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.

Device Description

Class I latex patient examination gloves 80LYY, powder free and meeting all the requirements of ASTM-D3578-95 Standard Specification for Latex Examination Gloves for Medical Application.

AI/ML Overview

This document describes the acceptance criteria and supporting studies for the ROYAL SHIELD POWDER FREE LATEX EXAMINATION GLOVES WITH BUBBLE GUM SCENT AND PROTEIN CONTENT LABELING.

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria (from ASTM-D3578-95 unless otherwise specified)	Reported Device Performance (ROYAL SHIELD)
Dimension
Width (X-Small)	70 mm +/- 10 mm	70 - 75 mm
Width (Small)	80 mm +/- 10 mm	80 - 85 mm
Width (Medium)	95 mm +/- 10 mm	90 - 97 mm
Width (Large)	111 mm +/- 10 mm	105 - 111 mm
Length (all sizes)	230 mm minimum	242 mm
Thickness (Finger)	0.08 mm min	0.08 mm min
Thickness (Palm)	0.08 mm min	0.08 mm min
Tensile Strength (Before Aging)	14.0 Mpa min	21.0 Mpa
Tensile Strength (After Aging - 22 hrs @ 100C)	14.0 Mpa min	16.0 Mpa
Ultimate Elongation (Before Aging)	700 %	800 %
Ultimate Elongation (After Aging - 22 hrs @ 100C)	500 %	750 %
Water Tight Test (AQL)	4.0% AQL (based on FDA/ASTM requirements)	For 200 samples per size: - X-Small: 2 leaked (1%) - Small: 2 leaked (1%) - Medium: 1 leaked (0.5%) - Large: 4 leaked (2%) (All percentages are within 4.0% AQL)
Biocompatibility - Primary Dermal Irritation Test	Must not be a primary irritant	Not a primary irritant
Biocompatibility - Skin Sensitization Study	Must not be a sensitizer	Not a sensitiser
Residual Powder Content (per ASTM D 6124-97)	2 mg/glove max (FDA internal requirement)	Range: 1.5 - 1.9 mg/glove (Mean: 1.7 mg/glove)
Presence of Cornstarch	Negative	Negative
Residual Protein Level (per ASTM D 5712-95)	< 50 µg/g (FDA allowable level)	< 50 µg/g (Range: 27-33 µg/g, Mean: 30 µg/g)

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

Water Tight Test: 200 gloves per size (X-Small, Small, Medium, Large), for a total of 800 gloves. The provenance of this data is not explicitly stated (e.g., country of origin, retrospective/prospective). It is presented as internal test results for "SHIELD's" product.
Other Physical Properties (Dimension, Tensile Strength, Elongation): The sample sizes are not explicitly stated for these tests beyond the reported direct performance values for "SHIELD's".
Biocompatibility: The specific sample sizes for the Primary Dermal Irritation Test and Skin Sensitization Study are not provided, only the "RESULTS."
Residual Powder Content & Presence of Cornstarch: The specific sample size for these tests is not explicitly stated beyond "Range: 1.5-1.9mg/glove Mean : 1.7 mg/glove".
Residual Protein Level: Same as above, not explicitly stated beyond "Range: 27-33 Mean: 30".

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This document pertains to the physical and chemical testing of a medical device (examination gloves), not to a study requiring expert interpretation or ground truth establishment in a diagnostic or clinical context.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human interpretation or subjective assessment that would require an adjudication method.

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

No, an MRMC comparative effectiveness study was not done. This document describes the performance characteristics of an examination glove against established physical, chemical, and biological standards, not the comparative effectiveness of a diagnostic tool or a treatment with human readers.

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

Not applicable. This document is about a physical medical device (gloves), not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth used for these tests are established industry standards and regulatory requirements, specifically:

ASTM-D3578-95 Standard Specification for Latex Examination Gloves for Medical Application: This standard defines the physical properties (dimensions, tensile strength, ultimate elongation) that the gloves must meet.
FDA specified 1,000 ml water leak test / FDA/ASTM requirements for latex exam gloves of 4.0% AQL: This defines the leakage acceptance rate.
FDA biocompatibility requirements: These are the benchmarks for the dermal irritation and sensitization tests.
FDA INTERNAL REQUIREMENT (2 mg/glove max) for Residual Powder Content (per ASTM D 6124-97): This specifies the maximum allowable powder.
FDA ALLOWABLE LEVEL (< 50 µg/g) for Residual Protein Level (per ASTM D 5712-95): This sets the maximum allowable protein.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI-based device, so there is no training set.

