400 Ipoh. PerakDarul Ridzuan. MALAYSIA
Phone #	: +60 5 291 0060
Fax #	: +60 5 291 0051
FDA Registration #	: 8041177
Device Listing #	: A722779

Date of Summary Prepared: May 24, 2006

3.0 Contact Person:

Name	: Mr. Terence Lim Sin Kooi
Phone #	: +60 5 291 0060
Fax #	: +60 5 291 0051

4.0 Identification of the Legally Marketed Device:

Class I powder free natural rubber latex examination gloves, 80LYY meets all the requirements of ASTM standard D 3578 - 05 and FDA 21 CFR 800.20.

5.0 Predicate Device Information:

Unmodified Device Name	: Latex Patient Examination Gloves, Powder Free
Cleared 510(k)	: K924356
Date Approved	: February 3, 1994

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6.0 Description of Device Modification:

The differences in this submission are:

With or without colour additive upon customers` preference or request. a)
With protein content labeling claim, i.e. "This latex glove contains 50 micrograms or b) less of total water extractable protein per gram``.

All the above options will be subjected to design controls process, whereby risk assessment will be conducted to identify the potential hazards and estimate the risks of colour changed (Refer to Section 5 – Design Control Activities for the modified Device).

The modification of device does not affect the intended use of the device as well as it does not affect its safety and effectiveness.

7.0 Intended Use of the Device:

The Powder Free Latex Examination Glove, Natural or Blue Colour and with Protein Content Labeling Claim is a disposable device made of natural rubber latex and is intended to be worn on hands to provide barrier against potentially infectious materials and other contaminants on medical purposes.

The indication for use and proposed labeling for the device are illustrated in sections 3 & 4.

8.0 Device Description and Comparison:

Access - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

The device description and comparison between unmodified and modified device, i.e. Powder Free Latex Examination Gloves. Natural or Blue Colour and with Protein Content Labeling Claim are as follows.

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T	ab	0
		ﻟ	1
			***

	Device Name
	Unmodified device	Modified Device
510 (K) Number	K924356	K061551
Device Listing Number	A722779	A722779
Proprietary Name	Multiple or Customers'Trade Name	Safety + Comfort andMultiple or Customers'Trade Name
Product Code	80LYY	80LYY
Classification Name	Patient examination gloves.powder free(per 21 CFR 880.6251)	Patient examination gloves,powder free(per 21 CFR 880.6251)
Intended Use	Provide barrier againstpotentially infectiousmaterials and othercontaminants	Provide barrier againstpotentially infectiousmaterials and othercontaminants
Composition of gloves	Natural rubber latex	Natural rubber latex
Color Additive	Without color additive	With or without colouradditive
Protein Content LabelingClaim	Without protein contentlabeling claim	With protein contentlabeling claim
Compliance with ASTMstandards	ASTM D3578ASTM D6124	ASTM D3578ASTM D6124ASTM D5712
Compliance with otherstandards	FDA 21 CFR 800.20	FDA 21 CFR 800.20
Labeling	21 CFR 820.120	21 CFR 820.120

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Table 2

Characteristics	Standards	Device Name		Device
		Unmodifieddevice	ModifiedDevice	Performance
Palm Width(Medium)	ASTM D 3578	90 - 91 mm	91 - 92 mm	Meets
Length (Medium)	ASTM D 3578	285 - 290 mm	285 - 292 mm	Meets
Finger Thickness(Medium)	ASTM D 3578	0.31 - 0.32 mm	0.38 - 0.40	Meets
Palm Thickness(Medium)	ASTM D 3578	0.25 - 0.26 mm	0.35 - 0.37 mm	Meets
Tensile Strength(Unaged)	ASTM D 3578	19.04-32.10MPa	22.88 - 30.87MPa	Meets
Tensile Strength(Aged)	ASTM D 3578	16.40 - 18.35MPa	21.05 - 27.60MPa	Meets
Freedom frompinholes	ASTM D 3578FDA 21 CFR800.20	1/125	0/125	Meets
Visual Inspection- Major defects	In-HouseSpecification	0/125	1/125	Meets(AQL 2.5)
Visual Inspection- Minor defects	In-HouseSpecification	1/125	1/125	Meets(AQL 4.0)
Powder Residual	ASTM D 3578ASTM D 6124	Avg. 1.63mg/glove	Avg. 0.96mg/glove.	Meets< 2 mg/glove
Protein Content	ASTM D 3578ASTM D 5712	21 - 24 µg/g	17 - 29 µg/g	Meets< 50 µg/g
Biocompatability- Primary SkinIrritation	16 CFR Part 1500	Not a primary skinirritant	Not a primary skinirritant	Meets(Non Irritant)
Biocompatability- DermalSensitization	BuehlerMethod	Not a contactsensitizer	Not a contactsensitizer	Meets(Non Sensitizer)

9.0 Conclusion:

The Powder Free Latex Examination Gloves, Natural or Blue Colour and with Protein Content Labeling Claim (50 Micrograms or Less) will perform according to the glove performance standards as 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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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes representing the three branches of government. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.

AUG 2 4 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Terence Lim Sin Kooi Senior Quality Assurance/Regulatory Affairs Manager Medipure Corporation (M) SDN. BHD. Lot 12. Medan Tasek Tasek Industrial Estate, Ipoh Perak 31400 MALAYSIA

Re: K061551

Trade/Device Name: Powder Free Latex Examination Gloves, Natural or blue Colour and with Protein Content labeling Claim (50 Micrograms or less) Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: August 15, 2006 Received: August 17, 2006

Dear Mr. Kooi:

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. Kooi

ﭘﻪ ﭘﻪ

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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Syrtle J. Michael Omd.

Chiu Lin. Ph.D. 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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INDICATIONS FOR USE

510(k) Number (if known):

Device Name:

POWDER FREE LATEX EXAMINATION GLOVES, NATURAL OR BLUE COLOUR AND WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

Indications For Use:

Shalie R.M. Murphy, RD 8/24/04

an-Off) of Anesthesiology, General Hospical, con Control, Dental Devices

Number: K 061551

Prescription Use (Per 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)

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.