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

The provided text describes the acceptance criteria and performance of "ROYAL SHIELD POWDER FREE GREEN LATEX EXAM GLOVES." This is a Class I medical device (examination gloves), and the study conducted focuses on demonstrating its physical and chemical properties meet established standards, rather than evaluating an AI-powered diagnostic or therapeutic device. Therefore, many of the requested elements pertaining to AI studies (like MRMC, ground truth establishment for AI, expert qualifications, adjudication methods, training/test set sizes for AI algorithms) are not applicable to this type of device and study.

Here's a breakdown of the acceptance criteria and reported device performance based on the provided text:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Dimension	X-Small: 70 mm +/- 10 mm (width)	X-Small: 70 - 75 mm (width)
	Small: 80 mm +/- 10 mm (width)	Small: 80 - 85 mm (width)
	Medium: 95 mm +/- 10 mm (width)	Medium: 90 - 97 mm (width)
	Large: 111 mm +/- 10 mm (width)	Large: 105 - 111 mm (width)
	Length (all sizes): 230 mm minimum	Length: 242 mm
	Thickness - Finger: 0.08 mm min	Thickness - Finger: 0.08 mm min
	Thickness - Palm: 0.08 mm min	Thickness - Palm: 0.08 mm min
Physical Properties	Tensile Strength (Before Aging): 14.0 Mpa min (ASTM-D3578-95)	Tensile Strength (Before Aging): 21.0 Mpa
	Ultimate Elongation (Before Aging): 700 % (ASTM-D3578-95)	Ultimate Elongation (Before Aging): 800%
	Tensile Strength (After Aging): 14.0 Mpa min (ASTM-D3578-95)	Tensile Strength (After Aging): 16.0 Mpa
	Ultimate Elongation (After Aging): 500% (ASTM-D3578-95)	Ultimate Elongation (After Aging): 750%
Water Tight Test	FDA/ASTM requirements for latex exam gloves of 4.0% AQL (Acceptable Quality Limit)	Batch 9903031019 (X-Small): 0 leaksBatch 9903222024 (Small): 2 leaksBatch 9904011027 (Medium): 0 leaksBatch 9903162023 (Large): Based on other batches, presumably also within AQL.All stated to be "within the FDA/ ASTM requirements".
Biocompatibility	Not a primary irritant (Primary Dermal Irritation Test)	Not a primary irritant
	Not a sensitiser (Skin Sensitization Study)	Not a sensitiser
Residual Powder Content	2 mg/glove max (ASTM D 6124-97, FDA internal requirement)	Range: 1.5-1.9 mg/glove; Mean: 1.7 mg/glove
Presence of Cornstarch	Negative	Negative
Residual Protein Level	< 50 μg/g (ASTM D 5712-95, FDA allowable level)	< 50 µg/g; Range: 27-33 µg/g; Mean: 30 µg/g

Study Information (as applicable to a medical glove)

Sample size used for the test set and the data provenance:
- Water Tight Test: 200 pieces for each size (X-Small, Small, Medium, Large) were tested. This totals 800 gloves across four batches.
- Dimension, Physical Properties, Biocompatibility, Residual Powder, Presence of Cornstarch, Residual Protein Level: Sample sizes for these tests are not explicitly stated, but the "reported device performance" implies sufficient samples were tested to generate ranges and means for these characteristics.
- Data Provenance: The data comes from the manufacturer, Shield Gloves Manufacturer (M) Sdn. Bhd., as part of their 510(k) submission to the FDA. The location implies an origin outside the US (Sdn. Bhd. is a Malaysian company designation). It is prospective in the sense that these tests were conducted on the manufactured product to demonstrate compliance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is not a study assessing diagnostic performance by human experts. The "ground truth" for glove performance refers to meeting established physical and chemical standards as defined by ASTM and FDA requirements.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Performance is measured against objective standards and laboratory tests.
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:
- Not applicable. This is not an AI device or an imaging diagnostic system.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an AI device. The device itself (the glove) is being tested in a standalone manner against physical/chemical criteria.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" refers to established industry standards and regulatory requirements. This includes:
  - ASTM-D3578-95 Standard Specification for Latex Examination Gloves for Medical Application for dimensions and physical properties.
  - FDA specified 1,000 ml water leak test and 4.0% AQL.
  - FDA biocompatibility requirements.
  - ASTM D 6124-97 for Residual Powder Content.
  - ASTM D 5712-95 for Residual Protein Level.
The sample size for the training set:
- Not applicable. This is not an AI device that requires a training set.
How the ground truth for the training set was established:
- Not applicable.

Summary

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APPENDIX H

510(k) SUMMARY SUMMARY OF THE SAFETY AND EFFECTIVENESS FOR ROYAL SHIELD POWDER FREE GREEN LATEX EXAMINATION GLOVES WITH A PROTEIN CONTENT LABELING

Contact person : Ong Lay Mau

Gloves for Medical Application.

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

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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K9911745

	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%

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
9903222024	Small	200	Yes	2
9904011027	Medium	200	Yes
9903162023	Large	200	Yes	ﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ

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

RESULTS

Not a primary irritant

Skin Sensitization Study

Not a sensitiser

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991745

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 Green latex examination glove with a protein labeling claim qualifies to be labeled as such since it

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

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with a human profile incorporated into its body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 23 1999

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

Re : K991745

Royal Shield™ Non-Sterile Powder-Free, Trade Name: Green Latex Examination Glove with Protein Content Labeling Claim (50 micrograms or less) Regulatory 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, 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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Smith

this response to your premarket notification Please note: 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 Radiological Health

Enclosure

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K991745

INDICATIONS FOR USE STATEMENT

Applicant: Shield Gloves Manufacturer (M) Sdn Bhd.

510K Number:

Green Device Name: Royal Shield Powder Free Latex Examination Gloves With Content labeling Claim (50 micrograms or less 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

Chiu S. Lim

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital D 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.