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

Not applicable. There is no training set for this device.

Summary

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APPENDIX H

510(k) SUMMARY

SUMMARY OF THE SAFETY AND EFFECTIVENESS FOR ROYAL SHIELD POWDER FREE LATEX EXAMINATION GLOVES WITH BUBBLE GUM SCENT AND PROTEIN CONTENT LABELING

Contact person : Ong Lay Mau

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

Device Information:

Trade Name - ROYAL SHIELD POWDER FREE GREEN LATEX EXAM GLOVES Common Name - Exam gloves Classification Name - Patient examination glove (per 21 CFR 880.6250) Classification Information - Class I latex patient examination glove 80L YY, powder free and meeting all the requirements of ASTM-D3578-95 Standard Specification for Latex Examination Gloves for Medical Application.

Device Description:

Class I latex patient examination gloves 80LYY, powder free and meeting all the requirements of ASTM-D3578-95 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.

Technological Characteristics of Device:

1. Dimension

DIMENSION	ASTM D3578-95	ROYAL SHIELD
X-SmallSmallMediumLarge	70 mm +/- 10 mm80 mm +/- 10mm95 mm +/- 10mm111mm +/- 10mm	70 - 75 mm80 - 85 mm90 - 97 mm105 - 111 mm
Length	230 mm minimumfor all sizes	242mm
Thickness -FingerPalm	0.08mm min0.08mm min	0.08 mm min0.08 mm min

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	TENSILE STRENGTH		ULTIMATE ELONGATION
	ASTM-D3578-95	SHIELD's	ASTM-D3578-95	SHIELD's
Before Aging	14.0 Mpa min	21.0 Mpa	700 %	800%
After Aging22 hrs @100C	14.0 Mpa min	16.0 Mpa	500%	750%

2. Physical Properties (ASTM-D3578-95 Standard Specification for Latex Exam Gloves)

3. Water Tight Test

Using the FDA specified 1,000 ml water leak test, 80 pieces of each size of the gloves were tested and our results are as given below:

BATCH #	SIZE	SAMPLE SIZE	LEAK STATUS	NUMBERLEAKED
9903031019	X-Small	200	Yes	2
9903222024	Small	200	Yes	2
9904011027	Medium	200	Yes	1
9903162023	Large	200	Yes	4

The above figures are within the FDA/ ASTM requirements for latex exam gloves of 4.0% AQL.

4. Biocompatibility

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

BIOCOMPATIBILITY TESTS

Primary Dermal Irritation Test

Skin Sensitization Study

RESULTS

Not a primary irritant

Not a sensitiser

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991743

TESTS	FDA INTERNALREQUIREMENT	SHIELD's
Residual PowderContent perASTM D 6124-97	2 mg/glove max	Range: 1.5-1.9mg/gloveMean : 1.7 mg/glove
Presence of Cornstarch	Negative	Negative

5. Total Residual Powder Content & Presence of Cornstarch

6. Residual Protein Level

TESTS	FDA ALLOWABLE LEVEL	CLAIMED LEVEL
ASTM D 5712-95	< 50 µg/g	< 50 µg/gRange: 27-33Mean: 30

Conclusion :-

The data presented indicate that the Royal Shield Powder Free latex examination glove with Bubblegum scent

meets/exceeds ASTM- D3578-95 Standard Specifications For Latex Examination Glove, ﻨﺴ
1. meets FDA pinhole requirements,
meets SHIELD's labeling claim of its being a powder free glove. న.
1. meets the protein labeling claim level at <50 µg/g

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a human figure and an eagle, with the human figure facing the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 3 1999

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

K991743 Re :

Trade Name: Royal Shield™ Non-Sterile Bubble Gum Scented Powder-Free Latex Examination Glove with Protein Content Labeling Claim (50 micrograms or less) Requlatory Class: I Product Code: LYY Dated: May 10, 1999 May 21, 1999 Received:

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 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations 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 (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action.

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Page 2 - Mr. Smith

In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your 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 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 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.fda.gov/cdrh/dsmamain.html".

Sincer ely Timo

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.

510K Number:

Device Name: Royal Shield Powder Free Latex Examination Gloves With Bubble gum seent thotein content labeling claim (50 microgram or Indications For Use :

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)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Prescription Use ... ... Per 21 CFR 801.109

Over-The-Counter........X

Chien S. Lin

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

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.