Class I latex patient examination gloves 80L Y Y, powdered and meeting all the requirements of ASTM-D3578-99 Standard Specification for Latex Examination Gloves for Medical Application.

AI/ML Overview

This document describes the acceptance criteria and performance data for ROYAL SHIELD PINK COLORED POWDERED LATEX EXAMINATION GLOVES WITH AND WITHOUT STRAWBERRY SCENTING & A PROTEIN LABELLING CLAIM.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Test	Acceptance Criteria (Standard/Claim)	Reported Device Performance
Dimensions
Width (Ambidextrous)	X-Small: 70 mm +/- 10 mm Small: 80 mm +/- 10mm Medium: 95 mm +/- 10mm Large: 111mm +/- 10mm	Not explicitly reported as meeting all ranges, but device description states meeting ASTM-D3578-99. Implied compliance.
Width (Size Fitted)	5.5: 70 +/- 10 mm 6.0: 76 +/- 10mm 6.5: 83 +/- 10mm 7.0: 89 +/- 10mm 7.5: 95 +/- 10mm 8.0: 102 +/- 10mm 8.5: 108 +/- 10 mm 9.0: 114 +/- 10mm	Not explicitly reported as meeting all ranges, but device description states meeting ASTM-D3578-99. Implied compliance.
Length	230 mm	230 mm (Min)
Thickness - Finger	0.08 mm min	0.08 mm min
Thickness - Palm	0.08 mm min	0.08 mm min
Tensile Strength (Aged)	ASTM: 14.0	Range: 24.7 - 27.4
Tensile Strength (Unaged)	ASTM: 14.0	Range: 26.4 - 30.3
Ultimate Elongation (Aged)	ASTM: 500	Range: 900 - 980
Ultimate Elongation (Unaged)	ASTM: 700	Range: 880 - 900
Water Tight Test (AQL)	ASTM D-3578-99 requirement for latex exam gloves of 2.5% AQL	Batch 9009-9037 XS: 5 leaked (sample size 200) Batch 9019-9023 S: 3 leaked (sample size 315) Batch 9030-9039 M: 3 leaked (sample size 200) (All figures within 2.5% AQL)
Biocompatibility - Primary Dermal Irritation	Meet FDA biocompatibility requirements (Not a primary irritant)	Not a primary irritant
Biocompatibility - Skin Sensitization	Meet FDA biocompatibility requirements (Not a sensitiser)	Not a sensitiser
Residual Protein Level (ASTM D 5712-95)	Claimed Level: < 200 µg/g	< 200 µg/g (Range: not provided, Mean: not provided)

Summary of Device Performance Claim: The data presented indicate that the Royal Shield Powdered latex examination glove:

meets/exceeds ASTM-D3578-99 Standard Specifications For Latex Examination Glove.
meets FDA pinhole requirements.
meets the protein labeling claim level at <200 µg/g.

This document does not describe a study involving an AI device or human readers. It pertains to the conformance of latex examination gloves to established medical device standards. Therefore, sections 2-6 and 8-9 are not applicable in their entirety as framed for an AI device study. However, I will map the intent of these questions to the available information.

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

Water Tight Test:
- Batch 9009-9037 XS: 200 gloves
- Batch 9019-9023 S: 315 gloves
- Batch 9030-9039 M: 200 gloves
Tensile Strength & Ultimate Elongation: The sample size for these tests is not explicitly stated in the provided text, but data is reported for multiple tests (e.g., "20 May 99").
Biocompatibility: Sample sizes for the primary dermal irritation and skin sensitization studies are not explicitly stated.
Residual Protein Level: Sample size is not specified.
Data Provenance: The document is a 510(k) summary submitted to the FDA in the United States. The manufacturer is "Shield Gloves Manufacturer (M) Sdn. Bhd." which suggests the company is likely based in Malaysia (Sdn. Bhd. is a common abbreviation for private limited companies in Malaysia). The tests were conducted on specific dates (e.g., "20 May 99", "19 May 99"). This would be considered prospective testing for the purpose of demonstrating compliance for the 510(k) submission.

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. The "ground truth" for glove performance is defined by established international standards (ASTM-D3578-99, ASTM D 5712-95) and FDA biocompatibility requirements, not by expert consensus on individual cases. The measurements are objective physical and chemical tests.

4. Adjudication Method for the Test Set

This question is not applicable. Performance is determined by objective measurements against predefined criteria/standards, not by human interpretation or adjudication in the context of diagnostic performance.

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

No, an MRMC study was not done. This type of study is relevant for diagnostic devices that involve human interpretation, often assisted by AI. This document is for examination gloves, which are physical barriers, not diagnostic tools.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done

No, a standalone algorithm performance study was not done. This is not an AI device. The tests performed are for the physical, chemical, and biological properties of the gloves.

7. The Type of Ground Truth Used

The "ground truth" is defined by established international standards (ASTM-D3578-99, ASTM D 5712-95), FDA pinhole requirements, and FDA biocompatibility requirements. These standards specify acceptable ranges for physical properties (dimensions, tensile strength, elongation), acceptable quality levels (AQL) for watertightness (pinholes), and qualitative outcomes for biological reactions (irritation, sensitization).

