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, powdered and meeting all the requirements of ASTM-D3578-99 Standard Specification for Latex Examination Gloves for Medical Application.

AI/ML Overview

The provided text describes the acceptance criteria and performance data for ROYAL SHIELD POWDERED LATEX EXAMINATION GLOVES, rather than a typical AI-driven device. As such, many of the requested categories in the prompt (e.g., sample size for test set, number of experts, adjudication method, MRMC study, training set size, etc.) are not applicable to the documentation provided for this type of medical device clearance.

However, I can extract the relevant information regarding acceptance criteria and reported performance from the document.

Acceptance Criteria and Reported Device Performance for ROYAL SHIELD POWDERED LATEX EXAMINATION GLOVES

1. Table of Acceptance Criteria and Reported Device Performance

Category	Characteristic	Acceptance Criteria (ASTM-D3578-99 / FDA)	Reported Device Performance
Dimension	Width (X-Small)	70 mm +/- 10 mm	70 mm +/- 10 mm
	Width (Small)	80 mm +/- 10 mm	80 mm +/- 10 mm
	Width (Medium)	95 mm +/- 10 mm	95 mm +/- 10 mm
	Width (Large)	111 mm +/- 10 mm	111 mm +/- 10 mm
	Width (Size 5.5)	70 +/- 10 mm	70 +/- 10 mm
	Width (Size 6.0)	76 +/- 10 mm	76 +/- 10 mm
	Width (Size 6.5)	83 +/- 10 mm	83 +/- 10 mm
	Width (Size 7.0)	89 +/- 10 mm	89 +/- 10 mm
	Width (Size 7.5)	95 +/- 10 mm	95 +/- 10 mm
	Width (Size 8.0)	102 +/- 10 mm	102 +/- 10 mm
	Width (Size 8.5)	108 +/- 10 mm	108 +/- 10 mm
	Width (Size 9.0)	114 +/- 10 mm	114 +/- 10 mm
	Length	230 mm	230 mm
	Thickness - Finger	0.08 mm min	0.08 mm min
	Thickness - Palm	0.08 mm min	0.08 mm min
Physical Properties	Tensile Strength (Aged)	14.0	21.8 - 27.3
(ASTM-D3578-99)	Tensile Strength (Unaged)	14.0	25.1 - 27.3
	Ultimate Elongation (Aged)	500	877 - 975
	Ultimate Elongation (Unaged)	700	790 - 922
Water Leak Test	AQL	2.5%	< 2.5% (2 leaks out of 125, 1 out of 125, 2 out of 125 over 3 years)
Biocompatibility	Primary Dermal Irritation	Not a primary irritant	Not a primary irritant
	Skin Sensitization	Not a sensitiser	Not a sensitiser
Residual Protein Level	Total Water Extractable Protein	< 200 µg/g (Claimed Level)	< 200 µg/g

Study Proving Device Meets Acceptance Criteria:

The device's compliance is demonstrated through a series of tests against established standards, primarily ASTM-D3578-99 and FDA requirements.

Dimensional Testing: The provided table shows that the Royal Shield Powdered Latex Examination Gloves meet the specified width, length, and thickness dimensions across various sizes.
Physical Properties (Tensile Strength & Ultimate Elongation): Data from gloves produced in 1994, tested after "Real Time Ageing" in 1997, 1998, and 1999, demonstrates performance that "meets/exceeds ASTM-D3578-95 Standard Specifications." The reported tensile strength and ultimate elongation values for both aged and unaged gloves are significantly higher than the ASTM acceptance criteria.
Water Tight Test (Pinhole Requirements): A 1,000 ml water leak test (FDA specified) was conducted on 80 pieces (batch #9410243147/9411153155, Size L/R 6.0) of gloves produced in 1994. Tests were performed on March 10, 1997 (125 samples), March 10, 1998 (125 samples), and March 11, 1999 (125 samples). The number of leaked gloves was 2, 1, and 2 respectively. These figures are stated to be "within the FDA/draft ASTM requirements for latex exam gloves of 2.5% AQL," indicating compliance with pinhole requirements. This also supports the "SHIELD's shelf life labeling claim of four years."
Biocompatibility: Tests for Primary Dermal Irritation and Skin Sensitization indicated that the gloves are "Not a primary irritant" and "Not a sensitiser," respectively, meeting FDA biocompatibility requirements.
Residual Protein Level: Testing using ASTM D 5712-95 showed a claimed level of "< 200 µg/g" of protein, which meets the device's labeling claim.