8. The Sample Size for the Training Set

This question is not applicable as this is not an AI device that requires a training set. The "training" for a manufacturing process is implicit in quality control and process validation, which are not detailed here in terms of sample sizes for "training data."

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

This question is not applicable as this is not an AI device. The manufacturing process of gloves is governed by established engineering and quality control principles, not by a "training set" with ground truth in the AI sense.

Summary

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APPENDIX F

510(k) SUMMARY

SUMMARY OF THE SAFETY AND EFFECTIVENESS FOR ROYAL SHIELD PINK COLORED POWDERED LATEX EXAMINATION GLOVES WITH AND WITHOUT STRAWBERRY SCENTING & A PROTEIN LABELLING CLAIM

Contact person : Ong Lav Mau

This summary of safety and effectiveness information is being submitted in accordance with the requirement of SMDA 1990.

Device Information:

Trade Name - ROYAL SHIELD COLORED POWDERED LATEX EXAMINATION GLOVES Common Name - Exam gloves

Classification Name - Patient examination glove (per 21 CFR 880.6250)

Classification Information - Class I latex patient examination glove 80LY, powdered and meeting all the requirements of ASTM-D3578-99 Standard Specification for Latex Examination Gloves for Medical Application.

Device Description:

Class I latex patient examination gloves 80L Y Y, powdered and meeting all the requirements of ASTM-D3578-99 Standard Specification for Latex Examination Gloves for Medical Application.

Intended Use of Device:

A medical glove to be worn on the hand of the health care and similar personnel to prevent contamination between health care personnel and patient.

Intended Use of Device:

A medical glove to be worn on the hand of the health care and similar personnel to prevent contamination between health care personnel and patient.

Technological Characteristics of Device:

1. Dimension

DIMENSION		Ambidextrous	Size Fitted
Width		X-Small 70 mm +/- 10 mmSmall 80 mm +/- 10mmMedium 95 mm +/- 10mmLarge 111mm +/- 10mm	5.5 70 +/- 10 mm6.0 76 +/- 10mm6.5 83 +/- 10mm7.0 89 +/- 10mm7.5 95 +/- 10mm8.0 102 +/- 10mm8.5 108 +/- 10 mm9.0 114 +/- 10mm
Length		230 mm
Thickness -	FingerPalm	0.08 mm min0.08 mm min

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	TENSILE STRENGTH				ULTIMATE ELONGATION
DATE	AGED		UNAGED		AGED		UNAGED
TESTED	SHIELD	ASTM	SHIELD	ASTM	SHIELD	ASTM	SHIELD	ASTM
20 May 99	26.7	14.0	26.4	14.0	980	500	880	700
20 May 99	24.7	14.0	27.1	14.0	900	500	900	700
20 May 99	27.4	14.0	30.3	14.0	930	500	900	700

2. Physical Properties (ASTM-D3578-99 Standard Specification for Latex Exam Gloves)

3. Water Tight Test Data

BATCH #	DATETESTED	SAMPLE SIZE	LEAK STATUS	NUMBERLEAKED
9009-9037 XS	19 May 99	200	Yes	5
9019-9023 S	19 May 99	315	Yes	3
9030-9039 M	19 May 99	200	Yes	3

The above figures are within the ASTM D-3578-99 requirements for latex exam gloves of 2.5% AQL.

4. Biocompatibility

The test results below show that the gloves meet FDA biocompatibility requirements:

BIOCOMPATIBILITY TESTS	RESULTS
Primary Dermal Irritation Test	Not a primary irritant
Skin Sensitization Study	Not a sensitiser

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5. Residual Protein Level

TESTS	FDA ALLOWABLE LEVEL	CLAIMED LEVEL
ASTM D 5712-95	-	< 200 $ \mu $ g/gRange:Mean:

The data presented indicate that the Royal Shield Powdered latex examination glove

1. meets/exceeds ASTM- D3578-99 Standard Specifications For Latex Examination Glove,
1. meets FDA pinhole requirements,

1. meets the protein labeling claim level at <200 µg/g.
  .

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Image /page/3/Picture/2 description: The image is a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three abstract shapes that resemble human figures or flowing lines, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 3 1999

Shield Gloves Manufacturer (M) Sdn. Bhd. C/O Mr. E. J. Smith Consultant Smith Associates P.O. Box 4341 Crofton, Maryland 21114

Re : K992418 Royal Shield Non-Sterile Pink Colored Trade Name: Powdered Latex Examination Gloves with or without Strawberry Scent with Protein Labeling Claim (200 Micrograms or Less of Total Water Extractable Protein per gram) Regulatory Class: Product Code: LYY Dated: July 16, 1999 Received: July 20, 1999

Dear Mr. Smith:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (GMP) GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your

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Page 2 - Mr. Smith

premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA asboratoof 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fdag.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

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

Enclosure

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INDICATIONS FOR USE STATEMENT

Applicant: Shield Gloves Manufacturer (M) Sdn Bhd.

K992418 510K Number:

Device Name: Royal Shield Powdered Latex Examination Cloves, Porte color,

This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

Concurrence of CDRH Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number	K992418

Prescription Use ......................... Per 21 CFR 801.109	OR	Over-The-Counter..................
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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.