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

Test Set Sample Size:
- Water Tight Test: 125 gloves were tested on each of three separate occasions (total of 375 gloves over the multi-year study for this specific test). The text also states "80 pieces of the gloves produced in 1994 over a period of three years of storage were tested," which seems to contradict the 125 samples per test. However, the table explicitly lists 125 samples for each of the three water leak tests. Given the explicit table data, assuming 125 samples per water leak test.
- Physical Properties: The number of gloves tested for tensile strength and ultimate elongation is not explicitly stated in the provided text, but the results are for "gloves produced in 1994" and tested annually over three years.
- Biocompatibility & Residual Protein: Sample sizes are not specified.
Data Provenance: The data is "After Real Time Ageing On Gloves Produced in 1994." This indicates a retrospective analysis of gloves stored over time. The company (Shield Gloves Manufacturer (M) Sdn. Bhd.) is based in Malaysia, suggesting the origin of testing and manufacturing data.

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

N/A. This device clearance is for a physical medical product (gloves) and does not involve image interpretation or diagnostic algorithms where expert ground truth is typically established. The "ground truth" here is defined by objective physical and chemical testing standards (ASTM, FDA).

4. Adjudication Method for the Test Set:

N/A. Not applicable for this type of device testing. Performance is measured against quantitative standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

N/A. This is not an AI-driven or diagnostic device; therefore, an MRMC study is not relevant.

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

N/A. Not applicable, as this is a physical product, not an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for this device is based on established industry standards and regulatory requirements, specifically:
- ASTM-D3578-99 Standard Specification for Latex Examination Gloves for Medical Application.
- FDA specified 1,000 ml water leak test (for AQL/pinholes).
- FDA biocompatibility requirements.
- ASTM D 5712-95 (for residual protein level).

8. The Sample Size for the Training Set:

N/A. As this is a physical product and not an AI/machine learning device, there is no "training set."

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

N/A. No training set is applicable to this product.

Summary

{0}------------------------------------------------

APPENDIX H

510(k) SUMMARY

SUMMARY OF THE SAFETY AND EFFECTIVENESS FOR ROYAL SHIELD POWDERED LATEX EXAMINATION GLOVES

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 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 80LYY, 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 80LYY, 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 mm	5.5	70 +/- 10 mm
	Small	80 mm +/- 10mm	6.0	76 +/- 10mm
	Medium	95 mm +/- 10mm	6.5	83 +/- 10mm
	Large	111mm +/- 10mm	7.0	89 +/- 10mm
			7.5	95 +/- 10mm
			8.0	102 +/- 10mm
			8.5	108 +/- 10 mm
			9.0	114 +/- 10mm
Length		230 mm
Thickness -FingerPalm	0.08 mm min0.08 mm min

{1}------------------------------------------------

2. Physical Properties (ASTM-D3578-99 Standard Specification for Latex Exam Gloves) After Real Time Ageing On Gloves Produced in 1994.

	TENSILE STRENGTH		ULTIMATE ELONGATION
DATETESTED	AGEDSHIELD	AGEDASTM	UNAGEDSHIELD	UNAGEDASTM	AGEDSHIELD	AGEDASTM	UNAGEDSHIELD	UNAGEDASTM
10.3.97	21.8	14.0	25.1	14.0	975	500	922	700
10.3.98	27.3	14.0	27.3	14.0	877	500	790	700
11.3.99	22.0	14.0	26.2	14.0	928	500	854	700

Batch # 9410243147 & 9411153155

3. Water Tight Test After Real Time Ageing

Using the FDA specified 1,000 ml water leak test, 80 pieces of the gloves produced in 1994 over a period of three years of storage were tested and our results are as given below:

BATCH #	DATETESTED	SAMPLE SIZE	LEAK STATUS	NUMBERLEAKED
9410243147/	Mar 10, 1997	125	Yes	2
9411153155	Mar 10, 1998	125	Yes	1
Size L/R 6.0	Mar 11, 1999	125	Yes	2

The above figures are within the FDA/draft ASTM 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

{2}------------------------------------------------

5. Residual Protein Level

TESTS	FDA ALLOWABLE LEVEL	CLAIMED LEVEL
ASTM D 5712-95	-	< 200 µg/gRange:Mean:

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

1. meets/exceeds ASTM- D3578-95 Standard Specifications For Latex Examination Glove,
1. meets FDA pinhole requirements,
1. meets SHIELD's shelf life labeling claim of four years,
1. meets the protein labeling claim level at <200 µg/g.

{3}------------------------------------------------

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 a stylized image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

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: K992417 Royal Shield Non-Sterile Powdered Latex Trade Name: Examination Gloves with Protein Labeling Claim (200 Micrograms or Less of Total Water Extractable Protein per gram) Regulatory Class: I 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, Druq, 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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸ 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 requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your

{4}------------------------------------------------

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
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".

Sincerely yours,

Timothy A. Ulatowski

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

Enclosure

{5}------------------------------------------------

INDICATIONS FOR USE STATEMENT

Applicant: Shield Gloves Manufacturer (M) Sdn Bhd.

K992417 510K Number:

Device Name: Royal Shield Powdered Latex Examination Gloves > Profer Donor ham on less of Total Water extreastable probes gram 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)

OR Over-The-Counter .. Prescription Use ... ... Per 21 CFR 801.109 (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Device 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.